AESGP
Issue 381 | February 2026
Euro OTC News
Table of Contents
MEDICINES _______________________________________________________________________________ 3
Regulatory News _____________________________________________________________________________________________ 3
• HMA/EMA Multi-Stakeholder Workshop on Artificial Intelligence __________________________________________________ 3
• EMA Industry Standing Group (ISG) - Meeting 11 DEC 2025 - Highlight report _______________________________________ 3
• HMA-EMA joint Network Data Steering Group meeting - 8 DEC 2025 - meeting minutes _______________________________ 3
• EMA Questions and answers regarding co-processed excipients used in solid oral dosage forms – Published _______________ 4
• EMA Final programming document 2026–2028 _______________________________________________________________ 5
• CMDh Minutes - 9-11 DEC 2025 ___________________________________________________________________________ 6
• CHMP workplan 2026 ___________________________________________________________________________________ 8
• EMA Reflection paper on the qualification of non-mutagenic impurities – Published ___________________________________ 9
• EMA concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development ________ 9
• EMA Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 -
Qualification and Validation - For Feedback by 26 MAR 2026 ___________________________________________________ 10
• TiO2 - Updated EMA QWP Q&A on TiO2 ___________________________________________________________________ 11
• EMA-AESGP Bilateral meeting - 23 JAN 2026 – Highlights _____________________________________________________ 11
Herbal medicines ___________________________________________________________________________________________ 12
• EMA HMPC workplan 2026 ______________________________________________________________________________ 12
• AESGP HMPC Hearing Report -19 NOV 2025 _______________________________________________________________ 13
• EMA HMPC Meeting Report - 19-21 JAN 2026_______________________________________________________________ 13
• Draft EU herbal monograph on Ribes nigrum L., folium - For COMMENTS by 1 MAY 2026 ____________________________ 14
Pharmacovigilance __________________________________________________________________________________________ 14
• 1st EMA/HMA Multi-Stakeholder Forum on EudraVigilance and Signal Detection ____________________________________ 14
• PRAC Workplan 2026 __________________________________________________________________________________ 15
• Revised Q&A on Implementing Regulation (EU) 2025/1466 _____________________________________________________ 15
• European Medicines Agency’s Data Protection Notice for EudraVigilance Human (EV) ________________________________ 16
• Publication by ICH of materials relevant for E2D(R1) and E2B(R3) _______________________________________________ 16
• EMA webpage update - Fees for human medicines – PSUR ____________________________________________________ 16
FOOD __________________________________________________________________________________ 18
EFSA publishes updated guidance on scientific data requirements __________________________________________________ 18
• Food additive applications _______________________________________________________________________________ 18
Food Additives - E 153 _______________________________________________________________________________________ 18
• EFSA Scientific opinion on the amendment of the specifications for vegetable carbon (E 153) as a food additive ____________ 18
Novel food _________________________________________________________________________________________________ 19
• EFSA Update of the statement on the safety of cannabidiol (CBD) as a novel food ___________________________________ 19
EU Biotech Act _____________________________________________________________________________________________ 20
• For Feedback by 20 MAR COB___________________________________________________________________________ 20
Food Additives _____________________________________________________________________________________________ 20
• EFSA Re-evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose
(E 955) in fine bakery wares _____________________________________________________________________________ 20
MEDICAL DEVICES _______________________________________________________________________ 22
MDR/IVDR Implementation ____________________________________________________________________________________ 22
• Innovative Health Initiative (IHI) __________________________________________________________________________ 22
Call 12 launched - proposals by 21 APR 2026, 17:00 CET___________________________________________________________ 22
EC High-level Conference on Medical Devices ___________________________________________________________________ 22
• Brussels - 16 March 2026 _______________________________________________________________________________ 23
MDCG Eudamed WG_________________________________________________________________________________________ 23
• Eudamed Production release 2.22 successfully deployed ______________________________________________________ 23
MDCG Standards WG ________________________________________________________________________________________ 23
• New references harmonised standards MDR/IVDR - Publication in the OJEU _______________________________________ 23
Planned Meetings of Medical Device Coordination Group (MDCG) and Subgroups in 2026 _______________________________ 24
• Update _____________________________________________________________________________________________ 24
Team-NB Letter _____________________________________________________________________________________________ 24
• Cybersecurity in medical devices _________________________________________________________________________ 24
Health Technology Assessment _______________________________________________________________________________ 24
• HTA Coordination Group publishes its 2025 Annual Report _____________________________________________________ 24
ENVIRONMENT __________________________________________________________________________ 26
EMA / pharma industry meeting - Official highlights - 19 DEC 2025 __________________________________________________ 26
Zero Pollution Action Plan - Mid-term review - 29 JAN 2026_________________________________________________________ 26
Industry stakeholder webinar on the revised ERA guideline - EMA summary __________________________________________ 26
CROSS-SECTORIAL NEWS _________________________________________________________________ 27
European Commission's new cybersecurity package - Published ___________________________________________________ 27
AESGP OTC News | February 2026
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Regulatory News
HMA/EMA Multi-Stakeholder Workshop on
Artificial Intelligence
The report and recordings from the HMA/EMA Multi-Stakeholder Workshop on Artificial
Intelligence, held on 20 and 21 November 2025, are available on the EMA website.
Recordings:
Day 1 (20 NOV 2025): Please find the recording at the provided link.
Day 2 (21 NOV 2025): Please find the recording at the provided link.
Report:
The report is available here.
EMA Industry Standing Group (ISG) - Meeting 11
DEC 2025 - Highlight report
EMA has published its Highlight Report of the 15th Industry Standing Group (ISG) meeting that took
place on 11 December 2025. Further information concerning this meeting, including all presentations,
may be found on EMA’ s website here.
HMA-EMA joint Network Data Steering Group
meeting - 8 DEC 2025 - meeting minutes
The EMA has published the official minutes of the HMA-EMA joint Network Data Steering Group meeting
that took place on 8 December 2025.
A brief summary of the meeting minutes is available:
1. Reflection on the experience from the 1st year of NDSG
NDSG members valued positively the progress made by the group, recognizing the importance of
openness and collaboration. Participants highlighted the difference in data preparedness across MS,
NDSG will explore ways to strengthen engagement with NCAs in this regard.
2. EHDS implementation update
Medicines
https://www.ema.europa.eu/en/documents/report/report-hma-ema-multi-stakeholder-workshop-artificial-intelligence-ai_en.pdf
https://www.ema.europa.eu/en/events/hma-ema-multi-stakeholder-workshop-artificial-intelligence-ai
https://www.youtube.com/watch?v=lw1ntJfbUP0&t=19s
https://www.youtube.com/watch?time_continue=10&v=NH4DtfFNWcg&embeds_referring_euri=https%3A%2F%2Fwebtools.europa.eu%2F&source_ve_path=Mjg2NjY
https://www.ema.europa.eu/en/documents/report/report-hma-ema-multi-stakeholder-workshop-artificial-intelligence-ai_en.pdf
https://www.ema.europa.eu/en/documents/report/report-highlights-15th-industry-standing-group-isg-meeting_en.pdf
https://www.ema.europa.eu/en/events/15th-industry-standing-group-isg-meeting
https://www.ema.europa.eu/en/documents/minutes/hma-ema-joint-network-data-steering-group-meeting-8-december-2025_en.pdf
AESGP OTC News | February 2026 4 | 29
Participants noted varying levels of preparedness among MS, the need for incentives for data holders,
balancing data access fees, and the relationship of EHDS with other European health data initiatives.
NDSG will elevate EHDS across the 2026-2027 workplan.
3. EMRN data analytic framework: 1st discussion
The NDSG endorsed the approach presented to the group for drafting the new Network Data Analytics
Framework. The framework will cover use case definition, technology and infrastructure, data
management, analytics, people and processes, security, and monitoring. The drafting will start in
2026, with the adoption planned for Q2-Q3 2026.
4. AI research priorities
The NDSG endorsed the final list of AI research priorities, derived from the multistakeholder survey,
and agreed to publish them on the EMA website. Publication expected in Q1 2026.
5. AI Tools framework to support sharing collaboration on AI tools in the EMRN
The NDSG endorsed an internal framework to support the sharing and coordination of AI tools within
the EMRN. The framework will be piloted in 2026, with further review and potential expansion based
on feedback.
6. Knowledge mining use cases and AI roadmap update
The NDSG discussed progress on prioritising AI use cases across the network and supported moving
from exploration to implementation. The group endorsed a stepwise expansion of knowledge mining
capabilities, building on Scientific Explorer, including the development of additional AI-supported tools
and appropriate governance and validation arrangements.
7. DARWIN EU experience and learnings
The success of DARWIN EU was acknowledged and the group supported moving forward with
DARWIN EU 2.0. The group agreed on the need to increased data granularity of data sources, more
outreach to health data access bodies and the need for integration of DARWIN EU with EHDS.
8. Data Quality and Interoperability
The NDSG was invited to submit any major comments to the final draft of the RWD Quality Framework.
Post meeting note: as no comments were received, the RWD Quality Framework is now considered
as adopted. The document will be published in early 2026.
9. ROG PMS data qualification feasibility study update
The NDSG received an update on the ongoing PMS data qualification feasibility study. The summary
report will be provided to the Heads of Medicines Agencies in Q1 2026.
10. PMS – Feasibility and Working Arrangements
The NDSG discussed initial ideas for defining EMRN working arrangements for PMS data
management over the next 2–3 years. The proposed approach focuses on high-level guidance on
roles and responsibilities, simplification of submission flows, optional NCA involvement in data
qualification, and strengthened EMA-led validation, with further alignment needed on governance, use
cases, and interoperability.
EMA Questions and answers regarding co-
processed excipients used in solid oral dosage
forms – Published
The EMA published “Questions and answers regarding co-processed excipients used in solid oral
dosage forms”, following its adoption by CHMP and CVMP
This Q&A document will enter into effect on 1 August 2026.
The document is structured into 3 main sections and is complemented by 2 annexes, as outlined below.
https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-regarding-co-processed-excipients-used-solid-oral-dosage-forms-h-v_en.pdf-0
https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-regarding-co-processed-excipients-used-solid-oral-dosage-forms-h-v_en.pdf-0
AESGP OTC News | February 2026 5 | 29
1. What is a “co-processed excipient” in the context of these Q&As?
2. How to categorise a co-processed excipient in a finished product using a risk-based approach?
3. What are the regulatory dossier requirements to a co-processed excipient?
4. Annex I: Risk factors and impact ranking table
5. Annex II : Decision tree on risk factor and impact ranking of co-processed excipient (CoPE) with
regard to the critical quality attributes (CQAs) of the finished product
Key Points and Scope
• The document outlines the quality requirements for co-processed excipients (CoPE) used in solid
oral dosage forms in both human and veterinary medicinal products.
• While co-processed excipients (CoPEs) can offer benefits such as improved functionality and
reduced risk of segregation of its individual excipients, they could also introduce additional risks
compared to using individual excipients.
• The use of CoPEs in pharmaceutical formulations can present higher risks due to several factors:
e.g. complexity of composition (inherent variability, unpredictable interactions), quality control
(challenges for analytical methods, batch to batch consistency), formulation development
(complexity of optimisation studies, challenges with scaling up production) and stability issues
due to combination of different materials.
• These Q&As aim to harmonise and clarify dossier requirements for CoPEs using a risk-based
approach. It defines three risk categories for the CoPE and the risk factors the MAH/applicant
should consider to identify the adequate risk category, and the related quality dossier
requirements, which need to be provided by the MAH/applicants as part of new MAA or variations.
• Retrospective application of the Q&As is not intended for marketed products, unless there are
changes to the formulation (e.g. introducing a CoPE or changes to the applied CoPE).
The Overview of comments received on Q&A regarding co-processed excipients used in solid oral
dosage forms has likewise been published.
EMA Final programming document 2026–2028
The EMA has published its final programming document 2026–2028, which sets out its priorities,
challenges, and goals for the next three years, alongside the final work programme for 2026.
• The document outlines EMA’s strategic direction for 2026–2028, built around a renewed vision
— “a fast path from innovation to safe and effective medicines”. It highlights the EMA’s
preparations for major upcoming changes, including the new pharmaceutical legislation, the
One Substance, One Assessment package, European Health Data Space Regulation
(EHDS) , as well as other legislative proposals such as the Critical Medicines Act, the Biotech
Act, and the revision of the Medical Devices and In Vitro Diagnostics Regulations.
• The multi-annual programme is anchored in the European medicines agencies network strategy
to 2028 (EMANS), guiding transformation across six strategic areas: 1) improving accessibility
of medicines; 2) leveraging data, digitalisation and AI; 3) advancing regulatory science,
innovation and competitiveness; 4) strengthening preparedness to address antimicrobial
resistance and other health threats; 5) ensuring availability and supply of medicines; and
6) securing the sustainability of the Network. These priorities reflect the evolving scientific,
technological, and societal landscape and positions EMA and its regulatory partners within the
Network to respond effectively to emerging challenges.
• For its 2026 targets, EMA identifies three focus areas: building on the proposed legislative
changes to 'Reimagine EMA', supporting innovation for public and animal health, and
ensuring investment in EMA staff and the Network of tomorrow. The EMA highlights a unique
opportunity to adapt the regulatory system to deal with rapid scientific and technological
advances, as well as to increase efficiency through smart digitalisation and use of artificial
intelligence. EMA also plans to reinforce its early development support to enable new
medicines to be authorised in the EU as rapidly as possible.
https://www.ema.europa.eu/en/documents/comments/overview-comments-received-qa-regarding-co-processed-excipients-used-solid-oral-dosage-forms-h-v-ema-chmp-cvmp-qwp-422493-2024_en.pdf
https://www.ema.europa.eu/en/documents/comments/overview-comments-received-qa-regarding-co-processed-excipients-used-solid-oral-dosage-forms-h-v-ema-chmp-cvmp-qwp-422493-2024_en.pdf
https://www.ema.europa.eu/en/documents/report/final-programming-document-2026-28_en.pdf
AESGP OTC News | February 2026 6 | 29
• The document also underscores the importance of reinforcing trust in science, enhancing
communication to diverse audiences - particularly younger generations, and deepening
engagement with stakeholders, including patients, healthcare professionals, academics, and
international regulators.
• Finally, it is important to note that the document reflects EMA’s planned activities and initiatives
based on the knowledge available at the time of drafting. Should pieces of legislation with
significant impact on the Agency's activities be published in the period following the mailing of this
document to the Management Board, then the Agency may come back to the Board in the course
of 2026 with a proposal for an amended/updated Single programming document.
CMDh Minutes - 9-11 DEC 2025
The minutes of the CMDh meeting held on 9-11 DEC 2025 have been published. Among the items
reported, the following may be noted:
WORKING PARTY ON VARIATION REGULATION
The WP Chair reported from the December 2025 WP meeting.
The WP chair provided an update on the work done following the revision of the EC Variations Guidelines,
which will apply from 15 January 2026, and announced the upcoming network training and public session.
Following a request related to PLM, it was clarified that the RMS should communicate to the MAH in his
country whether Type IA/IAIN notifications are accepted or rejected within 30 days following receipt.
However, if this communication is not received, the variation will be considered automatically accepted.
No need to update the guidance was identified. This approach was supported by the CMDh.
Regarding the issues with partial approvals in worksharing procedures issued by some RMSs, it was
acknowledged that the CMDh agreed that the outcome of the procedures applies to all MAs and MSs
concerned, except in cases where partial approval relates to specific changes. Some MSs noted that their
automated approval letters can only include MAs approved in their country. In such cases, it should be
clearly stated that the assessment covered all authorisations listed in the eAF, even though, for technical
reasons, not all are reflected in the approval letter.
Following the CMDh meetings with IPs in June and November, the VRWP discussed a proposal to waive
the requirement for submitting a worksharing procedure after a previous EU assessment (e.g. following
signals or to adapt to the RefMP), when only national translations need to be assessed. It is not foreseen
in the Regulation that any changes be excluded from mandatory worksharing. The VRWP does not
consider alternative procedures feasible in such cases; submissions should continue to be made through
worksharing (type IB variations). This approach was supported by the CMDh.
It was emphasised that MSs should continue to work to improve the handling of requests to act as
Reference Authority for mandatory worksharing and the adherence to CMDh guidance. Additional
proposals are welcome until the next VRWP.
The VRWP discussed whether the requirement for listing MSs in alphabetical order in section 2 of the eAF
should be maintained for worksharing procedures. The CMDh agreed that a non alphabetical order is not
a validation issue and that purely NAPs should be handled separately from MRP. It was proposed to
update the CMDh Best Practice Guide on Variation Worksharing (Chapter 7) to specify how products
should be listed in the eAF section “Products concerned by this application”. NL will circulate the final
proposal for written agreement until 16 December.
The VRWP also discussed a question on whether the variation regulation is applicable to homeopathic
products registered according to article 14 of Directive 2001/83/EC (i.e. simplified registrations) following
a request for a WS type II variation for homeopathic registrations. It was agreed that homeopathic products
cannot be included in a WS (as only some MS would allow it), however, in order to avoid duplication of
work and to achieve harmonised outcomes, the AR can be shared with other MS.
Finally, the VRWP discussed a case where a line extension was submitted only including changes to the
container and excipients of the original MA. The MAH wants to keep the old formulation and to add a new
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2025_12_CMDh_Minutes.pdf
AESGP OTC News | February 2026 7 | 29
MA for the new formulation. It was agreed that the changes applied for do not constitute a change of the
pharmaceutical form nor a switch from single dose to multidose; therefore, the application cannot be
considered a line extension. However, it was agreed that a new speciality MA can be applied for under
the same MRP number.
CMDH MULTI-ANNUAL WORKPLAN (MAWP)
The draft CMDh MAWP to 2028 will be shared after the meeting for comments until the next plenary
meeting in January.
INTERNATIONAL PHARMACEUTICAL REGULATORS PROGRAMME (IPRP)
ES reported from the IPRP meeting held on 19-20 November 2025 in Singapore, including topics on
strategies against antimicrobial resistance, reliance practices and worksharing approaches, the use of AI
in medicines regulation and therapeutic development, experiences in the implementation of ICH
Guidelines, as well as updates from all working groups. CMDh/EU representative in these working groups
(e.g. bioequivalence WG for generics) should be reminded to report to the CMDh, when relevant.
REGULATORY OPTIMISATION GROUP (ROG)
DE reported from the ROG meeting with industry representatives held on 17 November 2025. DE briefed
the CMDh on the ongoing discussions in the group, such as the industry proposal to start a pilot on type
IA variations via PMS instead of the submission of variations and the retake of the ROG proposal to
replace the cover letter for Type IA variations with CESP delivery file.
HMA TASK FORCE ON MONITORING HORIZONTAL LEGISLATION
IT reported from the HMA task force on monitoring horizontal legislation meeting held on 28 November
2025 and on the change in the mandate of EMACOLEX to add the task of identifying and describing on
HMA request the potential impact of horizontal legislative proposals on pharmaceutical and medical
devices.
ENVIRONMENTAL RISK ASSESSMENT (ERA)
It was noted that in case of MRP/RUP the procedure should not be started until Phase I ERA studies are
available.
It was further noted that several consortia are being formed across the EU to produce ERA data, but
applicants should also commit to generate the relevant data in case this cannot be obtained from a
consortium. In case ERA data by the originator exists, generics should be able to rely on this data. Generic
applicants are encouraged to follow the decision tree included in the ERA guideline.
The EMA informed the CMDh that the report from the second industry stakeholder webinar on the revised
guideline on the environmental risk assessment of medicinal products for human use has been finalised
and will be published soon.
BISPHENOL-A (BPA) BAN IN FOOD CONTACT MATERIALS
The CMDh was informed about questions submitted by a MAH to a NCA in relation to Commission
Regulation (EU) 2024/3190, which came into force in January 2025 and bans the use of bisphenol A (BPA)
in food contact materials. The MAH enquired about the applicability of the Regulation to medicinal
products.
The CMDh was made aware of a report on divergent opinion between EFSA and EMA on bisphenol-A.
The CMDh agreed to consult NcWP and QWP on the questions and if they would agree with the proposed
answers to the questions raised.
ELECTRONIC SUBMISSION
The CMDh was informed and consulted about proposed changes to the PLM Portal eAF.
A change was proposed to enable non-CAP users to specify which are the packages relevant for an
application. The CMDh considered that this change would not be needed. It only seems applicable for a
limited number of MSs that issue MAs at package level, but for EU procedures all packages will have to
be included in a variation.
The CMDh agreed to loosen the rules for when super-grouping can be applied in the PLM Portal eAF
(although the term “super-grouping” is not correct in all applied situations, the principle of grouping is
possible in such cases as per legislation).
AESGP OTC News | February 2026 8 | 29
The CMDh also agreed to change the label in the web-based eAF from “Reference Member State /
Reference Authority for worksharing” to “Reference Member State / Reference Authority / Authorising
Member State” for all use cases.
BE will investigate if NtA agreement will be needed to implement the changes.
Meeting Report - 27-28 JAN 2026
The report from the CMDh meeting held on 27-28 JAN 2026, has been published. Among the items
reported, the following may be noted:
HANDLING OF TYPE IA VARIATIONS NOT SUBMITTED BEFORE 15 JANUARY 2026
On 15 JAN 2026, the new Variation Guidelines (including updated variation classifications) came into
force. All variations submitted after this date should follow the new guideline. If, unexpectedly, a MAH
identifies one or more Type IA variations that were implemented before 15 January 2026 but not submitted
by that date, the delayed Type IA variations should be submitted promptly and without any further delay
as an “early annual update”, using the old eAF and in accordance with the previous (2013) classification
guideline. The MAH should ensure that all Type IA variations that were implemented before 15 January
2026 are included in this submission.
Further guidance on the application of the revised variations framework can be found on the CMDh
webpage.
CMDH POSITIONS FOLLOWING PSUSA PROCEDURES FOR NATIONALLY AUTHORISED PRODUCTS ONLY
The CMDh, having considered the PSURs on the basis of the PRAC recommendations and the PRAC
assessment reports, agreed by consensus on the variation of the marketing authorisations of medicinal
products containing the following active substances:
• caffeine / codeine / paracetamol / propyphenazone, acetylsalicylic acid / caffeine / codeine
/ paracetamol
Further information regarding the above mentioned PSUSA procedures, including information on the
implementation, will be published on the EMA website.
CHMP workplan 2026
The EMA has published the CHMP workplan 2026, following its adoption by the Committee on 29
January 2026.
The work plan is structured around two main pillars. The first focuses on evaluation activities for human
medicines, while the second covers horizontal activities and other areas.
In 2026, the CHMP will focus on its core scientific and regulatory responsibilities, ensuring high-quality,
timely and consistent benefit–risk assessments of human medicines while further improving the efficiency
and clarity of its evaluation processes.
The CHMP will also advance work in specialised areas ensuring that regulatory decisions adequately
reflect evolving scientific, demographic and clinical realities, with continued emphasis on patient and
healthcare professional involvement and close collaboration with other EMA Committees and Working
Parties. This will be a critical year for preparing the network for the implementation of the new
pharmaceutical legislation, with the CHMP contributing its expertise to support regulatory readiness and
a smooth transition to the new framework.
The following activities from the CHMP Workplan 2026, which are of particular relevance, may be
noted:
• Contribute to the public consultation and finalisation of the patient experience data Reflection
Paper.
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_January_2026.pdf
https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation.html
https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation.html
https://www.ema.europa.eu/en/search?f%5B0%5D=ema_medicine_bundle%3Aema_psusa&f%5B1%5D=ema_search_categories%3A83
https://www.ema.europa.eu/en/documents/work-programme/chmp-work-plan-2026_en.pdf
AESGP OTC News | February 2026 9 | 29
• Continue to explore how best to reflect in the assessment reports the way that patient and
healthcare professional input and patient experience data is assessed and the rationale for
acceptance/exclusion for benefit/risk decision-making, linked with the assessment report
templates optimization.
• Participate in drafting of new ICH guidance on patient experience data and patient preference
elicitation.
• Enhance, integrate and align templates with the overview template across various types of
applications (e.g. extension of indication, generic/hybrid).
• In the context of the CHMP pilot on RWD studies, investigate the feasibility to generate RWE on
disease epidemiology, frailty and standard of care in older patients to support the committee
decision-making.
• Collaborate with the Methodology Working Party (MWP) to review the potential impact of the new
pharmaceutical legislation on the guidance.
The detailed review of the workplan is available here.
EMA Reflection paper on the qualification of non-
mutagenic impurities – Published
The EMA has published the Reflection paper on the qualification of non-mutagenic impurities.
About the reflection paper
This reflection paper considers the safety evaluation of non-mutagenic impurities (NMI) in chemically
synthesised pharmaceuticals and is intended to establish a framework to facilitate future discussions
among stakeholders.
Qualification of NMI may be required when data from the regular (non-)clinical development with the API
batches is not considered sufficient. The aim of this paper is to complement currently available guidelines
addressing qualification of NMI such as ICH Q3A and ICH Q3B. The reflection paper discusses different
non-animal approaches, which may provide more compound-specific information than animal studies with
API batches containing the impurities at low levels.
In summary, when impurity-specific safety information for an NMI is recommended, alternative strategies
to gathering this information may be followed, including the use of existing toxicological data,
read-across, threshold of toxicological concern (TTC), computational and in vitro approaches. This
information can be used in an integrated risk assessment. A weight-of-evidence (WoE) approach that
includes all aspects that determine the level of concern, could be sufficient to decide that the NMI can be
considered safe at the specified level.
The reflection paper in detail is available here.
EMA concept paper for the development of a
reflection paper on the use of Bayesian methods
in clinical development
The EMA has published for public consultation a concept paper for the development of a reflection
paper on the use of Bayesian methods in clinical development. This consultation is opened until 30
April 2026.
The purpose of this concept paper is to address key considerations for studies that utilise Bayesian
statistics in clinical development.
https://www.ema.europa.eu/en/documents/work-programme/chmp-work-plan-2026_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-qualification-non-mutagenic-impurities_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-qualification-non-mutagenic-impurities_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-use-bayesian-methods-clinical-development_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-use-bayesian-methods-clinical-development_en.pdf
AESGP OTC News | February 2026 10 | 29
Problem statement
Frequentist methods have traditionally been the standard approach to data analysis in drug development
and regulatory submissions. Nevertheless, ICH E9 guideline states that Bayesian methods may be used
“when the reasons for their use are clear and when the resulting conclusions are sufficiently robust”.
Further guidance that discusses Bayesian methodology include ICH E11A on pediatric extrapolation, draft
ICH E20 on adaptive designs, and the ACT EU Q&A on complex clinical trials. Also, the use of prior beliefs
is mentioned in the CHMP Guideline for investigation of small populations.
Specific potential applications of Bayesian methods mentioned in the above guidelines include:
• Combining knowledge from previous data with newly generated study data in small populations
• Interim analyses, adaptations, pooling, incorporating external controls data (ACT EU Q&A)
• Extrapolation from adults to paediatric populations or between paediatric populations
In recent years, there has also been an increasing number of proposals in submissions to the EMA that
used Bayesian methods for borrowing of historical or external data to enrich trial data to draw conclusions
in the same or a related population or to draw conclusions in populations where adequately powered trials
are not possible.
Currently, there is lack of clarity on the regulatory position on when Bayesian methods can be accepted
in the confirmatory setting and the methodological requirements needed to address potential regulatory
concerns.
The overall aim of the proposed reflection paper will be to clarify when Bayesian methods may be
considered appropriate in the regulatory setting and to describe the information and justifications required
for their use to support regulatory decision making. It will also emphasise the importance of engaging early
with regulators if Bayesian analyses are intended to be used in a clinical trial.
ACTION
• Any feedback on the concept paper for the development of a reflection paper on the use of
Bayesian methods in clinical development can be submitted by 16 APR.
EMA Concept paper on the revision of the
guidelines on Good Manufacturing Practice for
medicinal products - Annex 15 - Qualification and
Validation - For Feedback by 26 MAR 2026
The EMA has published the Concept paper on the revision of the guidelines on Good
Manufacturing Practice for medicinal products - Annex 15 - Qualification and Validation, which is
available for public consultation until 9 APR 2026.
Annex 15 is currently intended to be used by active substance (AS) manufacturers as an optional
supplementary guidance to the requirements already outlined in EudraLex, Volume 4, Part II, as
reported in the chapter “Principles”: “may also be used as supplementary optional guidance for active
substances without introduction of additional requirements to EudraLex, Volume 4, Part II”. Although
annex 15 is not currently mandatory for AS manufacturers, the applicability of its principles in this sector
is generally recognised. Making annex 15 formally mandatory to active substance manufacturers is
expected to further enhance public health safety by promoting manufacturers to have more oversight and
knowledge about their processes and products. The revised Annex 15 will be applicable to
manufacturers of chemical and biological active substances.
About the proposal
The proposal is to extend the scope of the annex to AS manufacturers and amend the text in selected
areas supplementing and linking with guidance provided in EudraLex, Volume 4, Part II and other
guidance relating to active substances (e.g. GDP). It includes strengthened requirements related to
qualification, validation, change control, and oversight of outsourced activities, in alignment with existing
guidance in EudraLex Volume 4, Part II. It also reinforces expectations for process validation, supplier
https://www.ema.europa.eu/en/ich-e9-statistical-principles-clinical-trials-scientific-guideline
https://www.ema.europa.eu/en/ich-guideline-e11a-pediatric-extrapolation-scientific-guideline
https://www.ema.europa.eu/en/ich-e20-adaptive-designs-clinical-trials-scientific-guideline
https://www.ema.europa.eu/en/ich-e20-adaptive-designs-clinical-trials-scientific-guideline
https://health.ec.europa.eu/system/files/2022-06/medicinal_qa_complex_clinical-trials_en.pdf
https://www.ema.europa.eu/en/clinical-trials-small-populations-scientific-guideline
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-use-bayesian-methods-clinical-development_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-use-bayesian-methods-clinical-development_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf
https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf
AESGP OTC News | February 2026 11 | 29
qualification, investigation of deviations, and verification of transportation, with the aim of improving
process understanding, control, and product quality throughout the lifecycle.
In terms of implementing the principles of Good Distribution Practices of active substances for
medicinal products for human use, to provide more guidance on verification of transportation extending
in this way Part II chapter 10 and emphasising the need to include in product knowledge also consideration
on the impact of transportation to the quality of AS. The proposal will also include targeted revisions of
the text to consider the ICH guideline Q9 (R1) on quality risk management, emphasising a risk-based
approach to qualification, validation, and monitoring systems.
The proposal in detail is available here.
The proposed questions to stakeholders
Although the change in scope of the annex 15 from optional to mandatory as well as the change resulting
from the ICH guideline Q9 (R1) on quality risk management is not expected to have a critical impact
on companies, stakeholders are encouraged to respond to the particular questions listed in Section 6 of
the proposal.
1. What is the current level of use of annex 15 principles in active substance manufacturing in the different
sections of the guideline (process validation, cleaning validation, transport validation, investigations,
qualification, change control) as well as usage of retrospective or concurrent validation approach?
2. What would be the impact of making annex 15 mandatory for active substance manufacturers in the
different sections of the guideline (process validation, cleaning validation, transport validation,
investigations, qualification, change control)?
3. What is the current level of understanding and use of ICH guideline Q9 (R1) on quality risk management
in active substance manufacturing?
4. What would be the impact of the change resulting from ICH guideline Q9 (R1) on quality risk
management?
ACTION:
• Major comments can be sent to to AESGP-medicines@aesgp.eu by 26 MAR 2026.
TiO2 - Updated EMA QWP Q&A on TiO2
EMA has recently updated its Quality Working Party (QWP) Questions and Answers to provide technical
and procedural guidance on the use of titanium dioxide (TiO₂) as colourant in medicines.
The updated list contains the following 5 questions, and it refers to the Staff Working Document published
in August 2025, which addresses regulation 2022/63:
1. What does the Commission staff working document on the use of TiO₂ in medicinal products
mean for pharmaceutical companies developing and/or maintaining an authorisation of medicines
for human and veterinary use?
2. What should I do if I am an applicant of a new MAA that contains TiO₂?
3. What should I do if I am a MAH of an MA containing TiO₂?
4. What are the scientific data requirements to remove/replace TiO₂?
5. What are the regulatory pathways to support a change in excipients to remove/replace TiO₂ in
medicinal products?
EMA-AESGP Bilateral meeting - 23 JAN 2026 –
Highlights
The EMA published the Highlights of the 6th EMA-AESGP bilateral meeting that was held on 23
January 2026.
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015XC0321(01)&from=EN
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015XC0321(01)&from=EN
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf
mailto:AESGP-medicines@aesgp.eu
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-medicines-qa-introduction/quality-medicines-questions-answers-part-2
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-medicines-qa-introduction/quality-medicines-questions-answers-part-2
https://www.ema.europa.eu/en/documents/report/highlights-6th-ema-aesgp-bilateral-meeting_en.pdf
AESGP OTC News | February 2026 12 | 29
Herbal medicines
EMA HMPC workplan 2026
The EMA has published the HMPC workplan 2026, following its adoption by the committee on 21 JAN
2026. The activities outlined in this workplan have been agreed taking into consideration the Agency’s
prioritisation set forth in the EMA multi-annual work programme.
The work plan is structured around two main pillars:
1. Evaluation activities for human medicines, and
2. Horizontal activities and other areas.
It is driven by three key priorities:
• Ensuring the continuity of all HMPC activities (“business as usual”);
• Proceeding with topics for which documents were open for public consultation in 2025 (safe use
of herbal medicines in children, information related to ‘borderline issues’, improve
communication on herbal medicines)
• Exploring new digital features to strengthen the HMPC work.
Among the items reported, the following may be noted:
1.EVALUATION ACTIVITIES FOR HUMAN MEDICINES (OTHER SPECIALISED AREAS AND ACTIVITIES)
➢ Explore new initiatives for the use of real-world data (RWD) and opportunities to use
digitalisation and artificial intelligence (AI) in support of decisions.
➢ HMPC position on the role of European Union herbal monographs and assessment reports
in relationship to borderline issues.
➢ Enhance guidance for the demarcation between medical devices, food supplements,
cosmetics and (traditional) herbal medicinal products, contributing for these products to be
marketed under harmonised conditions in the EU.
➢ Activities in 2026:
1) Evaluate additional DARWIN EU studies to be conducted on (traditional) herbal medicinal
products ((T)HMPs), focusing on clear research questions, in support of EU herbal monographs;
2) Continue the work of the HMPC/EMA real-world evidence (RWE) liaison group on topics of
interest to the Committee related to DARWIN EU studies for (T)HMPs);
3) Explore the new possibilities that digital/AI tools can offer for HMPC assessment work;
4) Extend collaboration with HMA-EMA EU-Innovation Network (EU-IN) – Borderline Classification
subgroup (BLCG) on specific classification issues related to borderline products;
5) Finalise a HMPC reflection paper on the use of information in EU herbal monographs and
assessment reports for borderline issues;
6) Explore cooperation with Heads of Food Safety Agencies (HoA) and EFSA on specific safety
issues related to herbal products.
2. HORIZONTAL ACTIVITIES AND OTHER AREAS - COMMITTEES AND WORKING PARTIES
➢ Development of guidance on particulars for signal detection for (T)HMPs.
➢ Improve signal detection methodology for (T)HMPs, considering their nature, characteristics
and the type of product. This is of importance considering that botanical identification and
phytochemical characteristics in individual case safety reports and other sources of safety
information are sometimes not sufficiently presented.
➢ Improve the evaluation of data from paediatric clinical practice for the safe use of herbal
substances in children.
➢ Develop dedicated criteria/principles for the interpretation of such data, which may support
conclusions on most likely therapeutic areas/acceptable indications of (traditional) herbal
medicinal products used in children.
➢ Activities in 2026:
1) Finalise the reflection paper on particulars for signal detection for (T)HMPs with the contribution
of PRAC;
2) Centralise available expertise related to safety issues on herbal substances/preparations in a
temporary group, supporting HMPC decision-making on safety relevant issues;
3) Finalise a reflection paper on data requirements for (T)HMPs used in children;
https://www.ema.europa.eu/en/documents/work-programme/committee-herbal-medicinal-products-hmpc-work-plan-2026_en.pdf
AESGP OTC News | February 2026 13 | 29
4) Continue cooperation and exchange of views with PDCO for specific questions on the use of
marketed (T)HMPs in paediatric population.
3. HORIZONTAL ACTIVITIES AND OTHER AREAS - PARTNERS AND STAKEHOLDERS
➢ HMPC communication of information on (T)HMPs to the public and other stakeholders.
➢ Expand the sharing of information in a balanced way, which can contribute to a safer use of
(T)HMPs on the EU market.
➢ Activities in 2026:
1) Establish elements for effective communication initiatives about (T)HMPs focused on the
patients and healthcare professionals’ needs, and to identify opportunities and limitations for
NCAs and EMA/HMPC;
2) Explore EMA initiatives to fight misinformation regarding medicinal products;
3) Explore best practices for communicating (T)HMPs interactions with other medicinal products.
4. HORIZONTAL ACTIVITIES AND OTHER AREAS - PROCESS IMPROVEMENT
➢ Improve work-sharing in HMPC activities aiming at sustainability of the European medicines
agencies network (EMRN).
➢ Enhance the sharing/transfer of regulatory and scientific knowledge and experience to the next
HMPC generation.
➢ Activities in 2026:
1) Establish practical guidance and initiatives to ensure the availability of resources to support
HMPC core work, with extended worksharing and increased level of active participation;
2) Review the principles for prioritising the start of the review of existing EU herbal monographs,
considering the availability of NCAs assessors to keep current EU herbal monographs
scientifically up-to-date;
3) Continue cooperation with the European Directorate for the Quality of Medicines & Healthcare
(EDQM topics. ) on specific quality key;
4) Development and delivery of new EU-NTC LMS training course(s) as contribution to the herbal
curriculum.
AESGP HMPC Hearing Report -19 NOV 2025
The EMA has published the report from the AESGP hearing at HMPC meeting, held on 19 NOV
2025.
The report is available here.
EMA HMPC Meeting Report - 19-21 JAN 2026
The report on European Union herbal monographs, guidelines, and other activities from the
EMA Committee on Herbal Medicinal Products (HMPC) meeting, held on 19-21 JAN 2026 has been
published. Among the reported items, the following may be noted:
NEW EUROPEAN UNION HERBAL MONOGRAPHS - FINAL
The HMPC adopted the following new monograph (final) after public consultation:
• Final EU herbal monograph on Hyperici herba/Cimicifugae rhizoma
The final monograph together with supporting documents will be published on the European Medicines
Agency's website.
REVISED EUROPEAN UNION HERBAL MONOGRAPH – DRAFT
The HMPC adopted after systematic review and revision the following revised monograph (draft) for 3-
month public consultation until 15 May 2029:
• Draft revised EU herbal monograph on Ribis nigri folium
https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-aesgp-during-hmpc-november-2025-meeting_en.pdf
https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-aesgp-during-hmpc-november-2025-meeting_en.pdf
https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-aesgp-during-hmpc-november-2025-meeting_en.pdf
https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-19-21-january-2026_en.pdf
https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-19-21-january-2026_en.pdf
https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303
AESGP OTC News | February 2026 14 | 29
The revised monograph (draft) together with supporting documents will be published on the European
Medicines Agency's website.
EUROPEAN UNION HERBAL MONOGRAPHS’ REVIEW
Upon recommendation from the Rapporteurs, the HMPC decided after systematic review according to the
procedure EMA/HMPC/124695/2011 Rev.3, to start the revision procedure for the following monograph
because data were detected that could change the monograph’s content:
• EU herbal monograph on Betulae folium
The revision of the monograph and supporting documents will be added to the HMPC work programme.
The HMPC decided further that, after systematic review, no revision is required for the following
monographs because no new data were detected that could change the monographs’ content:
• EU herbal monograph on Hamamelidis cortex
• EU herbal monograph on Hamamelidis folium
• EU herbal monograph on Hamamelidis folium et cortex aut ramunculus destillatum
The review reports will be published as addenda to the existing assessment reports on the European
Medicines Agency's website.
ASSESSMENTS CLOSE TO FINALISATION (for possible adoption at the HMPC March 2026 meeting)
MONOGRAPH REVISIONS - FINAL
• Liquiritiae radix
MONOGRAPH REVIEWS
• Centaurii herba
• Rusci rhizoma
The EMA has published the three-year work plan for the Quality Drafting Group of the Committee
on Herbal Medicinal Products.
Draft EU herbal monograph on Ribes nigrum L.,
folium - For COMMENTS by 1 MAY 2026
Further to its adoption by the EMA Committee on Herbal Medicinal Products (HMPC) on 21 JAN 2026,
the draft second revision of the European Union herbal monograph on Ribes nigrum L., folium,
has been published for public consultation.
The draft assessment report and draft list of references supporting the assessment of Ribes nigrum
L., folium have also been published.
ACTION:
• Any comments on the draft monograph can be sent using this template by 1 MAY 2026.
Pharmacovigilance
1st EMA/HMA Multi-Stakeholder Forum on
EudraVigilance and Signal Detection
https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303
https://www.ema.europa.eu/en/documents/scientific-guideline/procedure-review-revision-european-union-herbalmonographs-european-union-list-entries-revision-3_en.pdf
https://www.ema.europa.eu/en/search?f%5B0%5D=ema_search_categories%3A85&f%5B1%5D=ema_search_content_type%3Aema_herbal&landing_from=73303
https://www.ema.europa.eu/en/documents/work-programme/three-year-work-plan-quality-drafting-group-qdg-committee-herbal-medicinal-products-hmpc_en.pdf
https://www.ema.europa.eu/en/documents/work-programme/three-year-work-plan-quality-drafting-group-qdg-committee-herbal-medicinal-products-hmpc_en.pdf
https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-ribes-nigrum-l-folium-revision-2_en.pdf
https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-ribes-nigrum-l-folium-revision-2_en.pdf
https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-ribes-nigrum-l-folium-revision-2_en.pdf
https://www.ema.europa.eu/en/medicines/herbal/ribis-nigri-folium
https://www.ema.europa.eu/en/medicines/herbal/ribis-nigri-folium
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Ftemplate-form%2Ftemplate-submission-comments-draft-european-union-herbal-monograph-or-draft-european-union-list-entry_en.doc&wdOrigin=BROWSELINK
AESGP OTC News | February 2026 15 | 29
The recording, slides and summary report of the 1st EMA/HMA Multi-Stakeholder Forum on
Eudravigilance and signal detection that took place on 05 November 2025 have been published on EMA
website.
PRAC Workplan 2026
The PRAC workplan 2026 has been published by EMA on its website.
The workplan is structured into two main sections which are the evaluation activities for human medicines
and horizontal activities.
In 2026, the PRAC will focus on core business activities, including revision of Good Vigilance Practices
(GVPs) and other guidance documents related to pharmacovigilance. The following revisions and
activities have been particularly noted.
• Revise GVP Modules II on ‘Pharmacovigilance system master file (rev 2)’, IV on
‘Pharmacovigilance audits (rev 1)’, and VI on ‘Collection, management and submission of reports
of suspected adverse reactions to medicinal products (rev 2)’, in line with the revised
Implementing Regulation (EU) 520/2012.
• Revise GVP Module IX (rev 2) on ‘Signal management’ in line with the revised Implementing
Regulation (EU) 520/2012.
• Finalise the revision 4 of GVP Module VIII on 'Post-authorisation safety studies' and update of the
related documents.
• Contribute to set-up of the specific adverse reaction follow-up questionnaires (Specific AR FUQ)
repository as defined in the respective guideline .
• Provide expert input for developing a reflection paper on digital tools supporting risk minimisation
measures (RMMs).
The Committee will also provide continued expert input to further develop the use of artificial intelligence
and real-world evidence in regulatory pharmacovigilance activities, as well as strengthen the capacity of
the network through training. The following actions have been noticed.
• Provide expert input to the development of guidance on the use of AI in pharmacovigilance, in
collaboration with the Methodology Working Party (MWP).
• Provide expert input on strengthening (real-world) data analysis via the different pathways
available for evidence generation and routine use of real-world evidence (RWE) to support PRAC
decision-making.
• Provide expert input on supporting the development of guidance on use of RWE for regulatory
purpose in collaboration with Methodology Working Party (MWP).
• Contribute to the implementation of the comments received from the public consultation of the EU
paper on PED .
Revised Q&A on Implementing Regulation (EU)
2025/1466
A revised version of the Q&A on Implementing Regulation (EU) 2025/1466: Amendment of
Regulation (EU) No 520/2012 and conclusion of the Signal Detection in EudraVigilance Pilot by
MAHs has been published.
As reminder, this document provides clarification on key topics of interest to Marketing Authorisation
Holders (MAHs) regarding the termination of the signal detection pilot in EudraVigilance by MAHs. These
changes follow the revision of Implementing Regulation (EU) No 520/2012.
This revision includes
- Clarification to Question 4 in alignment with the applicable regulatory framework.
https://www.ema.europa.eu/en/documents/report/summary-report-first-ema-hma-multi-stakeholder-forum-eudravigilance-signal-detection_en.pdf
https://www.ema.europa.eu/en/events/first-ema-hma-multi-stakeholder-forum-eudravigilance-signal-detection
https://www.ema.europa.eu/en/events/first-ema-hma-multi-stakeholder-forum-eudravigilance-signal-detection
https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac
https://www.ema.europa.eu/en/documents/other/questions-answers-implementing-regulation-eu-2025-1466-amendment-regulation-eu-no-520-2012-conclusion-signal-detection-eudravigilance-pilot-marketing-authorisation-holders_en.pdf
https://www.ema.europa.eu/en/documents/other/questions-answers-implementing-regulation-eu-2025-1466-amendment-regulation-eu-no-520-2012-conclusion-signal-detection-eudravigilance-pilot-marketing-authorisation-holders_en.pdf
https://www.ema.europa.eu/en/documents/other/questions-answers-implementing-regulation-eu-2025-1466-amendment-regulation-eu-no-520-2012-conclusion-signal-detection-eudravigilance-pilot-marketing-authorisation-holders_en.pdf
AESGP OTC News | February 2026 16 | 29
- Amendment to Question 5: The update to the (GVP) IX is scheduled to be implemented in Q2 2026 and
other updates to the Implementing Regulation that take effect as of February 2026.
- Amendment to Question 3: This section has been updated to include an additional paragraph offering
further clarification on key concepts that required greater explanation. In particular, the following has been
added which reflect previous discussions held during meetings with EMA.
“MAHs should determine at which step in the signal-management process EudraVigilance data will be
used. MAHs may decide to screen the database for signal-detection purposes as a primary source with
an established frequency. The use of EudraVigilance should be proportionate to the safety profile and
characteristics of the product and should be integrated and coherent within the MAH’s established high
quality pharmacovigilance procedures and other sources of information. It is expected that MAHs use
EudraVigilance data during the validation and evaluation stages of signal management.”
- Editorial changes
European Medicines Agency’s Data Protection
Notice for EudraVigilance Human (EV)
The EMA has published its Data Protection Notice for Eudravigilance Human.
This Data Protection Notice explains the most essential details of the processing of personal data by the
Agency, which includes:
• the area of pharmacovigilance and information on suspected adverse drug reactions (ADRs) originating
from patients, health care professionals and other sources, which is reported to EV by NCAs and MAHs,
thus supporting the continuous safety of medicines;
• the area of clinical trials and information on suspected unexpected serious adverse reactions(SUSARs)
reported by sponsors6 to EV thus allowing NCAs to evaluate whether an IMP poses an unknown risk to
the trial subject and to take measures to protect the safety of trial subjects, if necessary.
For further details, the document is available.
Publication by ICH of materials relevant for
E2D(R1) and E2B(R3)
ICH has published the following materials that are relevant for E2D(R1) and E2B(R3):
- The ICH E2D(R1) training material (ICH_E2D(R1)_TrainingMaterial_2025_1211.pdf) to support its
implementation by providing practical examples illustrating the concepts used in ICH E2D(R1) and
updates to ICH E2B(R3) coding practices. The material is available on the E2D(R1) page and in the online
ICH training library.
-The E2B(R3) Information Paper that introduces the 3 new values in data element “C.5.4 Study Type
Where reaction(s) / event(s) Were Observed” and clarifies that the value ‘2 = Report from study’ in data-
element “C.1.3 Type of Report” is used for studies as well as for other solicited sources. The updated
Codelist (CL8) is included in the E2B(R3) IG package (https://admin.ich.org/sites/default/files/inline-
files/IG_Complete_Package_v1_11_1.zip)
EMA webpage update - Fees for human
medicines – PSUR
The EMA webpage regarding fees for human medicines has been updated.
https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-data-protection-notice-eudravigilance-human-ev_en.pdf
https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-data-protection-notice-eudravigilance-human-ev_en.pdf
https://database.ich.org/sites/default/files/ICH_E2D%28R1%29_TrainingMaterial_2025_1211.pdf
https://www.ich.org/page/efficacy-guidelines#2-8
https://www.ich.org/page/training-library
https://admin.ich.org/sites/default/files/inline-files/E2B%28R3%29_InfoPaper_MCApproved_20251216.pdf
https://admin.ich.org/sites/default/files/inline-files/IG_Complete_Package_v1_11_1.zip
https://admin.ich.org/sites/default/files/inline-files/IG_Complete_Package_v1_11_1.zip
https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/fees-human-medicines
AESGP OTC News | February 2026 17 | 29
The update concerns section 14 on Periodic Safety Update Report and more particularly subsection
14.1 on “Do I have to pay a fee and if so, how do I calculate it ?”
AESGP OTC News | February 2026 18 | 29
EFSA publishes updated guidance on scientific data
requirements
Food additive applications
EFSA has published its updated “Guidance on the scientific data requirements for an application for
authorisation of a food additive submitted under Regulation (EC) No 1331/2008”. The document is
available here: https://doi.org/10.2903/j.efsa.2026.9778
This guidance revises EFSA’s framework for assessing applications for new food additives or
modifications of existing authorisations. EFSA updated the document to reflect the experience
accumulated since the previous version, as well as advances in analytical techniques, toxicological
methodologies, exposure assessment tools (including updated FAIM and DietEx versions), and
cross-cutting EFSA guidance documents. It also incorporates elements relevant to small particle
assessment, nanomaterials, impurities, and alignment with the most recent OECD test guidelines.
The publication describes in detail the scientific evidence applicants must provide: from identity,
specifications and manufacturing process, to exposure assessment, toxicokinetic and toxicological data
following a tiered approach. Notably, it clarifies expectations regarding in vitro and in vivo testing,
read-across, genotoxicity assessment strategies, data requirements for vulnerable population groups—
including infants below 16 weeks—and environmental considerations where relevant. These updates are
intended to improve transparency, consistency, and completeness in EFSA’s evaluation of food additive
dossiers.
Food Additives - E 153
EFSA Scientific opinion on the amendment of the
specifications for vegetable carbon (E 153) as a
food additive
EFSA has published its scientific opinion on the amendment of the specifications for vegetable carbon
(E 153) as a food additive.
The assessment was triggered by a European Commission request to address earlier data gaps related
to impurities and particle characterisation, based on the re-evaluation of E 153 conducted in 2012.
Food
https://doi.org/10.2903/j.efsa.2026.9778
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9855
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9855
AESGP OTC News | February 2026 19 | 29
The opinion recalls that EFSA’s mandate focused on confirming whether the new technical data submitted
by industry adequately support updates to the EU specifications. In particular, EFSA examined: (1) levels
of toxic elements and PAHs in commercial samples of E 153, (2) the lowest technologically achievable
limits for these impurities, and (3) data on particle size distribution in line with requirements for materials
potentially containing nanoscale fractions. While the submitted impurity data support lowering specification
limits for arsenic, cadmium, mercury and lead, and adding a limit for aluminium as well as PAH4, EFSA
noted that deficiencies in the particle size datasets prevent any amendment of the specification regarding
particle properties at this stage.
In its conclusions, EFSA states that a fraction of small particles, including nanoparticles, is present in all
analysed samples of E 153 and that the risk assessment of this additive should be complemented with
nanoscale considerations. At the same time, the Panel confirms that the impurity data justify revising
existing limits for toxic elements and polycyclic aromatic hydrocarbons. However, due to insufficient
physicochemical characterisation, EFSA cannot currently propose amended specifications for particle size
and morphology.
Novel food
EFSA Update of the statement on the safety of
cannabidiol (CBD) as a novel food
EFSA's Nutrition and Food Innovation Unit has published its Update of the statement on the safety of
cannabidiol (CBD) as a novel food.
In 2021, the EFSA NDA Panel undertook a comprehensive assessment of all the information available in
the scientific literature on CBD as pure substance beyond the information provided on the current NF
applications with the following aim:
• To fully characterise the toxicological profile of CBD as individual substance,
• To assess the potentially adverse effects associated to CBD consumption reported in the
literature,
• To assess the impact of the reported potential of CBD to interfere with drug metabolism, and
• To assess the long-term effects in humans from chronic consumption of CBD as food.
The NDA Panel adopted the outcome of this assessment in 2022. In view of new evidence having become
available since the publication of this statement, the NDA Panel is asked to prepare an updated statement
to transparently review the current data gaps status identified in the available scientific literature regarding
the safety of CBD as a NF.
The Panel concludes that:
• The new literature published since the EFSA CBD Statement (EFSA NDA Panel, 2022) is not
sufficient to address the data gaps and uncertainties previously identified.
• Uncertainties remain regarding the kinetic behaviour and the effects of long-term consumption of
CBD on the liver,neurological functions and the reproductive and immune systems
• Data gaps related to neuronal development are of particular concern, since it continues in humans
up to approximately25 years of age. Additionally, CBD interacts with drug-metabolising enzymes,
indicating a potential for interactions with medicinal drugs.
• Taking all the above into account, the safety of CBD as a novel food cannot be established for
doses exceeding 0.0275mg/kg body weight per day, which corresponds to approximately 2
mg/day for a 70 kg adult, until the relevant safety data become available.
• This provisional value applies to CBD formulations consumed as food supplements with a purity
equal or greater than98%, for which the production process is considered safe, genotoxicity has
been ruled out and that do not involve expo-sure to small particles, including nanoparticles.
• The safety of CBD use in individuals under 25 years of age, pregnant or lactating women, and
those on concurrent medications, cannot be established.
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9862
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9862
AESGP OTC News | February 2026 20 | 29
EU Biotech Act
For Feedback by 20 MAR COB
The EU Biotech Act as proposed by the European Commission, is open for feedback procedure
until 14 APR 2026 (the 8-week feedback period is being extended every day until it is available in all EU
languages).
Scope of the Proposal
As defined in the proposal, the Act applies to health biotechnology products and services throughout
their entire lifecycle, including research, development, manufacturing, placing on the market and use.
The amendments to the General Food Law (Articles 56–61 of the proposal) are not limited to health
biotechnology products and activities. They also apply more broadly to other products, services,
and activities falling within the scope of that legislation.
The proposal establishes a framework of measures to strengthen Europe’s biotechnology and
biomanufacturing sectors and introduces amendments to (among others):
• Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Clinical
Trials Regulation)
• Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin
intended for human application (SoHO Regulation)
• Regulation (EC) No 178/2002 laying down the general principles and requirements of food law
(General Food Law)
The proposal ensures coherence with existing and ongoing legislative revisions, notably the Medical
Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), and proposed
simplification measures in food and feed safety legislation (food and feed simplification package).
The EU Biotech Act also exploits synergies with wider EU legislation, complementing the Critical
Medicines Act and aligning with the Pharmaceutical Strategy for Europe as well as the ongoing
revision of EU pharmaceutical legislation.
Expected Impact on the Self-Care Sector
Given its focus on innovative health biotechnology products, the overall impact on the self-care
sector is expected to be limited.
Food Additives
EFSA Re-evaluation of sucralose (E 955) as a
food additive and evaluation of a new application
on extension of use of sucralose (E 955) in fine
bakery wares
EFSA’s Panel on Food Additives and Flavourings (FAF) has recently published its Re-evaluation of
sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose
(E 955) in fine bakery wares.
The Commission asks the European Food Safety Authority to re-evaluate the safety of food additives
already permitted in the Union before 2009 and to issue scientific opinions on these additives, taking
especially into account the priorities, procedures and deadlines that are enshrined in Regulation (EU) No
257/2010 of 25 March 2010, setting up a programme for the re-evaluation of approved food additives in
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14627-Biotech-Act_en
https://www.efsa.europa.eu/sites/default/files/2026-02/ON-9854.PDF
https://www.efsa.europa.eu/sites/default/files/2026-02/ON-9854.PDF
https://www.efsa.europa.eu/sites/default/files/2026-02/ON-9854.PDF
AESGP OTC News | February 2026 21 | 29
accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food
additives.
Taking into account the available dataset, the Panel concluded that there is no need to change the
current ADI of 15 mg/kg bw per day of sucralose (E 955).
The exposure estimates at the mean and P95 in all population groups for all scenarios considering
the currently authorised uses did not exceed the ADI of 15 mg/kg bw per day for sucralose (E 955).
Therefore, the Panel concluded that there is no safety concern at the reported uses and use levels
for sucralose (E 955) as a food additive.
Based on the available data and the identified uncertainties regarding the potential formation of chlorinated
compounds under the wide range of baking processes that may be applicable for Food Category (FC) 7.2
‘Fine bakery wares’, the Panel could not conclude on the safety of the proposed extension of use of E 955
in this FC.
AESGP OTC News | February 2026 22 | 29
MDR/IVDR Implementation
Innovative Health Initiative (IHI)
Call 12 launched - proposals by 21 APR 2026, 17:00 CET
The Innovative Health Initiative (IHI) has launched IHI Call 12, a single-stage, applicant-driven call for
proposals with five topics, each aligned with one of the specific objectives (SOs) in the Strategic Research
and Innovation Agenda (SRIA):
• Topic 1 (SO1): Boosting innovation for a better understanding of the determinants of health
• Topic 2 (SO2): Boosting innovation through better integration of fragmented health R&I efforts
• Topic 3 (SO3): Boosting innovation for people-centred integrated healthcare solutions
• Topic 4 (SO4): Boosting innovation through exploitation of digitalisation and data exchange in
healthcare
• Topic 5 (SO5): Boosting innovation for better assessment of the added value of innovative integrated
healthcare solutions
For full details of the topics, including the budget breakdown, the call text is available. All documents
relating to the call can be found via the Funding and Tenders Portal and the IHI call documents page.
Proposals must be submitted via the electronic submission system of the Funding and Tenders Portal by
21 APR 2026 at 17:00 CET.
Why apply?
IHI calls for proposals represent an excellent opportunity to take part in ground-breaking cross-sector
collaborative projects that aim to deliver tangible benefits for patients. Participation is open to stakeholders
from academia, industry (including SMEs and mid-sized companies), hospitals, and patients’
organisations.
BACKGROUND
• The Innovative Health Initiative (IHI) is an EU public–private partnership funding health research and
innovation across fields ranging from pharmaceuticals and biotechnology to medical technology and
big data.
• On 4-5 November 2025, the IHI Office held a hybrid brokerage event to facilitate networking and the
early stages of consortium building for call 9. The brokerage platform remains open until the call
deadline, and recordings of the pitches delivered at the event are available here.
EC High-level Conference on Medical Devices
Medical
Devices
https://www.ihi.europa.eu/sites/default/files/flmngr/IHI_Strategic_Research_and_Innovation_Agenda_3.pdf
https://www.ihi.europa.eu/sites/default/files/flmngr/IHI_Strategic_Research_and_Innovation_Agenda_3.pdf
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2026-12-SINGLE-STAGE-01
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2026-12-SINGLE-STAGE-02
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2026-12-SINGLE-STAGE-03
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2026-12-SINGLE-STAGE-04
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2026-12-SINGLE-STAGE-04
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2026-12-SINGLE-STAGE-05
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2026-12-SINGLE-STAGE-05
https://www.ihi.europa.eu/sites/default/files/uploads/Documents/Calls/IHI_Call12_CallText.pdf
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/calls-for-proposals?callIdentifier=HORIZON-JU-IHI-2026-12-SINGLE-STAGE
https://www.ihi.europa.eu/apply-funding/call-documents
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/calls-for-proposals?callIdentifier=HORIZON-JU-IHI-2026-12-SINGLE-STAGE
https://urldefense.com/v3/__https:/cdn.flxml.eu/lt-2199573348-ec3cdde7d0d33d48b6825579fb513aeb__;!!DOxrgLBm!EvUogUvkuFuJQmINoAPTuDzN4IBk8sq9K0eLlTZp9RYjqVxnvKj2adYesqVqLTiI-plPq4JDLxlcK_gUMtuw9IqVcRZCysVzdsb5CXFW$
https://urldefense.com/v3/__https:/cdn.flxml.eu/lt-2199573364-ec3cdde7d0d33d48b6825579fb513aeb__;!!DOxrgLBm!EvUogUvkuFuJQmINoAPTuDzN4IBk8sq9K0eLlTZp9RYjqVxnvKj2adYesqVqLTiI-plPq4JDLxlcK_gUMtuw9IqVcRZCysVzduhdtE18$
AESGP OTC News | February 2026 23 | 29
Brussels - 16 March 2026
The European Commission is organising a high-level conference on medical devices with the
participation of Commissioner Olivér Várhelyi responsible for health and animal welfare, representatives
from EU regulatory authorities, representatives from the Council and the European Parliament and other
experts from EU stakeholders associations.
The conference is organised under the auspices of the Cypriot Presidency of the Council and will take
place on 16 March 2026 (09:30 - 17:00 (CET)). The conference will inspire to take stock some of the main
developments of the sector in the previous years and offer a glimpse into the future. The draft programme
and registration link will be made available by the Commission soon.
For further information on the conference, the dedicated website from the Commission is available here.
MDCG Eudamed WG
Eudamed Production release 2.22 successfully
deployed
The EUDAMED Production release 2.22 (Actors, UDI/Devices and NBs & Certificates modules) has been
successfully deployed.
• EUDAMED restricted
• EUDAMED public
This release brings improvements for all the modules in Production, including DTX and the public
EUDAMED.
The main new functionality is the EMDN versioning.
The details in the Release notes and the updated documentation in the EUDAMED Information Centre
are available.
MDCG Standards WG
New references harmonised standards
MDR/IVDR - Publication in the OJEU
Two new Commission Implementing Decisions on references of harmonised standards in support
of the EU Regulations on medical devices have been adopted on 28 January 2026 and published in the
OJEU today, 30 January 2026:
• Commission Implementing Decision (EU) 2026/193 of 28 January 2026 amending
Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical
implants, biological evaluation of medical devices, clinical investigation of medical devices for
human subjects, non-active surgical implants, sterilization of health care products, biocompatibility
evaluation of breathing gas pathways in healthcare applications and small-bore connectors for
liquids and gases in healthcare applications (OJ L, 2026/193, 30.1.2026, ELI:
http://data.europa.eu/eli/dec_impl/2026/193/oj). This adds 12 new references for the MDR,
reaching 48 overall (17% of the requested)
https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_en
https://webgate.ec.europa.eu/eudamed
https://ec.europa.eu/tools/eudamed
https://webgate.ec.europa.eu/eudamed-help/en/files/EUDAMED%20-%20release%20notes.pdf
http://data.europa.eu/eli/dec_impl/2026/193/oj
AESGP OTC News | February 2026 24 | 29
• Commission Implementing Decision (EU) 2026/197 of 28 January 2026 amending
Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of
health care products and information supplied by the manufacturer (labelling) (OJ L, 2026/197,
30.1.2026, ELI: http://data.europa.eu/eli/dec_impl/2026/197/oj). This adds 6 new references for
the IVDR, reaching 23 overall (47% of the requested).
Additionally, the below links to the Commission websites on MDs and harmonised standards are available:
• Sector: https://health.ec.europa.eu/medical-devices-sector_en
• Harmonised standards: https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-
standards_en
Planned Meetings of Medical Device Coordination Group
(MDCG) and Subgroups in 2026
Update
The Commission has published an update of the planned meeting dates of the MDCG and subgroups for
2026.
The update concerns the MDCG-Notified Bodies Oversight meeting date.
Team-NB Letter
Cybersecurity in medical devices
Team NB has released a letter on cybersecurity in medical devices.
In short, they welcome the revision and further development of the European cybersecurity framework for
medical devices based on guidance and (harmonised) standards and caution against granular technical
requirements in our regulations that will be outdated faster than any legislator may update them. The
principle of state-of-the-art should remain the guiding principle for this as for all other aspects of
development and compliance of medical devices. They deem adjustments as proposed by the
Commission in their draft revision of MDR and IVDR sufficient to enable crosstalk between the
regulatory frameworks for general cybersecurity and medical devices.
Health Technology Assessment
HTA Coordination Group publishes its 2025
Annual Report
The Member State Coordination Group on Health Technology Assessment (HTACG) has published its
2025 Annual Report, providing an overview of the first year of application of the EU Health Technology
Assessment Regulation.
The report presents the key achievements of the HTACG and its four subgroups in 2025, covering joint
clinical assessments, joint scientific consultations and the involvement of experts in these cases. It also
http://data.europa.eu/eli/dec_impl/2026/197/oj
https://health.ec.europa.eu/medical-devices-sector_en
https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf
https://health.ec.europa.eu/document/download/941b23fa-60e9-4efe-bd38-9b2d8649e70c_en?filename=md_events_2026_en.pdf
https://health.ec.europa.eu/document/download/45e9328b-f9f4-4d5b-9f5c-385671560785_en?filename=hta_htacg_annual_report_2025.pdf
AESGP OTC News | February 2026 25 | 29
covers the work undertaken on the identification of emerging health technologies and the development of
methodological and procedural guidance, as well as communication activities with key stakeholders.
In 2025, the HTACG started 13 joint clinical assessments on new oncology products and advanced
therapy medicinal products. The report outlines the preparatory work undertaken to start the joint clinical
assessment of medical devices and in vitro diagnostic medical devices beginning in 2026. The Group has
selected seven joint scientific consultations across two request periods in 2025, including four
consultations in parallel with the provision of scientific advice by the European Medicines Agency (EMA).
Four joint scientific consultations were completed in 2025.
By the end of 2025, 38 patients, carers or clinicians were involved in joint clinical assessments and 10 in
joint scientific consultations. The Annual Report fulfils the requirement under Article 6(4) of the EU Health
Technology Assessment Regulation and provides transparency on the functioning of the EU HTA
framework.
More information:
• Flash report - Member State Coordination Group on HTA (HTACG) (12 February 2026)
• Member State Coordination Group on HTA (HTACG)
• Implementing the EU Health Technology Assessment Regulation
• Regulation 2021/2282 on Health Technology Assessment
https://health.ec.europa.eu/document/download/20b5d8c6-f510-4364-9383-ac39f7d7819e_en?filename=hta_20260216_flash_en.pdf
https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/member-state-coordination-group-hta-htacg_en
https://health.ec.europa.eu/document/download/84c1ec8f-9be3-4073-aceb-330764c93152_en?filename=hta_regulation-implementation_factsheet_en.pdf
https://eur-lex.europa.eu/eli/reg/2021/2282/oj/eng
AESGP OTC News | February 2026 26 | 29
EMA / pharma industry meeting - Official highlights - 19
DEC 2025
The official highlights from the European Medicines Agency (EMA) and pharmaceutical industry
associations meeting on the impact of chemical and environmental policies on the healthcare
sector and availability of medicines on 19 December 2025, have been published on 29 January 2026.
• The link is available here.
The document provides a brief overview of the discussions on key policy files, including the PFAS
restriction under REACH, the Urban Wastewater Treatment Directive (UWWTD), and the Packaging and
Packaging Waste Regulations (PPWR).
Zero Pollution Action Plan - Mid-term review - 29 JAN
2026
The European Commission has released the Mid-term Review of the Zero Pollution Action Plan:
Delivering clean air, freshwater, ocean, and soil on 29 January 2026, building on the scientific evidence
from the second Zero Pollution Monitoring and Outlook 2025. The link to the report is available below:
• Mid-term review of the Zero Pollution Action Plan - Environment
The report sets out ongoing actions the Commission is taking to advance the agenda, while highlighting
the key enablers required to meet those targets and showcasing practical examples and innovative
solutions across Europe. These enablers are as follows:
• Governance and implementation: to drive effective rollout of existing legislation
• Investment: to include public and private funding for pollution reduction
• Integration: to ensure environmental objectives are embedded across all policies
• Innovation: to enable new technologies and cleaner processes
• International cooperation: to reflect the cross-border nature of pollution challenges
For the self-care sector, this mid-term review confirms the focus on pollution prevention at source,
particularly PFAS and other persistent chemicals, continued pressure on implementing recently
updated waste and water legislation, innovation in product and chemical management, and the
importance of cross-sectoral cooperation.
Industry stakeholder webinar on the revised ERA
guideline - EMA summary
Environment
https://www.ema.europa.eu/en/documents/minutes/highlights-meeting-impact-chemical-environmental-policies-healthcare-sector-availability-medicines_en.pdf
https://environment.ec.europa.eu/strategy/zero-pollution-action-plan/zero-pollution-targets_en
https://environment.ec.europa.eu/publications/mid-term-review-zero-pollution-action-plan_en
AESGP OTC News | February 2026 27 | 29
The EMA Summary on main topics discussed at the Second Industry stakeholder webinar on the
revised ERA guideline which took place in October 2025.
European Commission's new cybersecurity package -
Published
On 20 JAN 2026, the European Commission has proposed a new cybersecurity package to further
strengthen the EU's cybersecurity resilience and capabilities in the face of growing threats. This
initiative comes as Europe continues to experience daily cyber and hybrid attacks on essential services
and democratic institutions, carried out by sophisticated state and criminal groups.
The package includes a proposal for a revised Cybersecurity Act, which enhances the security of the
EU's Information and Communication Technologies (ICT) supply chains. It ensures that products reaching
EU citizens are cyber-secure by design through a simpler certification process. It also facilitates
compliance with existing EU cybersecurity rules and reinforces the EU Agency for Cybersecurity (ENISA)
in supporting Member States and the EU in managing cybersecurity threats.
OBJECTIVES OF THE PROPOSED NEW CYBERSECURITY PACKAGE:
• BOLSTERING THE SECURITY OF ICT SUPPLY CHAINS IN THE EU
The new Cybersecurity Act aims to reduce risks in the EU's ICT supply chain from third-country
suppliers with cybersecurity concerns. It sets out a trusted ICT supply chain security framework based
on a harmonised, proportionate and risk-based approach. This will enable the EU and Member States
to jointly identify and mitigate risks across the EU's 18 critical sectors, considering also economic
impacts and market supply.
Recent cybersecurity incidents have highlighted the major risks posed by vulnerabilities in the ICT
supply chains, which are essential to the functioning of critical services and infrastructure. In today's
geopolitical landscape, supply chain security is no longer just about technical product or service
security, but also about risks related to a supplier, particularly dependencies and foreign interference.
The Cybersecurity Act will enable the mandatory derisking of European mobile telecommunications
networks from high-risk third-country suppliers, building on the work already carried out under the 5G
security toolbox.
• SIMPLIFYING AND ENHANCING EUROPEAN CYBERSECURITY CERTIFICATION FRAMEWORK
The revised Cybersecurity Act will ensure that products and services reaching EU consumers are
tested for security in a more efficient way. This will be done through a renewed European
Cybersecurity Certification Framework (ECCF). The ECCF will bring more clarity and simpler
procedures, allowing certification schemes to be developed within 12 months by default. It will also
introduce more agile and transparent governance to better involve stakeholders through public
information and consultation.
Cross-Sectorial
News
https://www.ema.europa.eu/en/documents/report/summary-industry-stakeholder-webinar-revised-guideline-environmental-risk-assessment-medicinal-products-human-use_en.pdf
https://www.ema.europa.eu/en/documents/report/summary-industry-stakeholder-webinar-revised-guideline-environmental-risk-assessment-medicinal-products-human-use_en.pdf
https://ec.europa.eu/commission/presscorner/detail/en/ip_20_123
https://ec.europa.eu/commission/presscorner/detail/en/ip_20_123
AESGP OTC News | February 2026 28 | 29
Certification schemes, managed by ENISA, will become a practical, voluntary tool for businesses.
They will allow businesses to demonstrate compliance with EU legislation, reducing the burden and
costs. Beyond ICT products, services, processes and managed security services, companies and
organisations will be able to certify their cyber posture to meet market needs. Ultimately, the renewed
ECCF will be a competitive asset for EU businesses. For EU citizens, businesses and public
authorities, it will ensure a high level of security and trust in complex ICT supply chains.
• FACILITATING COMPLIANCE WITH CYBERSECURITY RULES
The package introduces measures to simplify compliance with EU cybersecurity rules and risk
management requirements for companies operating in the EU, complementing the single-entry point
for incident reporting proposed in the Digital Omnibus. Targeted amendments to the NIS2
Directive aim to increase legal clarity. They will ease compliance for 28,700 companies, including
6,200 micro and small-sized enterprises. They will also introduce a new category of small mid-cap
enterprises to lower compliance costs for 22,500 companies. The amendments will simplify
jurisdictional rules, streamline the collection of data on ransomware attacks and facilitate the
supervision of cross-border entities with ENISA's reenforced coordinating role.
• EMPOWERING ENISA TO BOOST EUROPE'S CYBERSECURITY RESILIENCE
Since the adoption of the first Cybersecurity Act in 2019, ENISA has grown as a cornerstone of the
EU cybersecurity ecosystem. The revised Cybersecurity Act presented today enables ENISA to help
the EU and its Member States understand the common threats. It also enables them to prepare and
respond to cyber incidents.
The agency will further support companies and stakeholders operating in the EU by issuing early
alerts of cyber threats and incidents. In cooperation with Europol and Computer Security Incident
Response Teams, it will support companies in responding to and recovering from ransomware
attacks. ENISA will also develop a Union approach to provide better vulnerabilities management
services to stakeholders. It will operate the single-entry point for incident reporting proposed in the
Digital Omnibus.
ENISA will continue to play a key role in further building a skilled cybersecurity workforce in Europe.
It will do so by piloting the Cybersecurity Skills Academy and establishing EU-wide cybersecurity skills
attestation schemes.
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_2718
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_2718
https://csirtsnetwork.eu/
https://csirtsnetwork.eu/
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_2718
AESGP — Association of the
European Self-Care Industry
Avenue de Tervuren, 7
1040 Brussels Belgium
info@aesgp.eu
www.aesgp.eu
07.04.2026
Datei
PD
AESGP
Issue 382 | March 2026
Euro OTC News
Table of Contents
MEDICINES _______________________________________________________________________________ 2
Regulatory News _____________________________________________________________________________________________ 2
• 130th EMA Management Board Meeting - 17-18 DEC 2025 - Minutes ______________________________________________ 2
• EMA WS on supporting innovation in cardiovascular medicines and MDs - 1–2 JULY 2026 - For Registration by 13 APR 2026 __ 5
• CMDh Meeting Report - 24-25 FEB 2026 ____________________________________________________________________ 5
• EMA Management Board - MAR 2026 - Meeting highlights ______________________________________________________ 7
• HMA/EMA NDSG workplan 2026 - 2028 - Data and AI in medicines regulation _______________________________________ 8
Pharmacovigilance __________________________________________________________________________________________ 11
• EMA Updated EudraVigilance Documents - Published _________________________________________________________ 11
Herbal medicines ___________________________________________________________________________________________ 12
• HMPWG Meeting report - MAR 2025 & Documents adopted during FEB 2026 HMPWG meeting ________________________ 12
• HMA's HMPWG Draft Points to Consider on Pyrrolizidine Alkaloids in Homeopathic Medicinal Products - For Comments by 25
MAY 2026 ___________________________________________________________________________________________ 13
FOOD __________________________________________________________________________________ 15
Health Claim - EFSA opinion on Anxiofit‐1 and reduction of subthreshold and mild anxiety ______________________________ 15
• Evaluation of a health claim pursuant to article 14 of regulation (EC) No 1924/2006 __________________________________ 15
Health Claims - EFSA opinion on the Oat beta-glucans and reduction of postprandial glucosepeak _______________________ 16
• Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 _______________________________ 16
Article 8 - Plant preparations containing hydroxycitric acid ________________________________________________________ 16
• EFSA Draft Opinion ____________________________________________________________________________________ 16
Article 8 - Plant preparations containing berberine ________________________________________________________________ 17
• EFSA Draft opinion ____________________________________________________________________________________ 17
EFSA _____________________________________________________________________________________________________ 18
• Safety evaluation of blue galdieria extract as a food additive ____________________________________________________ 18
MEDICAL DEVICES _______________________________________________________________________ 19
MDR/IVDR Implementation ____________________________________________________________________________________ 19
• Team-NB Position Paper: Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other
devices or Equipment __________________________________________________________________________________ 19
MDCG International Matters WG - EU-Switzerland agreements ______________________________________________________ 19
• Updated MRA ________________________________________________________________________________________ 19
ENVIRONMENT __________________________________________________________________________ 21
WFD+GWD+EQSD - Council position - 17 FEB 2026 _______________________________________________________________ 21
European Observatory on Health Systems and Policies - Environmental footprint of healthcare facilities - 24 FEB 2026 ______ 22
AESGP OTC News | March 2026
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Regulatory News
130th EMA Management Board Meeting - 17-18
DEC 2025 - Minutes
The minutes from the 130th EMA Management Board meeting held on 17 -18 DEC 2025, have been
published. Among the items reported, the following may be noted:
Report from the European Commission
The Management Board noted an update from the DG SANTE representative on the following files:
revision of the EU pharmaceutical legislation; the Critical Medicines Act; the Biotech Act; the
targeted revision of the Medical Devices Regulations (MDR/IVDR); and the EU Action Plan on
cardiovascular health (EU Safe Hearts Plan).
The political agreement reached on 11 December on the revision of the pharmaceutical legislation
represents a once-in-a-generation revision that, amongst other things, introduces a modulated incentive
system to drive innovation in areas of high societal value, establishes the concept of regulatory sandboxes,
creates a transferable exclusivity voucher to support development of new antimicrobials, strengthens
medicine shortages prevention and notification requirements, and streamlines EMA’s structure while
granting patients and healthcare professionals membership in CHMP. Finalisation and publication of
the new Directive and Regulation are expected in the first half of 2026, followed by a two-year
implementation phase, although some provisions will take effect earlier. The Critical Medicines
Act has completed its passage through the Council and is nearing finalisation in the European Parliament.
The co-legislators are expected to commence trilogue negotiations in January 2026.
The MDR/IVDR revised legal proposal sets-out a streamlined and more predictable regulatory
framework by reducing administrative burden, improving the efficiency of notified body assessments,
introducing more proportionate conformity requirements for lower-risk and special-needs medical devices,
advancing digitalisation, and ensuring better alignment with other EU legislation, such as the AI Act. As
regards the EMA, the revision strengthens the scientific and regulatory role of the medical device expert
panels, assigns the Agency new responsibilities for identifying and facilitating the sharing of information
on shortages of critical medical devices, and supporting coordination of national competent authorities for
medical devices on classification issues, conformity assessment derogations, clinical evaluations and
investigations, as well as some vigilance and market surveillance activities.
The European Parliament representative emphasised that the new legislation will significantly
strengthen efforts against antimicrobial resistance and medicine shortages. He also highlighted the
reform as an important step forward for EMA giving it a more efficient structure aligned with current
realities, welcomed the MDR/IVDR revision in light of changed circumstances since those regulations
were first adopted, and praised the Commission’s strong stance on major public health initiatives, from
the EU Cancer Plan to the new cardiovascular health strategy. He also commented that Member States
should be encouraged to develop national plans for cardiovascular health, following the successful
model used for cancer.
Medicines
https://www.ema.europa.eu/en/documents/minutes/minutes-management-board-meeting-17-18-december-2025_en.pdf
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Preparation for implementation of the new EU pharmaceutical legislation, once adopted
The Management Board endorsed the EMA’s proposal for the New Pharmaceutical Legislation (NPL)
Implementation Governance Structure.
Further to indication at previous Board meetings, the EMA presented a proposed governance model
to steer preparation for implementation of the new pharmaceutical legislation (NPL), noting that the
final text is expected early next year but that preparation must begin immediately. Successful
implementation will require careful coordination given the complexity of the stakeholder landscape, the
impact on virtually all regulatory processes, and the large number of forthcoming implementing and
delegated acts, all within a two-year timeline. To manage this, EMA proposed a clear, adaptive
governance structure, balancing needs for inclusiveness with rapid decision-making. Six delivery streams
were identified: centralised procedures and committee reform; development support;
environmental risk assessment and 3Rs; quality and manufacturing; shortages; and a
miscellaneous legal and regulatory workstream (e.g. looking at definitions, AMR vouchers). Existing
Network working groups, such as scientific working parties, IT governance, and EMA’s stakeholder
engagement groups, would be used to support the implementation rather than creating new ones.
Each delivery stream would be jointly sponsored by an EMA and a Management Board representative,
with civil-society representation added for the centralised procedure. Above these streams, a new NPL
Oversight Group would provide strategic direction, prioritise work, and manage risks, reporting to the
Management Board. The Oversight Group would consist of EMA’s Executive Director and senior
management representatives, Management Board members (including the MB Chair and the HMA Chair),
and a European Commission representative, with Committee Chairs invited when relevant. Next steps
include nominations for delivery stream sponsors and Oversight Group membership, and preparation of
a cross-cutting implementation masterplan mapping responsibilities, timelines and interdependencies
across the legislation.
The DG SANTE representative stressed the importance of discussing governance for the new
pharmaceutical legislation early, noting that implementation will be fast-moving and resource-intensive.
Around 100 delegated/implementing acts will need to be drafted, requiring coordinated effort
across the Commission, EMA and the NCAs’ network.
Board members broadly welcomed EMA’s early planning but underlined challenges relating to
readiness and workload. Several members highlighted that national authorities must absorb multiple
major reforms simultaneously - including the Critical Medicines Act and the Biotech Act - while maintaining
ongoing regulatory responsibilities. They stressed the importance of aligning centralised and decentralised
authorisation procedures (MRP/DCP), ensuring change-readiness, and dedicating adequate resources.
EMA underlined that the reform is a unique opportunity to simplify processes rather than adding new
layers, and that early strategic steering is crucial.
Multiple interventions reinforced the need for a small, agile NPL Oversight Group. Maintaining balanced
representation in the overall governance between larger and smaller Member States and ensuring
geographical diversity were also seen as important. It was emphasised that governance will need to
function across three layers simultaneously – EU, decentralised (MRP/DCP) and national (NCA) level -
making lean structures at EMA essential. A request was made for civil society representation also in the
development-support workstream, given the strong patient involvement in areas such as paediatric and
orphan medicines. The Management Board Chair reminded that the Oversight Group should be seen as
a MB level structure, even if some individuals hold dual roles at EMA/HMA level, underlining that effective
coordination, strategic guidance, and balanced participation is indispensable for the proper functioning of
this governance model. It was also noted that expert input via the delivery streams will be essential.
The Board agreed to proceed with the NPL Oversight Group composition of four EMA senior
managers (including the EMA ED and head of human medicines division), four Management Board
members representing medicines agencies (including the MB chair and HMA chair), and one Commission
representative and with ad-hoc engagement of the chairs of CHMP, PRAC and CMDh when relevant. The
Board also agreed to apply the presented guiding principles (including geographical diversity) in the overall
governance, and to have joint sponsorship of delivery streams by an EMA and a Management Board
representative, with civil-society representation added for the centralised procedure and committees and
for the development-support workstreams. The MB chair invited any interested Board members to contact
him to express interest as a delivery stream sponsor or Oversight Group member.
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New Fee Regulation implementation: update on the time collection data by procedure types in
accordance with Annex VI to Regulation (EU) 2024/568
The Management Board noted an update on the time collection data by procedure types in
accordance with Annex VI to Regulation (EU) 2024/568.
The Board was reminded of the agreed approach adopted at its December 2024 meeting for collecting
time spent by rapporteurs, co-rapporteurs (and equivalent roles), in accordance with the new Fee
Regulation and the related Working Arrangements, for four types of procedures. EMA informed the Board
that the first round of time collection, covering 28 procedures started and completed in the first half of
2025, has been finalised. The information provided by NCAs was reviewed and discussed by the
Management Board sub-group at its October meeting. EMA noted that this exercise is taking place at an
early stage of implementation of the New Fee Regulation and that experience will continue to develop
over time. Variations in time spent across procedures were observed, potentially reflecting differences in
complexity of individual procedures, and EMA indicated that this will be further addressed through
refinements to the reporting template provided to NCAs. The MB sub-group also noted that reporting tools
are still maturing and supported the development of a guidance to support the distinction between scientific
and technical tasks. The next round of data collection is planned for January 2026 to cover the second
half of 2025, for the same types of procedures. In line with the legal requirements of the New Fee
Regulation, aggregated working hours will be published on EMA’s website without identifying individual
Member States.
Report on the data protection activities by EMA in accordance with the EU Data Protection
Regulation
The Management Board endorsed the updated EudraVigilance Joint Controllership Agreement between
EMA, national competent authorities and the European Commission, and noted a report on the data
protection activities of EMA in accordance with the EUDPR.
The Joint Controllership Agreement was updated to reflect the addition of the Signal and Safety
Analytics platform to the EudraVigilance system and to include a dedicated Data Protection Notice
for such platform informing data subjects about the processing of their personal data and their rights under
the EU Data Protection Regulation (EUDPR).
Training remained a key focus. EMA developed new online modules, including general data protection
learning and specialised AI-related courses, available via EU-NTC. Internal guidance was modernised
into short “quick bites” for easier use. Tools supporting compliance with cloud service provider
requirements were also produced. Finally, EMA monitored new EDPS and EU guidance relevant to its
work, including documents on pseudonymisation, IT risk management, AI governance, and changes
introduced to the EUDPR via the Digital Omnibus legal proposal.
DARWIN EU update
The next phase of DARWIN EU will focus on further expanding the network, aligning with the
European Health Data Space and strengthening the use of advanced analytics, including artificial
intelligence. EMA also informed the Board that a competitive tender will be launched in the first half of
2026 for a follow-on “DARWIN EU2” for the period 2027-2032.
During the discussion, Members supported the continued development of DARWIN EU while underlining
the importance of clearly positioning real-world evidence alongside clinical trial data. EMA also clarified
that study timelines depend on data readiness and the complexity of research questions, emphasised the
need for sustained investment in data quality and standards, and confirmed that safeguards are in place
to ensure continuity during the upcoming tender and to further engage NCAs in future use cases.
Update from Network Data Steering Group (NDSG)
An agreement was reached on a proposal for training, including modules on AI, to be rolled out to the
network starting in the first quarter of 2026 through the EU Network Training Centre Learning Management
System. The Board highlighted the importance of data readiness, including SPOR, noting that the
ongoing product master data feasibility work will help inform discussions on resource needs, data
governance and alignment across the network.
AESGP OTC News | March 2026 5 | 23
EMA WS on supporting innovation in
cardiovascular medicines and MDs - 1–2 JULY
2026 - For Registration by 13 APR 2026
In line with the ambitions of the EU Cardiovascular (CV) Health Plan: the Safe Hearts Plan, the European
Medicines Agency (EMA) will host a multi-stakeholder workshop on supporting innovation in
cardiovascular medicines and medical devices in the EU. The workshop will take place on 1–2 JULY
2026 in a hybrid format.
This multistakeholder workshop will bring together patients, healthcare professionals, academia,
regulators, and industry to discuss opportunities to bring together the medicines and devices under the
EMA’s umbrella and leverage the scientific expertise of the Cardiovascular Working Party (CVSWP) and
the Circulatory System medical devices panel in this area.
This workshop will cover interdisciplinary discussions addressing a range of important topics including
clinical gaps, development challenges and regulatory strategies, advancing prevention and
treatment in cardiovascular (CV) diseases in the overlapping fields of diabetes, obesity and lipid
disorders, the role of real-world data, and digitalisation and AI in CV innovation. The overall
objective of the workshop is to enhance understanding among stakeholders on the interplay of
regulation and innovation in medicines and medical devices.
Expected outcomes of the workshop
• Identify priority areas in research and innovation for CV prevention and treatment;
• Improve understanding of scientific and regulatory gaps hindering CV research and innovation;
• Identify strategic recommendations to support development and timely access to safe and effective
medicines and safe and performant medical devices for CV health;
• Provide foundations for follow-up actions, activities and initiatives.
The agenda of the workshop is available here.
CMDh Meeting Report - 24-25 FEB 2026
The report from the CMDh meeting held on 24-25 FEB 2026, has been published. Among the items
reported, the following may be noted:
Summary report on the CMDh Multi-Annual Workplan to 2025
While finalising the new Multi-Annual Workplan (MAWP) to 2028, the CMDh has prepared a summary
report on the previous MAWP to 2025. The report outlines the status and outcomes of the action points
included in the workplan. Where relevant outstanding actions have been taken over in the new MAWP to
2028.
Summary report on the CMDh Multi-annual Workplan to 2025
MRP/DCP statistics in 2025
Statistics on new MRP and DCP applications, extracted from the Communication Tracking System (CTS)
database, will be published on the CMDh website under ‘Statistics".
The statistics also include information on variation worksharing procedures, referrals to the CMDh and
rapporteurships in paediatric worksharing procedures according to Art. 45 and 46 of the Paediatric
Regulation.
MRP/DCP statistics in 2025
https://www.ema.europa.eu/en/events/ema-multi-stakeholder-workshop-supporting-innovation-cardiovascular-medicines-medical-devices-eu
https://www.ema.europa.eu/en/events/ema-multi-stakeholder-workshop-supporting-innovation-cardiovascular-medicines-medical-devices-eu
https://www.ema.europa.eu/en/events/ema-multi-stakeholder-workshop-supporting-innovation-cardiovascular-medicines-medical-devices-eu
https://www.ema.europa.eu/en/documents/agenda/agenda-ema-multi-stakeholder-workshop-supporting-innovation-cardiovascular-medicines-medical-devices-eu_en.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_February_2026.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/About_CMDh/CMDh_Activities/Workplans/CMDh_Multi-annual_Workplan_to_2025_-_Summary_report.pdf
https://www.hma.eu/human-medicines/cmdh/statistics.html
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Statistics/2025_CMDh_Statistics.pdf
AESGP OTC News | March 2026 6 | 23
In addition to the report, please also be informed that the minutes of the CMDh meeting held on 27-28
JAN 2026, have been published. Among the items reported, the following may be noted:
Question and Answers on generic applications
The CMDh discussed a proposal to update the Q&As on Generic Applications to include requirements for
administration via enteral feeding tubes in Q8.b. The update reflects the outcome of the discussion held
in the September 2025 CMDh meeting (topic 4.2.).
Comments from MSs have been taken into account, as appropriate. A final version was agreed and will
be published on the CMDh website.
Experience with complex variation groupings
MSs exchanged experiences in handling of large complex variations, submitted either as large grouped
variations or as single variation applications affecting multiple SmPC sections.
CMDh would like to remind applicants of the importance of clearly describing and supporting proposed
variations changes in line with the Q&A on Variations. While a harmonisation of the product information is
welcome and can be done in worksharing as a single type II C.4 variation, this is based on the fact that
the changes are already approved in at least one MS, and the changes must be accompanied by the
relevant documentation (data) package/justification. In line with Q4.21 a statement should be included in
the eAF clearly highlighting that the variation applied for is a worksharing application for harmonisation of
national product information.
Alternatively, if the proposed changes are new and not a harmonisation, then the requirements of Q4.14
and Q4.17 must be met. Each ‘trigger’ in a variation application results in a single variation which may be
submitted in a grouped application, e.g. one grouped type II variation application of 3 type II variations C.4
and must be clearly explained under the scope and background for change and supported by the relevant
data package. Examples of separate triggers could include: literature investigations, database
investigations, new study results etc. For each of these triggers a single variation is expected.
Furthermore, MAHs should clearly indicate the ‘trigger’/origin of that new information in the clinical
overview and add a comment in the proposed PI submitted for assessment to highlight the relevant trigger
for the amendment.
To elaborate further on the above, when adapting the product information to an updated core company
datasheet (CCDS), each ‘trigger’ for an update in the CCDS should be mentioned in the scope of the
application form and should be classified according to the variation guideline. The identified triggers can
be combined in a grouped variation application.
Adhering to this guidance will improve variation handling and efficiency.
CEP letter of access
The CMDh discussed a question from Medicines for Europe regarding the need to provide a CEP letter of
access (LoA) in case of variations for revisions of the CEP, when the LoA was previously submitted for
older versions of the same CEP.
Some MSs stated that a LoA also needs to be provided with variations for CEP revision, while others
considered that in the above situation the LoA would not need to be submitted again.
There was no majority to drop the requirement to submit a LoA in these cases. The current guidance will
therefore remain in place. The outcome of the discussion will be communicated to IPs.
Medical Device Regulation
The CMDh discussed the requirements for informed consent applications (Art. 10c) of integral drug device
combinations (iDDC), if the MA referred to was submitted prior to 26 May 2021 (i.e. before the Medical
Device Regulation (MDR)) and in compliance with the Medical Device Directive (MDD).
Reference was made to the joint EMA/CMDh Q&A document regarding medicines used in combination
with medical devices and previous CMDh discussions on informed consent applications. It was discussed
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_01_CMDh_Minutes.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2026_01_CMDh_Minutes.pdf
AESGP OTC News | March 2026 7 | 23
in 2015 that it is expected that for an informed consent application, the original MA is updated according
to current legislation. However, it was also agreed that the MDR is not intended to apply retrospectively,
and it was further noted that for an Art. 10c application only Module 1 is expected. Therefore, unless there
are significant changes to the medical device component of the already authorised product, there is no
need to update the dossier in line with the MD Regulation, i.e. to provide a Notified Body opinion.
It was agreed that this approach can be accepted for the specific case of Art. 10c applications, provided
that there are no significant changes in the medical device component. However, the same approach
cannot be extrapolated to e.g. duplicate applications under other legal basis.
Caffeine / codeine / paracetamol / propyphenazone, acetylsalicylic acid / caffeine / codeine /
paracetamol - PSUSA/00002312/202506
(Subject to adoption via written procedure in advance of the meeting.)
The CMDh, having considered the PSUR on the basis of the PRAC recommendation and the PRAC
assessment report, agreed by consensus on the variation of the marketing authorisations of medicinal
products containing caffeine / codeine / paracetamol / propyphenazone, acetylsalicylic acid /
caffeine / codeine / paracetamol.
Besides other changes, the PRAC concluded during the PSUSA that the drug-drug interaction with
gabapentinoids (gabapentin and pregabalin) should be added to the SmPC and PL of products containing
caffeine / codeine / paracetamol / propyphenazone, acetylsalicylic acid / caffeine / codeine / paracetamol.
Environmental Risk Assessment (ERA)
The CMDh discussed the acceptability/refusal of ERA Phase II data from other products than the one in
the MAA, in order to prevent repetition of (animal) studies and to avoid duplication of unnecessary work
both for applicants and NCAs.
Several MSs replied that in a generic application they allow the use of conclusions of data from the RefMP,
if this is published, even if the applicant does not have a letter of access.
IT was asked to prepare an overview of the feedback received from MSs in order to identify the
discrepancies and to agree on a harmonised approach. MSs that have not yet replied, were encouraged
to do so. The topic will be discussed again in February.
In the meantime, IT will follow the approach of the majority of received responses and allow the use of
conclusions of Phase II data from other products in their national MAA.
EMA Management Board - MAR 2026 - Meeting
highlights
The highlights of the EMA Management Board MAR 2026 meeting, have been published. Among the
items reported, the following may be noted:
EMA annual report 2025
The Management Board adopted EMA’s annual report for 2025, marking another strong year for medicines
regulation in the European Union. The report highlights key steps taken to optimise medicines
assessments, improve access and strengthen medicines availability across the EU. It also outlines EMA’s
role in implementing the Health Technology Assessment Regulation, coordinating actions to prevent and
mitigate shortages and reinforcing the resilience of the EU medicines regulatory network.
The report, including an interactive digital version, will be published in May 2026.
Preparations for implementation of the new EU pharmaceutical legislation
The Board was updated that the new EU pharmaceutical legislation implementation governance structure
is largely in place for EMA and the network, with leads nominated for the workstreams and all EMA and
https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2026-meeting
AESGP OTC News | March 2026 8 | 23
Management Board sponsors confirmed. The governance structure reflects the necessary joint work on
the new legislation by the European Commission, EMA and the EU national competent authorities.
Once the texts have been formally adopted by the Council and the European Parliament, the European
Commission will develop a series of delegated and implementing acts with further details on the new
requirements and procedures. In addition, EMA will develop guidance to support applicants and marketing
authorisation holders in understanding and complying with the new legal framework.
Electronic product information implementation roadmap
The Board noted the draft roadmap for a coordinated roll-out of electronic product information (ePI) for
human medicines across the EU medicines regulatory network. The ePI initiative will improve the timely
delivery of up-to-date, accurate and accessible information on EU medicines to patients and healthcare
professionals.
Once the new EU pharmaceutical legislation enters into application, ePI will become mandatory for all
newly authorised medicines. The roadmap will be communicated to stakeholders and published on the
EMA website in the coming weeks.
EMA reports on stakeholder engagement activities 2024-2025
EMA’s report on stakeholder engagement over the last two years was presented to the Board. The report
describes activities involving the Agency’s key stakeholder groups, including patient and consumer
organisations, healthcare professional organisations, academia and EU industry organisations.
Throughout 2024 and 2025, stakeholders continued to contribute to the Agency’s core business of
evaluating medicines and monitoring their safety. In addition, stakeholders have contributed to shaping
the future of the European pharmaceutical environment by taking part in several initiatives including
the European Medicines Agencies Network Strategy to 2028, the ethical and effective use of artificial
intelligence and digitalisation tools, and the reflection paper on patient experience data. Engagement with
academia and industry was also reinforced through dedicated platforms and strategic dialogue. The report
will be published on the EMA website.
Impact of war in the Middle East
The Board heard that EMA, along with the Medicine Shortages Single Point of Contact (SPOC) Working
Party, under the governance of Executive Steering Group on Shortages and Safety of Medicinal
Products (MSSG), is monitoring the impact of the war in the Middle East on the supply of medicines in the
EU very closely with a view to identifying appropriate mitigation measures, where necessary.
To date, there are no reports of current critical shortages of medicines, however, companies are reporting
various levels of disruptions, mostly related to interruptions to air freight and maritime routes, and rising
costs. The situation is highly dynamic, and the risk of shortages may increase if disruptions persist.
HMA/EMA NDSG workplan 2026 - 2028 - Data
and AI in medicines regulation
The EMA has published the updated HMA/EMA Network Data Steering Group (NDSG) Workplan
2026–2028: Data and AI in medicines regulation, which makes a major contribution to the
implementation of the EMAN Strategy to 2028 by leveraging data, digitalisation, and AI (Theme 2),
while also supporting its other strategic themes, with a vision to unlock the value of data to deliver
trusted medicines.
The first NDSG workplan was adopted in March 2025. This current document constitutes the first annual
revision. It introduces the NDSG workplan, covering activities whose scope spans both human and
veterinary medicines until 2028. It was adopted by NDSG in February 2026 and will be updated annually,
informed by feedback from stakeholders and EU network experts.
Below you will find a brief overview of the main elements of the workplan :
https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-medicines-agencies-network-strategy#network-strategy-to-2028-70501
https://www.ema.europa.eu/en/documents/other/network-data-steering-group-workplan-2026-2028-data-artificial-intelligence-medicines-regulation_en.pdf
https://www.ema.europa.eu/en/documents/other/network-data-steering-group-workplan-2026-2028-data-artificial-intelligence-medicines-regulation_en.pdf
https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-medicines-agencies-network-strategy
https://www.ema.europa.eu/en/documents/other/network-data-steering-group-workplan-2026-2028-data-artificial-intelligence-medicines-regulation_en.pdf
AESGP OTC News | March 2026 9 | 23
Six key workstreams
1. Strategy & governance,
2. Data analytics,
3. Artificial intelligence,
4. Data interoperability,
5. Stakeholder engagement & change management,
6. Guidance & international initiatives.
1. Strategy & governance
A coordinated strategic approach will be central across the network, supporting the European medicines
regulatory network (EMRN) data strategy and the publication of the data standardisation and data
analytics frameworks to ensure that data assets meet high-quality standards, are properly managed,
standardised, easily shareable, and able to maximise their utility. NDSG will conduct horizon scanning
and monitor progress in EU-level regulatory science research projects related to data. This will enable the
group to stay aligned with advances in data and digital tools and to make informed
recommendations on future network priorities and engagement.
NDSG will be contribute to the implementation of key EU legislative initiatives that will be implemented
over the coming years. This includes the revised EU pharmaceutical legislation (advice on
RWD, clinical study data, Annex 1 revision, environmental risk assessment, OneHealth, ePI), The
European Health Data Space (EHDS), its joint action TEHDAS2 and its related implementation projects,
the Interoperable Europe Act and the related European Interoperability Framework. NDSG will also
discuss progress in forthcoming European Biotech Act and its implications and opportunities on data.
Additional area of focus may include the Medical Device regulation, the Data Union strategy, and the
EU digital omnibus, ensuring the Network remains aligned with the evolving EU policy landscape.
2. Data Analytics
The NDSG will review innovative methodologies (including biostatistics, signal detection, modelling &
simulation data, AI and pharmacoepidemiology) and data types that can complement established
clinical data (e.g. genomic data, synthetic data, digital twins data, patient experience data (PED), mobile
health data and social media data) for evidence generation to enable regulatory decision-making.
Activities related to the EMRN’s federated network, DARWIN EU will continue to enable access and
analysis of RWD. This includes yearly conduct of increasing numbers of studies and onboarding of
additional data partners. Following an open tender in 2026, DARWIN EU 2 will be launched in 2027, as
an extension of DARWIN EU. The NDSG will continue to support the NCA’s initiatives on real-world
evidence (RWE).
In addition, leveraging clinical study, non-clinical, EudraVigilance, and genomic data will be central
to improving quality and efficiency while strengthening regulatory decision-making. This includes the
transition of the CHMP clinical study data pilot to the systematic submission of clinical study data for
CAPs, enabling the pilot results to inform the EMRN on the optimal approach for rolling out clinical study
data analysis and managing changes, the publication of a report on the Proof of Concept (PoC) for non-
clinical data analysis to evaluate the implementation of the Standard for Exchange of Nonclinical Data
(SEND) in 2025, the continuation of voluntary SEND data submissions by MAHs, and the preparation of
the EMRN for wider-uptake. Regarding EudraVigilance data, improved (human) pharmacovigilance
signal detection capabilities for authorised products, as well as new screening capabilities for clinical
trial Suspected Unexpected Serious Adverse Reaction reports (SUSAR), will be deliveredto EMRN
assessors, MAHs and the general public.
3. Artificial Intelligence
This plan, which will be updated regularly in light of technological, regulatory and scientific developments,
focuses on three critical dimensions to facilitate the development and use of safe and responsible
AI across human and veterinary medicines, by including an ethical dimension across all deliverables,
and by focusing on enabling the development of beneficial AI that delivers for public and animal health.
As part of the NDSG’s guidance, policy, and product support goals, continued support will be provided
for the development and evaluation of AI throughout the medicines lifecycle. Support will also be given to
EMA Scientific Committees in delivering their AI-related activities, including work on AI literacy,
development of AI tools, and the preparation of guidance. A coordinated roadmap for future AI-related
https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en
https://tehdas.eu/
https://commission.europa.eu/publications/interoperable-europe-act_en
https://op.europa.eu/en/publication-detail/-/publication/f69284c4-eacb-11eb-93a8-01aa75ed71a1/language-en
https://www.ema.europa.eu/en/about-us/how-we-work/big-data/real-world-evidence/data-analysis-real-world-interrogation-network-darwin-eu
AESGP OTC News | March 2026 10 | 23
guidance, aligned with the proposed Biotech Act, and guiding principles on responsible AI and an
accompanying terminology document including mapping of glossaries will be developed.
Regarding the implementation of tools and support for innovation, core AI capabilities will continue to
be strengthened, and new collaborative approaches will be piloted across the Network such as
EMRN Prompt Community pilot, several existing AI solutions will be further supported and expanded
to deploy new tools including SPC Reader and additional AI assistants, AI research priorities will be
published and subsequently revised to incorporate new developments and emerging needs, the AI Tools
Framework will be implemented in late 2026 to foster collaboration and sharing of AI tools. In parallel,
IncreaseNet’s initiative to promote cross-network sharing of AI solutions will be supported and will
inform the 2028 update of the AI Tools Framework.
The AI Special Interest Area will collaborate with IncreaseNet to support a growing AI community of
practice and extend knowledge sharing to a broader range of staff, while AI literacy training will be rolled
out across the EMRN. The Network will continue to collaborate closely with international and
European partners. Through topic-to specific public workshops, masterclasses and hackathons
including AI Sandbox Simulation Hackathon to explore challenges and regulatory considerations in
hypothetical AI use-case scenarios, stakeholder communications and engagement on AI will be
fostered.
4. Data interoperability
Data-asset discovery, cataloguing and metadata management, data-quality management, and both
organisational and semantic interoperability form the key pillars of this workstream. Accordingly, a
comprehensive approach to data cataloguing and metadata management for the Network critical
data assets will be developed and rolled-out. After the launch of the EMA-HMA catalogues of real-world
data sources and non-interventional studies, integration with the veterinary domain and interface with
the EHDS data catalogue will be explored. A data quality approach will be developed, informed by and
aligned with the relevant EU data quality initiatives, notably the data quality framework for EU medicines
regulation. Specific quality chapters for selected data domains, starting with Real-world data (RWD),
Adverse Drug Reaction (ADR), and Product Master System (PMS) data will be published, together
with data-quality maturity assessments to ensure that the quality of the Network’s critical data assets
is well understood.
NDSG will work to progress, harmonise and support the implementation of PMS system through
Network portfolio and HMA Regulatory Optimisation Group (ROG) as common source of product master
data for all EU medicinal products supporting EU wide use cases. Additional PMS master data will be
made available to stakeholders via the launch of a public API. More generally, the NDSG will promote API
first architecture for the development of the Network tools. NDSG will also discuss recommendations
for substance master data in the SMS and EU-SRS systems as well as provide continuous support
and advice to the EMRN for the development and implementation of international data standards
(e.g. HL7, ISO, ICH…) for the ERMN, in line with Data Standardisation Framework.
5. Stakeholder engagement and change management
NDSG will oversee the implementation of the Network change management plans (on data) to
ensure effective communication, engagement and knowledge-building for high-priority topics, such as
real-world evidence, artificial intelligence, clinical study data analysis and Product Master System (PMS)
data. Training programs (covering at least biostatistics, pharmacoepidemiology/real world evidence,
data science, pharmacogenomic, AI and data protection) will be rolled out to the Network and relevant
stakeholders when appropriate via the EU Network Training Centre (EU NTC) and in collaboration with
the IncreaseNet programme.
A multi-stakeholder forum on data will be organised annually and will be complemented by specialised
workshops (e.g. AI, registries, Patient Experience Data, signal detection and PMS) and workshops
supported by the EMA Methodology Working Party (MWP) held throughout the period of this workplan.
Interaction with industry will be organised through groups focused on RWE, clinical study data,
and AI, and, in collaboration with the Regulatory Optimisation Group (ROG) on master data.
7. Guidance & international initiatives
The CHMP Methodology Working Party (MWP) is responsible for the drafting of methodology guidance
and to support their implementation. Activities referred in the NDSG workplan follow the workplan of the
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf
https://www.hma.eu/about-hma/working-groups/regulatory-optimisation-group-rog.html
https://www.ema.europa.eu/en/documents/other/consolidated-3-year-rolling-work-plan-methodology-working-party-2025-2027_en.pdf
AESGP OTC News | March 2026 11 | 23
CHMP MWP for the development of guidance (e.g. reflection paper, concept paper and Q&A) across data
and methods including methodological ICH guidelines.
NDSG will facilitate stakeholder engagement and listen to their needs and support implementation of
international consensus guidelines and standards. The Network collaboration at ICH will continue
and progress will be made on implementation at EU level when relevant. International collaboration on
RWE will continue throughout the workplan under the umbrella of ICMRA and its working group on RWE
for Public Health Emergencies.
The document includes key dates for the activities under each workstream. The details are available
here.
Pharmacovigilance
EMA Updated EudraVigilance Documents -
Published
The following number of EudraVigilance-related documents have been updated on the European
Medicines Agency (EMA) website:
• Electronic reporting to EudraVigilance - List of reference documents
• EudraVigilance - EVWEB User Manual Version 1.11
• EudraVigilance support guide
1) Electronic reporting to EudraVigilance - List of reference documents
This document is a central reference hub, providing a consolidated, authoritative list of of all technical
and regulatory documents needed for electronic pharmacovigilance reporting to EudraVigilance,
including standards, implementation guides, terminology requirements, and change management
materials, among others.
2) EudraVigilance - EVWEB User Manual Version 1.11 (the revised document has also been provided
in the above consolidated reference list)
This official operational guidance document from the EMA is a user manual consisting of five chapters
designed to support the use of the EudraVigilance Web reporting tool (EVWEB). It provides an
overview of EudraVigilance and EVWEB, together with the relevant standards (e.g., ICH E2B(R3)), and
explains the role of EVWEB within the system. The manual includes step-by-step guidance on how to
use EVWEB functions and how to work with Individual Case Safety Reports (ICSRs). It also describes
the integration of MedDRA within the system, provides insight into the administrative tools available
in EVWEB, and lists the abbreviations and acronyms introduced in the manual along with their
respective descriptions.
In addition to the introduction of updates in several sections, please note that the following new sections
have been added:
• 1.5.2. Unavailability of the EVWEB application / What to do in case of system failure
• 1.8. Masking of personal data in ICSRs/SUSARs submitted to EudraVigilance
• 2.6.1.4.1. Searching for units in Immediate Query Fields
• 3.2.1. Tests and Procedures
• 3.5.2.3. Viewing the EMA’s official receipt date (gateway date) in EVWEB
• 3.5.2.3.1. Reporting compliance calculation
3) EudraVigilance support guide (the revised document has also been provided in the above
consolidated reference list)
https://www.ema.europa.eu/en/documents/other/consolidated-3-year-rolling-work-plan-methodology-working-party-2025-2027_en.pdf
https://www.ema.europa.eu/en/documents/other/network-data-steering-group-workplan-2026-2028-data-artificial-intelligence-medicines-regulation_en.pdf
https://www.ema.europa.eu/en/documents/other/electronic-reporting-eudravigilance-list-reference-documents_en.pdf
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-evweb-user-manual_en.pdf
https://www.ema.europa.eu/en/documents/other/eudravigilance_support_page_detailed_guidance_en.pdf
https://www.ema.europa.eu/en/documents/other/electronic-reporting-eudravigilance-list-reference-documents_en.pdf
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-evweb-user-manual_en.pdf
https://www.ema.europa.eu/en/documents/other/eudravigilance_support_page_detailed_guidance_en.pdf
AESGP OTC News | March 2026 12 | 23
This guidance document is a practical operational support guide published by the EMA to assist
stakeholders (marketing authorisation holders (MAHs), sponsors of clinical trials, and national competent
authorities) with EudraVigilance- and Pharmacovigilance-related queries and support
procedures. The document explains how to access support services, log requests effectively, and
communicate issues or questions to the EMA’s Service Desk in a structured, efficient way.
At the end of the document, EMA provides additional sources of information on:
• EudraVigilance (EV)
• EV registration
• SUSARs (Suspected Unexpected Serious Adverse Reactions)
• ICSRs (Individual Case Safety Reports)
• MLM (Medical Literature Monitoring)
Herbal medicines
HMPWG Meeting report - MAR 2025 &
Documents adopted during FEB 2026 HMPWG
meeting
The Heads of Medicines Agencies’ Homeopathic Medicinal Products Working Group (HMPWG)
published the report from its 40th meeting held in MAR 2025 in a virtual format.
The following topics have been discussed:
Safety
The sub-working group First Safe Dilution (s-WG FSD) was reactivated and a kick-off meeting was
organised in March 2025, which gathered experts FSD and HMPWG (secretariat) members.
Minutes of the kick-off meeting were presented. More specifically, a previously HMPWG-adopted list of
stocks for which an FSD could be defined will serve as basis to experts for further assessment of FSD.
Minutes of the kick-off meeting were subsequently adopted by HMPWG.
Homeopathic use
The finalized documents: OoC – List of nosodes for which homeopathic use is justified, Preamble to the
list of nosodes for which justification of homeopathic use cannot be established due to a lack of data and
List of nosodes for which justification of homeopathic use cannot be established due to a lack of data were
adopted and sent to the HMA for publication.
The document Update of the consolidated list of stocks for which homeopathic use is justified was updated
and HMPWG members were invited to send comments until 30th April 2025.
Quality
The chairperson of the s-WG on quality summarized the activities since the last HMPWG meeting.
The finalized documents OoC Guidance on module 3 and Guidance on module 3 were adopted and sent
to the HMA for publication.
The work on the document Points to Consider on Pyrrolizidine alkaloids in Homeopathic MPs is ongoing.
Legislation
SoHO Regulation
https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/2026_03_Public_Report_HMPWG_40th_Warsaw_final.pdf
AESGP OTC News | March 2026 13 | 23
The EMA representative informed that the SoHO regulation applies to the homeopathic medicinal products
but is limited to the activities indicated in Article 2.6. The legal department of BfArM confirmed the
statement that the homeopathic MPs were not excluded from SoHO regulation.
Status module 1.2 Homeopathic Application form
All HMPWG members agreed that Article 14 may be included in the electronic Application Form (eAF). It
is still under discussion if Articles 16.1 and 16.2 should be included in the eAF.
National Information
The Finnish HMPWG member presented the “Q&A proposals for Bach Flower Remedies and Cell Mineral
Products”. HMPWG members were invited to send comments until 30th June 2025.
In addition, the following guidance documents adopted by HMPWG during their meeting in FEB
2026 have been published:
• Consolidated list of stocks for which homeopathic use is justified_rev.1
This is a revised final comprehensive document of the previous adopted lists 1-6, sorted
alphabetically by the GHP/German traditional name of the stock.
• Consolidated list of stocks for which homeopathic use is justified_rev.1
This is a revised final comprehensive document of the previous adopted lists 1-6, sorted
alphabetically by the FP/French traditional name of the stock.
HMA's HMPWG Draft Points to Consider on
Pyrrolizidine Alkaloids in Homeopathic Medicinal
Products - For Comments by 25 MAY 2026
The Heads of Medicines Agencies’ Homeopathic Medicinal Products Working Group (HMPWG)
has published a new guidance document related to the quality of homeopathic medicinal
products. The document is now available for public consultation until 8 JUN 2026, following its
adoption for publication by consensus at the 41st HMPWG meeting held under the Cypriot Presidency.
This guidance document is intended to provide a harmonized approach on the evaluation of the
content of pyrrolizidine alkaloids in homeopathic medicinal products of herbal origin and to provide
guidance on the information to be included in an application dossier for homeopathic medicinal
products. This document is applicable to the registration of homeopathic medicinal products under
the simplified procedure (article 14) as well as for authorization of homeopathic medicinal products
(article 16), on a national level.
The proposed draft guidance document has been developed as it is necessary to collect data on the
content of toxic pyrrolizidine alkaloids of mother tinctures prepared from plants which
biosynthesize PAs (e.g. species of the genera Symphytum, Eupatorium, Senecio, Jacobaea, Petasites,
Tussilago, Cynoglossum). Considering PAs as contaminants of herbal material used for the preparation
of homeopathic medicinal products, requirements on pharmaceutical product quality, as defined by
Good Manufacturing Practices (GMP)/ Good Agricultural and Collection Practices (GACP) should
prevent PA-contamination of plant material used for homeopathic medicinal products as far as
possible. However, toxicologically relevant concentrations of pyrrolizidine alkaloids may result from
contamination with very few plants. Thus, appropriate control cannot be based on GACP-related
actions only but testing of homeopathic preparations may also be necessary.
Recommendations
Among the recommendations provided throughout the document to address the issues described above,
the following may be noted:
• A product specific risk evaluation is possible for homeopathic medicinal products.
• Two decision trees have been developed that may support the assessment of whether routine
PA testing is necessary. The decision tree #1 (Figure 1) is applicable to PA-biosynthesizing plants
https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/HU_rev_consolidated_list_de_1-6_February_2026.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/HU_rev_consolidated_list_fr_1-6_February_2026.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/202602_Draft_Points_to_consider_on__PA_26022026.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/202602_Draft_Points_to_consider_on__PA_26022026.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/HMPWG/202602_Draft_Points_to_consider_on__PA_26022026.pdf
AESGP OTC News | March 2026 14 | 23
and the decision tree #2 (Figure 2) is applicable in case of possible contamination of plant material
with PAs.
• The potential presence of PAs in homeopathic medicinal products containing mother tinctures
should be assessed in the same way as it is for herbal medicinal products.
• Among the parameters taken into account for risk evaluation or setting of specification limits, the
content of PAs in the mother tincture, the final dilution of the homeopathic medicinal
product, the age of the target patient groups, and the bodyweight, especially in children, are
the most relevant.
• In case of combination products, the impact of all ingredients of herbal origin must be
considered.
• Recommendations have also been made on acceptable limits for PAs in herbal medicinal
products for adults, including pregnant and breastfeeding women, as well as for children and
adolescents. These recommendations also address testing stages and conditions for the
mother tincture, intermediate preparations, or the finished product, as well as threshold levels
and examples of calculations.
AESGP OTC News | March 2026 15 | 23
Health Claim - EFSA opinion on Anxiofit‐1 and reduction
of subthreshold and mild anxiety
Evaluation of a health claim pursuant to article 14
of regulation (EC) No 1924/2006
EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has published its opinion on Anxiofit‐
1 and reduction of subthreshold and mild anxiety: Evaluation of a health claim pursuant to article 14 of
regulation (EC) No 1924/2006.
According to the applicant, the target population for the claimed effect is “those having sub-threshold and
mild anxiety symptoms but who are otherwise healthy”. In the original dossier, this population was defined
as individuals aged 1 year and older. Upon EFSA’s request for clarification, the applicant revised the age
range to individuals aged 7 years and older.
The recommended daily intake proposed by the applicant is 40–80 mg. In the context of the revised target
population (individuals aged 7 years and older), the applicant proposed a daily intake of approximately 40
mg for children, corresponding to 50% of the upper end of the adult dose range.
The recommended dosing duration is at least 7–14 consecutive days.
On the basis of the data presented, the Panel concludes that:
• The food/constituent, Anxiofit-1, an Echinacea angustifolia root extract standardised for the
content of echinacoside (at least 3%) and the profile of alkamides, which is the subject of the
health claim, is sufficiently characterised.
• The claimed effect proposed by the applicant is the reduction of subthreshold and mild anxiety
symptoms. The target population proposed by the applicant is “those having subthreshold and
mild anxiety symptoms but who are otherwise healthy” and includes individuals aged 7 years and
older. The reduction of subthreshold and mild anxiety is considered a beneficial physiological
effect. Subthreshold and mild anxiety are risk factors for anxiety and depressive disorders.
• The scientific evidence is insufficient to establish a cause-and-effect relationship between
the consumption of Anxiofit-1 and the reduction of subthreshold and mild anxiety as risk factors
for anxiety and depressive disorders.
Food
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9964
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9964
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9964
AESGP OTC News | March 2026 16 | 23
Health Claims - EFSA opinion on the Oat beta-glucans
and reduction of postprandial glucosepeak
Evaluation of a health claim pursuant to Article
13(5) of Regulation (EC) No 1924/2006
EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has published its opinion on Oat beta-
glucans and reduction of postprandial glucose peak: Evaluation of a health claim pursuant to Article 13(5)
of Regulation (EC) No 1924/2006.
According to the applicant, the target population for the intended health claim is individuals who wish to
reduce their postprandial glucose peaks.
The applicant proposed that 1.9 g of oat beta-glucans (OBG) per 30 g of available carbohydrates
(availCHO) should be consumed per meal. The claimed effect may be used for all food products that
contain all forms of beta-glucans derived from oats, including those present naturally in oat products and
products containing added beta-glucan extracts derived from oats, provided that the OBG-to-availCHO
ratio in the final product, as regularly consumed, meets or exceeds the proposed ratio of 1.9 g of OBG
per 30 g of availCHO.
Following an additional data request (ADR) by EFSA, and considering the revised claimed effect, the
applicant proposed that 1.2 g of oat beta-glucans (OBG) per 30 g of available carbohydrates (avCHO)
should be consumed per meal.
On the basis of the data presented, the Panel concludes that:
• The food/constituent, oat beta-glucans, which is the subject of the health claim, is sufficiently
characterised.
• The claimed effect is the reduction of postprandial blood glucose peaks, which is considered
a beneficial physiological effect.
• A cause-and-effect relationship has been established between the consumption of oat
beta-glucans (OBG) and the reduction of postprandial blood glucose peaks.
• The following wording reflects the scientific evidence:
“Consumption of beta-glucans from oats contributes to the reduction of the glucose peak after a
meal.”
• In order to bear the claim, foods or meals should contain at least 30 g of available
carbohydrates per portion and at least 3 g of beta-glucans from oats for each 30 g of
available carbohydrates. The target population is individuals who wish to reduce their
postprandial glucose peaks.
Article 8 - Plant preparations containing hydroxycitric
acid
EFSA Draft Opinion
EFSA's Nutrition and Food Innovation Unit has published for public consultation the Draft
scientific opinion on the safety of hydroxycitric acid and plant preparations containing
hydroxycitric acid in the context of the procedure initiated by the European Commission under Article 8
(2) of Regulation (EC) No 1925/2006.
The Spanish authorities have raised concerns regarding a potential risk to consumers linked with the
consumption of foods containing the pericarp of the fruit of Garcinia gummi-gutta (L.) Roxb. (syn. Garcinia
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9942
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9942
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9942
https://open.efsa.europa.eu/consultations/a0cTk00000SKe9XIAT
https://open.efsa.europa.eu/consultations/a0cTk00000SKe9XIAT
https://open.efsa.europa.eu/consultations/a0cTk00000SKe9XIAT
AESGP OTC News | March 2026 17 | 23
cambogia (Gaertn.) Desr.) on the basis of a risk assessment conducted by the Spanish Agency for Food
Safety and Nutrition (AESAN).
The AESAN risk assessment report refers to the use of the pericarp of the fruit containing hydroxycitric
acid (HCA) which is responsible for the anti-obesity properties attributed to Garcinia gummi-gutta. The
report concludes that there is sufficient clinical evidence to establish a causal association between the
consumption of Garcinia gummi-gutta and the duration of treatment, as well as the development of acute
liver injury, with a clear improvement in liver function after stopping the consumption of the Garcinia
gummi-gutta food supplement.
Consequently, the Commission has initiated the procedure under Article 8 (2) of Regulation (EC) No
1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, for the
mentioned plant preparations containing HCA and for isolated HCA.
In the draft opinion the NDA Panel Concludes that:
• the available data are insufficient to confirm or exclude genotoxicity of (+)-allo-HCA or H.
sabdariffa calyx/petal preparations; H. sabdariffa preparations may exert transplacental
genotoxicity but this needs to be confirmed in an additional study;
• H. sabdariffa calyx/petal preparations induced testicular, kidney and liver toxicity in experimental
rodent studies; concerns for a delayed onset in puberty of female rats following transplacental
exposure also exist;
• testicular toxicity has been observed with an infusion at a dose of 200 mg/kg bw per day of calyx
equivalents in mice; however, the evidence is insufficient to identify a NOAEL; a dose which is
associated with kidney and liver toxicity can also not be identified;
• the currently available data are insufficient to establish a safe intake for humans for (+)-
allo-HCA or H. sabdariffa calyx/petal preparations.
Article 8 - Plant preparations containing berberine
EFSA Draft opinion
EFSA's Nutrition and Food Innovation Unit has published for public consultation the Draft
scientific opinion on the safety of plant preparations containing berberine in the context of the
procedure initiated by the European Commission under Article 8 (2) of Regulation (EC) No 1925/2006 on
the addition of vitamins and minerals and of certain other substances to foods.
The French authorities have raised concerns regarding a potential risk to consumers linked with the
consumption of plant preparations containing the isoquinoline alkaloid berberine. These concerns are
outlined in an opinion by the French Agency for Food, Environmental and Occupational Health & Safety
(ANSES) on the risks associated with the use of berberine-containing plants as ingredient in food
supplements.
The European Commission has therefore tasked EFSA to:
• Review the existing scientific data on the possible link between the intake of preparations of the
following berberine-containing plant parts and an adverse effect on health:
Berberis aquifolium Pursh (root), Berberis aristata DC (root, bark), Berberis vulgaris L. (root,
bark), Chelidonium majus L. (herb), Coptis japonica (Thunb.) Makino (rhizome), Coptis teeta
Wall. (rhizome), Coptis trifolia (L.) Salisb. (rhizome), Coscinium fenestratum (Goetgh.) Colebr.
(root, stem), Hydrastis canadensis L. (rhizome), Jateorhiza palmata (Lam.) Miers (root),
Phellodendron amurense Rupr. (bark), Thalictrum flavum L. (root), Tinospora sinensis (Lour.)
Merr. (root, stem, leaf).
• Provide advice on a daily intake of the plant preparations containing berberine that does not give rise
to concerns about adverse effects to health for the general population, and as appropriate, for
vulnerable subgroups of the population.
In the draft opinion the NDA Panel concludes that:
• The consumption of berberine-containing food supplements may lead to transient gastrointestinal
symptoms such as constipation, diarrhoea, nausea, and abdominal pain.
https://open.efsa.europa.eu/consultations/a0cTk00000SHN5JIAX
https://open.efsa.europa.eu/consultations/a0cTk00000SHN5JIAX
AESGP OTC News | March 2026 18 | 23
• Berberine may inhibit CYP3A4 and possibly other CYP450 enzymes, indicating a risk for
interaction between berberine-containing plant preparations and various medicinal products.
• In humans, consumption of preparations of C. majus aerial parts has been linked to idiosyncratic
herb-induced liver injury; susceptible individuals cannot currently be identified, nor can a dose be
established below which such reactions would not occur.
• The available data do not allow establishing a safe intake for humans for any preparations
of the plant species, and plant parts thereof, included in the assessment.
EFSA
Safety evaluation of blue galdieria extract as a
food additive
The EFSA Panel on Food Additive and Flavourings (FAF Panel) has recently published its safety
evaluation of blue galdieria extract as a food additive.
Blue galdieria extract is an enzymatically treated C‐phycocyanin extract derived from the lysed biomass
of the microalgae Galdieria sulphuraria. The extract is mainly composed of C‐phycocyanin (over 25%),
along with other proteins, carbohydrates and dietary fibres. Information and studies provided showed that
its components, including the chromophore phycocyanobilin, were metabolised like normal dietary
constituents and with a similar fate and efficiency as bile pigments.
The Panel concluded that there is no safety concern for blue galdieria extract as a food additive at
the proposed uses and typical use levels. The Panel could not conclude on the safety for the
proposed uses at quantum satis as a Group II food additive due to the absence of use levels to
estimate the resulting exposure.
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9960
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9960
AESGP OTC News | March 2026 19 | 23
MDR/IVDR Implementation
Team-NB Position Paper: Demonstration of Safety
and Performance for Combinatorial Use of
Reagent Devices with other devices or Equipment
Team-NB has published a Position Paper on the Demonstration of Safety and Performance for
Combinational Use of Reagent Devices with other devices or Equipment. This paper serves as a
supporting guidance to the “Team-NB Position Paper: Best Practice Guidance for the Submission of
Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU)
2017/746”
Under Regulation [IVDR] (EU) 2017/746, manufacturers must ensure the safety and performance of
devices used in combination with other devices or instruments. While the regulation does not define
explicit rules for validating combinatorial claims, notified bodies expect clear, robust, and reproducible
evidence supporting these claims. The guidance aims to provide harmonised Notified Bodies expectations
concerning the demonstration of safety and performance for reagent devices intended to be used in
combination with other devices or equipment/instruments. It advises manufacturers to prioritise
comprehensive validation, risk mitigation, and transparency in labelling and IFU to align with these
expectations.
MDCG International Matters WG - EU-Switzerland
agreements
Updated MRA
On 2 March 2026, the President of the European Commission Ursula von der Leyen and the President of
the Swiss Confederation Guy Parmelin signed a broad package of agreements aiming to deepen and
expand the EU-Switzerland relationship. The package updates several existing agreements, including the
Mutual Recognition Agreement (MRA) covering the medical devices sector.
The amending protocol to the MRA requires products certified in one market to be accepted in the other
without duplicative procedures.
The updated Agreement will enter into force alongside the broader package once both sides have
completed their respective ratification procedures. Until then, the current framework remains unchanged.
Medical
Devices
https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-PositionPaper-Demonstration-of-Safety-and-Performance-for-Combinatorial-Use-of-Devices-or-Equipment-V1-20260216.pdf
https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-PositionPaper-Demonstration-of-Safety-and-Performance-for-Combinatorial-Use-of-Devices-or-Equipment-V1-20260216.pdf
https://ec.europa.eu/commission/presscorner/detail/en/ip_26_505
https://ec.europa.eu/commission/presscorner/detail/en/ip_26_505
AESGP OTC News | March 2026 20 | 23
For further information, the links to the press release and the related Q&A are available here :
• Press release: https://ec.europa.eu/commission/presscorner/detail/en/ip_26_505
• Q&A: https://ec.europa.eu/commission/presscorner/detail/en/qanda_26_506
• Amending protocol to the agreement between the European Community and the Swiss Confederation
on mutual recognition in relation to conformity assessment, 24 February 2026
NEXT STEPS:
• On the EU side, ratification requires the consent of the European Parliament followed by formal
approval by the Council.
• In Switzerland, the package will be submitted to Parliament and is expected to be subject to a public
vote, with timing and details still to be confirmed.
https://ec.europa.eu/commission/presscorner/detail/en/ip_26_505
https://ec.europa.eu/commission/presscorner/detail/en/qanda_26_506
https://data.consilium.europa.eu/doc/document/ST-10572-2025-INIT/en/pdf
https://data.consilium.europa.eu/doc/document/ST-10572-2025-INIT/en/pdf
AESGP OTC News | March 2026 21 | 23
WFD+GWD+EQSD - Council position - 17 FEB 2026
The Council of the European Union formally adopted its position at the first reading on the revision
of the Water Framework Directive (2000/60/EC), Groundwater Directive (2006/118/EC), and
Environmental Quality Standards Directive (2008/105/EC) on 17 February 2026.
The press release and supportive documentation are available here: Safeguarding water quality: Council
signs off on stricter protection rules for surface water and groundwater - Consilium.
Below are an overview of the adopted changes and their implications:
Updated priority substance lists
• The revised directive updates the lists of priority substances in surface and groundwater. Key
substance groups include:
o PFAS: a group standard for 24 PFAS and the addition of TFA in surface waters
o Pharmaceuticals (e.g., pain-relief, anti-inflammatory, and antibiotic substances)
o Bisphenol A: identified as a priority hazardous substance.
• However, please note that this update does not pose drastic changes to the compromised text
on the revised directives published November 2025.
Monitoring and reporting
• The revised legislation introduces monitoring and reporting like:
o Effect-based monitoring : to assess the cumulative effect of chemical mixtures
o Enhanced reporting obligations : requiring Member States to provide more transparent
biological, chemical, and water body status information
o Use of remote sensing and earth-observation technologies
o Microplastics and antimicrobial resistance indicators in EU water watchlists to
support future reviews.
• Even if the self-care sector is not required to monitor emissions, we may need still track and
report substance use internally, respond requests from authorities, and support supply chain
transparency for substance newly regulated as priority pollutants.
Compliance timelines
• The Council has adopted position to maintain phased compliance:
o 2033 : for specific substances with newly tightened environmental quality standards
o 2039 : for full compliance with updated requirements across surface and groundwater.
Environment
https://www.consilium.europa.eu/en/press/press-releases/2026/02/17/safeguarding-water-quality-council-signs-off-on-stricter-protection-rules-for-surface-water-and-groundwater/
https://www.consilium.europa.eu/en/press/press-releases/2026/02/17/safeguarding-water-quality-council-signs-off-on-stricter-protection-rules-for-surface-water-and-groundwater/
AESGP OTC News | March 2026 22 | 23
European Observatory on Health Systems and Policies -
Environmental footprint of healthcare facilities - 24 FEB
2026
An update has been shared following the European Observatory on Health Systems and Policies
webinar on 24 February 2026, focusing on ‘How Can Healthcare Facilities Reduce Their Environmental
Footprint?’.
The link to the webinar recording is here: How can health care facilities reduce their environmental
footprint?.
Some key takeaways from the webinar are available below:
Growing sustainability actions in healthcare
The Observatory highlighted a clear shift from high-level environmental commitments towards practical,
measurable actions with healthcare facilities, including waste minimisation, reduced energy consumption,
water-saving strategies, and greener procurement approaches. These measures reflect broader EU
sustainability trends and connect to industry responsibility across the product lifecycle.
You can find the shared policy brief on the reduction of environmental footprint in healthcare
facilities here: How can health care facilities reduce their environmental footprint and contribute to more
sustainable health systems?.
Country case studies
The selected speakers from Denmark, Austria, and Spain (Catalonia region) presented how national and
regional authorities are combining environmental performance with healthcare governance.
These examples include mandatory monitoring tools and dashboards, sustainability criteria built into public
procurement, and investment plans aligned with climate objectives.
You can find a scientific paper on the healthcare and climate change here: The role of the health
sector in tackling climate change: A narrative review - ScienceDirect.
WHO perspective: aligning environmental objectives and patient care
The World Health Organisation (WHO) emphasised that reducing the environmental footprint must go
together with patient safety and workforce readiness.
This message reinforces that environmental measures are not external add-ons but rather increasingly
part of healthcare quality and system resilience.
Green skills as a strategic priority
The Observatory also presented its policy brief on building a climate-smart health and care workforce,
noting the need for new competencies, training pathways, and organisational cultures that integrate
sustainability.
This trend may influence future expectations in areas like environmental monitoring, safe handling of
chemicals, waste management procedures, and pharmaceuticals-related emissions.
A policy brief on the green skills is available here: Green skills for a sustainable future: Building a
climate-smart health and care workforce in the European Union.
https://eurohealthobservatory.who.int/news-room/events/item/2026/02/24/default-calendar/how-can-health-care-facilities-reduce-their-environmental-footprint
https://eurohealthobservatory.who.int/news-room/events/item/2026/02/24/default-calendar/how-can-health-care-facilities-reduce-their-environmental-footprint
https://eurohealthobservatory.who.int/publications/i/how-can-health-care-facilities-reduce-their-environmental-footprint-and-contribute-to-more-sustainable-health-systems
https://eurohealthobservatory.who.int/publications/i/how-can-health-care-facilities-reduce-their-environmental-footprint-and-contribute-to-more-sustainable-health-systems
https://www.sciencedirect.com/science/article/pii/S0168851024000630?via%3Dihub
https://www.sciencedirect.com/science/article/pii/S0168851024000630?via%3Dihub
https://eurohealthobservatory.who.int/publications/i/green-skills-for-a-sustainable-future-building-a-climate-smart-health-and-care-workforce-in-the-european-union
https://eurohealthobservatory.who.int/publications/i/green-skills-for-a-sustainable-future-building-a-climate-smart-health-and-care-workforce-in-the-european-union
AESGP — Association of the
European Self-Care Industry
Avenue de Tervuren, 7
1040 Brussels Belgium
info@aesgp.eu
www.aesgp.eu
07.04.2026
Datei
PD
Quality of herbal
medicinal products
Difficulties in the interpretation of fingerprint chromatograms –
Part 3*)
Authors: Thomas Goerke, MCM Klosterfrau Vertriebsgesellschaft | Dr. Christiane Halbsguth, Max Zeller Söhne |
Dr. Sebastian Gehlen-Breitbach, Bayer Consumer Health, Steigerwald Arzneimittelwerk | Rebecca Schönherr,
Merz Consumer Care | Dr. Hagen Albert, Salus Haus | Meike Onken, Pharmazeutische Fabrik Evers |
Dr. Rainer Kolkmann, Diapharm | Dr. Nico Symma, Pharma Deutschland
Correspondence: Dr. Nico Symma | Pharma Deutschland e. V., Ubierstr. 71–73, 53173 Bonn |
symma@pharmadeutschland.de
n Abstract
For quality control and stability testing of herbal substances and herbal preparations, chromatographic fingerprinting is a
widely used, important analytical method. The European Pharmacopoeia (Ph. Eur.) as well as guidelines of the European
Medicines Agency’s Committee on Herbal Medicinal Products (HMPC) request that chromatographic fingerprints must be
comparable to the specification. As “comparable” is not further defined and does not mean identical, the comparability of
chromatograms remains challenging and in practice conflicts arise due to individual interpretation. This publication is
intended to present examples of often occurring deviations in fingerprint chromatograms and discusses and assesses their
impact on the quality of the herbal medicinal products.
n Keywords
Fingerprint | HPLC | Structural Changes | Michael Addition | Isomerisation
2. Challenges of chromatographic
fingerprints
2.2 Liquid chromatography
2.2.5 Changes of chemical structure
The following 3 examples are used to describe variabilities in
high performance liquid chromatography (HPLC) fingerprint
chromatograms that are not due to methodological reasons
but can be attributed to structural changes (e.g. isomeriza-
tion, rearrangements or other chemical changes) of certain
plant constituents. It is often difficult to assess whether
these structures were already genuinely present in the plant
material or must be regarded as artefacts that arise during
the production/storage of the extracts/tinctures and/or
finished dosage forms.
Such differentiation is crucial for assessing whether
these changes represent quality-relevant deviations or can
be regarded as natural variations within the extracts and
tinctures.
2.2.5.1 Isomerisation of di-caffeoylquinic acids in Arni-
ca tincture Ph. Eur.
Figure 9 shows 2 mirrored HPLC-UV fingerprint chromato-
grams. The upper one is a chromatogram of a semi-solid
dosage form with Arnica tincture Ph. Eur. at time t0 and the
bottom one was recorded after 3 months storage under
accelerated conditions (40 °C/75 % relative humidity (RH)).
A reduction in the peak at Rt 6.5 min (substance 2) and a
simultaneous increase in the peak at Rt 2.9 min (sub-
stance 1) can be clearly seen. Although qualitatively compar-
able chromatograms are available, a quantitative peak shift
from substance 2 to substance 1 can be observed.
In order to explain this peak shift via a possible structural
connection, high-resolution mass spectrometry investiga-
tions using electrospray ionization (ESI) in positive mode
coupled with liquid chromatography (LC-ESI(+)-HRMS)
were carried out. Connecting the LC method with high-reso-
lution mass spectrometry allows the calculation of the sum
formula via the isotope cluster by the exact determination of
the mass-to-charge ratio (m/z) in addition to the molar peak
information.
It could be shown that the full scan spectra for both sam-
ples are identical and both substances form a quasi-molecu-
Analytik
*) Part 1 and 2 see Pharm. Ind. 2025;87(11):1049–11054 and
Pharm. Ind. 2026;88(1):54–59.
230 Goerke et al. | Herbal medicinal products – Part 3
Pharm. Ind. 88, Nr. 3, 230–237 (2026)
© ECV • Editio Cantor Verlag, Aulendorf
mailto:symma@pharmadeutschland.de
lar ion [M+H]+ at m/z 517.1340. The resulting molecular for-
mula is C25H25O12.
Figure 10 shows the fragmentation spectra of the
monoisotopic mass m/z 517.1340 of both substances. The
retention times in LC-HRMS differ from those in LC-UV
due to the adjustment of the eluent with regard to MS
compatibility.
The spectra show the same fragmentation behaviour
and prove that these must be isomeric structures of the
di-caffeoylquinic acid esters (C25H24O12) typical in Arnica.
The acyl migration of caffeic acid described in the liter-
ature [17] for this substance class could be the cause
of the isomerization here (Figure 11). This migration is
influenced by temperature, light and type of solvent.
Figure 9: Fingerprint chromatograms of an Arnica ointment t0 (top) and t3 at 40 °C/75 % RH (bottom, all figures
provided by the authors).
Figure 10: Fragmentation spectrum of the 2 peaks m/z 517.1340.
Pharm. Ind. 88, Nr. 3, 230–237 (2026)
© ECV • Editio Cantor Verlag, Aulendorf Goerke et al. | Herbal medicinal products – Part 3 231
This example demonstrates variabilities in the fin-
gerprint of stability tests that were not related to
methodological reasons. It was shown that isomerization
within the substance class of di-caffeoylquinic acids
takes place, which cannot be avoided. In principle, such
isomerization should not constitute a quality defect, as
the isomers can be regarded as natural components of
the plant.
2.2.5.2 Peak shift due to rearrangement of phenyl-
ethanoids in Ribwort plantain fluid extract
Figure 12 shows the fingerprint chromatogram of a liquid
dosage form with Ribwort plantain fluid extract at time
t0 (top) and after 6 months of storage under accelerated
conditions (40 °C/75 % RH, bottom).
Here, like the di-caffeoylquinic acids in Arnica tincture
(see chapter 3.2.4.1), the reduction of a peak at Rt 30.5 min
Analytik
Figure 11: Acyl migration mechanism of 3,5- dicaffeoylquinic acid (diCQA) to 3,4-diCQA or 4,5-diCQA, modified
according to [17].
Figure 12: Fingerprint chromatograms of a juice with Ribwort plantain fluid extract at time t0 (top) and t6 (bottom),
at 40 °C 75 % RH.
232 Goerke et al. | Herbal medicinal products – Part 3
Pharm. Ind. 88, Nr. 3, 230–237 (2026)
© ECV • Editio Cantor Verlag, Aulendorf
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Risikomanagement in
der Pharmaindustrie
and the simultaneous increase of a peak at Rt 34.0 min can
be clearly seen. Although qualitatively comparable chro-
matograms are available, a quantitative peak shift can also
be observed. LC-ESI(+)-HRMS investigations were also car-
ried out to prove a suspected correlation between these two
peaks. It could be shown that the full scan spectra are also
identical in this example.
Both peaks form a quasi-molecular ion [M+NH4]+ at m/
z 642.2388. The resulting molecular formula corresponds to
C29H40O15N. Figure 13 shows the fragmentation spectra of
the monoisotopic masses of the 2 peaks. The spectra show
the same fragmentation behaviour and prove that these
must be isomeric structures of the phenylethanoids verbas-
coside and isoverbascoside (C29H36O15) typical of Ribwort
plantain (fig. 14). This assumption was verified using certified
reference materials. It was found that the second peak Rt
34.0 min is isoverbascoside, which is presumably also formed
from the verbascoside by the described acyl migration.
2.2.5.3 Michael addition of ethanol on sesquiterpene
lactones in Arnica tincture Ph. Eur.
This example deals with changes in the fingerprint chro-
matograms for sesquiterpene lactones in Arnica tincture
Ph. Eur. Sesquiterpene lactones are typical ingredients of Ar-
Analytik
Figure 13: Fragmentation spectra of the 2 peaks m/z 642.2386.
234 Goerke et al. | Herbal medicinal products – Part 3
Pharm. Ind. 88, Nr. 3, 230–237 (2026)
© ECV • Editio Cantor Verlag, Aulendorf
nica and are specified in the monograph of Arnica tincture
with a minimum content of 0.04 %. The sesquiterpene lac-
tones of Arnica are mainly esters of the helenalin and 11,13-
dihydrohelenalin type. They differ in the type of acid residue
of the ester group, whereby various
short-chain fatty acids occur. This re-
sults in up to 6 different structures for
each type.
In the HPLC method described in
the Ph. Eur. Monograph Arnicae tinc-
ture [19], 2 integration markers are set,
within which all peaks are evaluated
as sesquiterpene lactones in total.
The following HPLC overlay (fig. 16)
shows the HPLC-UV fingerprint chro-
matograms of an Arnica tincture
Ph. Eur. According to the method of
the monograph at different test times.
The black chromatogram represents
the chromatogram at time t0, the blue
chromatogram shows the analysis after
6 months of storage under accelerated
conditions (40° C/75 % RH). Once
again, quantitative shifts can be seen
in chromatograms that are basically
comparable in qualitative terms. In
particular, the peak areas of the hele-
nalin-type sesquiterpene lactones are
significantly reduced, with a simulta-
neous increase in the peak areas of
structures outside the selected back in-
tegration marker (large peak at Rt
11.4 min).
LC-HRMS investigations were also carried out to prove a
direct correlation here. It could be shown that the mass
spectra of the structures in the rear chromatogram show
strong similarities with the spectra of the sesquiterpene lac-
Figure 14: Chemical structures of verbascoside and isoverbascoside.
Figure 15: Sesquiterpene lactones in Arnica; modified after [18].
Figure 16: Fingerprint chromatogram HPLC-UV of an Arnica tincture EP at time t0 and after t6 at 40 °C/75 % RH.
Pharm. Ind. 88, Nr. 3, 230–237 (2026)
© ECV • Editio Cantor Verlag, Aulendorf Goerke et al. | Herbal medicinal products – Part 3 235
tones and that the shifts in the fingerprint chromatogram
are probably due to an addition of ethanol to the α,β-un-
saturated carbonyl structure, in the sense of a Michael
addition [20].
Here, the sesquiterpene lactones of the helenalin type
are primarily affected, which is certainly also due to the
fact that helenanolides carry 2 such functionalities and the
addition at position 13 is favoured. Figure 18 shows the mass
traces of the typical fragments after cleavage of the fatty
acid residues for the helenanolides (m/z 245) and its mono-
(m/z 291) and di-ethoxy derivatives (m/z 337). The inte-
gration marker is shown as an additional mass trace for ori-
entation in the chromatogram. The ethoxy derivatives of the
dihydrohelenanolides could not be detected in this pattern.
The known species in the mass traces could be assigned by
mass spectrometry using the molar peak information.
In this example, the addition of ethanol is certainly a
quality-relevant change, as these are artefacts that do
not occur in the plant. In the case of sesquiterpene lac-
tones, it must be assumed that the α,β-unsaturated car-
bonyl structure represents the reactive and active center
of the molecule, which is lost through the addition reac-
tion [21]. As explained, the described addition reaction
cannot be avoided and is determined by the ingredients
of the Arnica tincture. Arnica tincture is monographed
in the Ph. Eur., so it can be assumed that these changes
are acceptable as they are conform to the monograph.
Since the changes are due to the active ingredient, it is
hardly possible to obtain a stable finished product re-
garding the content of sesquiterpene lactones and their
fingerprint chromatograms when using Arnica tincture
Ph. Eur.
Analytik
Figure 17: Michael addition of ethanol to the α,β-unsaturated carbonyl structure; modified after [20].
Figure 18: Mass trace of the fragment M-OR of helenaline, 2-ethoxy-2,3-dihydrohelenaline or 13-ethoxy-11,13 dihy-
drohelenaline and 2,13-diethoxy-2,3,11,13-tetrahydrohelenaline as well as the integration marker.
236 Goerke et al. | Herbal medicinal products – Part 3
Pharm. Ind. 88, Nr. 3, 230–237 (2026)
© ECV • Editio Cantor Verlag, Aulendorf
2.2.6 Conclusion
In general, changes in fingerprint chromatograms observed
during shelf-life need to be assessed whether they are quality
relevant or not. The shown examples of a complex herbal
matrix analysed throughout shelf life and compared to a
frozen sample as well as 1 sample being analysed at different
laboratories or using different column batches are consid-
ered to show non-quality relevant deviations in the different
fingerprint chromatograms. When detecting peak shifts or
changes within the fingerprint chromatogram which cannot
be easily classified as non-quality relevant, further investiga-
tion of these changes can be useful. As shown for Arnica
and Ribwort plantain fluid extract, these changes may still
not be quality-relevant when arising due to isomerisation.
Quality relevant changes can be caused by Michael addition,
as shown for Arnica. Nevertheless, reactions that occur with-
in the active pharmaceutical ingredient and cannot be pre-
vented are considered to be taken into consideration in the
Ph. Eur. and therefore are expected to be acceptable.
Part 4 deals with gas chromatography and is expected to
be published in issue 5/2026.
n References
[17] Xue, M., et al., Stability and Degradation of Caffeoylquinic Acids
under Different Storage Conditions Studied by High-Performance
Liquid Chromatography with Photo Diode Array Detection and High-
Performance Liquid Chromatography with Electrospray Ionization
Collision-Induced Dissociation Tandem Mass Spectrometry.
Molecules, 2016. 21(7)
[18] Perry NB, Burgess EJ, Rodríguez Guitián MA, Romero Franco R, López
Mosquera E, Smallfield BM, Joyce NI, Littlejohn RP. Sesquiterpene
lactones in Arnica montana: helenalin and dihydrohelenalin chemo-
types in Spain. Planta Med. 2009 May;75(6):660-6. doi:10.1055/s-0029-
1185362.
[19] Arnicae tincture. European Pharmacopoeia. 11th edition. 2025. Stras-
bourg, France. Council of Europe
[20] Schmidt TJ, Matthiesen U, Willuhn G. On the stability of sesquiter-
pene lactones in the officinal Arnica tincture of the German Pharma-
copoeia. Planta Med. 2000;66(1):75–77.
[21] Schmidt TJ. Toxic activities of sesquiterpene lactones: structural and
biochemical aspects. Curr Org Chem. 1999;3(6):577–605.
Qualitätsmanagement
und Validierung
in der pharmazeutischen Praxis
Einführung | Anwendungsbeispiele | Musterdokumente
Im Mittelpunkt der pharmazeutischen Tätigkeit steht die Arzneimittelsicherheit.
Durch eine immer gleichbleibende hohe Qualität soll sichergestellt werden,
dass Arzneimittel für die Patientinnen und Patienten gefahrlos anwendbar
sind, keine unzumutbaren Nebenwirkungen aufweisen sowie sicher und frei
von Verunreinigungen sind. Erreicht wird die gefahrlose Anwendbarkeit eines
Arzneimittels durch ein umfassendes Qualitätsmanagementsystem, die
Qualifizierung von Gerätschaften und die Validierung der Herstellprozesse.
Die Verfasser, die allesamt aus der Praxis kommen, behandeln in den ersten
beiden Kapiteln die Grundlagen und Anforderungen an das pharmazeutische
Qualitätsmanagementsystem und diskutieren deren Anwendung. Dabei
werden auch die Regularien in anderen Ländern berücksichtigt. Im dritten
Kapitel werden die wichtigsten Elemente eines Qualitätsmanagementsystems
und Vorschläge für deren Implementierung vorgestellt. Das vierte Kapitel
wiederum ist der validen Umsetzung der regulatorischen Vorgaben anhand
zahlreicher Praxisbeispiele aus Qualifizierung und Validierung gewidmet.
Das fünfte Kapitel rundet das Buch durch eine kurze Einbeziehung
der Medizinprodukte, die sehr häufig in Kombination mit
Arzneimitteln verwendet werden, ab.
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ISBN: 978-3-87193-365-3
• 3., völlig neubearbeitete und erweiterte Auflage 2026
• Umfang: ca. 336 Seiten, 15,3 x 23 cm, Softcover
• Autoren: Bakhschai B., Bock M., Jahnke M.,
Peter Ch., Prinz H., Prinz Ch., Schwarz R.
• Preis: 78,00 €
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ecv basics
07.04.2026
Datei
Quality of herbal
medicinal products
Difficulties in the interpretation of fingerprint chromatograms –
Part 2*)
Authors: Thomas Goerke, MCM Klosterfrau Vertriebsgesellschaft | Dr. Christiane Halbsguth, Max Zeller Söhne |
Dr. Sebastian Gehlen-Breitbach, Bayer Consumer Health, Steigerwald Arzneimittelwerk | Rebecca Schönherr,
Merz Consumer Care | Dr. Hagen Albert, Salus Haus | Meike Onken, Pharmazeutische Fabrik Evers |
Dr. Rainer Kolkmann, Diapharm | Dr. Nico Symma, Pharma Deutschland
Correspondence: Dr. Nico Symma | Pharma Deutschland e. V., Ubierstr. 71–73, 53173 Bonn |
symma@pharmadeutschland.de
n Abstract
For quality control and stability testing of herbal substances and herbal preparations, chromatographic fingerprinting is a
widely used, important analytical method. The European Pharmacopoeia (Ph. Eur.) as well as guidelines of the European
Medicines Agency’s Committee on Herbal Medicinal Products (HMPC) request that chromatographic fingerprints must be
comparable to the specification. As “comparable” is not further defined and does not mean identical, the comparability of
chromatograms remains challenging and in practice conflicts arise due to individual interpretation. This publication is
intended to present examples of often occurring deviations in fingerprint chromatograms and discusses and assesses their
impact on the quality of the herbal medicinal products.
n Keywords
Fingerprint Chromatograms | HPLC | Column Batches | Laboratories | Peak Separation
2. Challenges of chromatographic
fingerprints
2.2 Liquid chromatography
2.2.1 Introduction
Due to its high precision and specificity, high-performance
liquid chromatography (HPLC) is very common in the analy-
sis of herbal active ingredients and has increasingly replaced
the earlier photometric methods.
High-performance liquid chromatography is a widely
used analytical technique, particularly for determining the
content of active plant substances in the finished product.
In addition to analysing the analytical marker for batch-spe-
cific recovery, HPLC fingerprints are also used to assess
quality. The high selectivity of HPLC especially when using
modern column materials, and high sensitivity of the differ-
ent detectors, mean that minor changes are becoming in-
creasingly visible. As more and more changes become visible,
the current requirement of fingerprints being “comparable”
throughout the complete shelf life, needs to be reassessed.
Furthermore, the detected changes need to be evaluated
whether they are relevant to quality.
2.2.2 Assessment of changes in non-marker peaks
During the annual stability testing of an herbal medicinal
product containing 4 dry extracts a validated test method
is applied for the qualitative and quantitative determina-
tion of Valerian dry extract and the qualitative determina-
tion of Hop dry extract. The same analytical system (appa-
ratus, procedure) is used for all measurements. While the
retention times of the analytical marker substances are
comparable, the peak patterns between the analytical mar-
kers change. Although chromatograms are not identical,
comparability of analytical data is given and the deduction
leading to this conclusion for the “maintenance of quality”
is discussed.
The method is an adaptation of the Ph. Eur. Monograph
Valerianae extractum hydroalcoholicum siccum [11] to the
finished herbal medicinal product containing 4 dry extracts.
The shown chromatograms depict the results of an annual
stability testing. The retention times of the analytical marker
Analytik
*) Part 1 see Pharm. Ind. 2025;87(11):1049–1054.
54 Goerke et al. | Herbal medicinal products – Part 2
Pharm. Ind. 88, Nr. 1, 54–59 (2026)
© ECV • Editio Cantor Verlag, Aulendorf
mailto:symma@pharmadeutschland.de
Figure 5: Chromatograms of annual stability (a) start [column batch 5291-0169], stored for 12 months at 25 °C/60 %
RH (b1) and deep frozen (b2) and (c) stored for 24 months at 25 °C/60 % RH [b and c: column batch 5291-0232]
(all figures provided by the authors).
Pharm. Ind. 88, Nr. 1, 54–59 (2026)
© ECV • Editio Cantor Verlag, Aulendorf Goerke et al. | Herbal medicinal products – Part 2 55
substances (acetoxyvalerenic acid, xanthohumol and valere-
nic acid) are comparable. However, the peak patterns eluting
between the above-mentioned analytical markers are differ-
ent if compared between start, 12 and 24 months (fig. 5). The
peak pattern is comparable after 12 months comparing the
chromatograms of samples stored at 25 °C, 60 % relative hu-
midity (RH) and deep frozen (here: -20 °C) samples (fig. 5, b1
and b2).
The comparison of HPLC chromatograms between start,
12 months and 24 months storage clearly shows that the re-
tention times of the 3 analytical markers deviate within a
small time frame. However, the peaks eluting between the
analytical markers show different separation and retention
times. On a 2nd glance, when comparing the chromatograms
after 12 months stored at 25 °C and 60 % RH with the chro-
matogram of the deep-frozen sample the peak pattern of the
chromatograms is identical/highly comparable.
As 4 different active pharmaceutical ingredients are com-
bined within this medicinal product, the complexity of the
matrix forms the major challenge of liquid chromatography
(LC) analysis. In complex herbal matrices, non-quality rele-
vant changes within the products cannot be excluded. As
the comparison of the 25 °C-samples with the deep-frozen
samples does not show any deviation in the peak pattern,
methodological impacts are highly likely. By comparison
with the deep-frozen sample, maintenance of quality is
demonstrated. Besides non-quality relevant changes within
the product, changes in the technical set up (apparatus, tub-
ings, etc.) can cause the observed variations.
2.2.3 Influence of different column batches
In Ph. Eur. 10.3 for Passiflorae herba [12] as well as for Passi-
florae herbae extractum siccum [13] an unspecific photo-
metric assay was replaced by an LC method. Before imple-
mentation into Ph. Eur., the LC method was tested in a ring
trial on retention times, selectivity, and precision of C-glyco-
syl flavones. Years later, other column batches of the same
column provider led to changes in pressure of the LC system
and to changes in the separation of C-glycosyl flavones of
Passionflower herb and Passionflower herb dry extract and
mixture of reference substances. All columns passed the
column test applied by the column manufacturer.
Analytik
Figure 6: Chromatogram of the reference substance solution applied to column 0191, 0175, 0221, 0228
(from top to bottom).
56 Goerke et al. | Herbal medicinal products – Part 2
Pharm. Ind. 88, Nr. 1, 54–59 (2026)
© ECV • Editio Cantor Verlag, Aulendorf
For all analyses Passionflower herb dry extract (batch
142395) was used and applied to the same LC/UV system.
In a 1st experiment, a reference substance solution con-
taining the 5 flavonoids orientin, isoorientin, vitexin, isovi-
texin and swertisin was analysed using 4 different column
batches (batches 0191, 0175, 0221, 0228) on the same LC
system. The direct comparison of chromatograms shows
the variability of retention times due to different column
batches (fig. 6).
Secondly, Passionflower herb dry extract (batch 142395)
was analysed using the same 4 column batches (batches 0191,
0175, 0221, 0228) on the identical LC system. The pressure at
start of the gradient differed between 643 bar (0228) and
831 bar (0175). Variability in retentions times can be seen in
analogy to the chromatograms of the reference substance
solution (fig. 7). However, due to the more complex matrix of
Passionflower herb dry extract, an influence on peak separa-
tion is observed in addition.
According to the column manufacturer, certain varia-
tions between different column batches are common. The
chromatograms show differences in peak resolution and/
or retention times between orientin and isovitexin as well
as between isoorientin and vitexin. In daily business it is
not feasible to always measure on the same LC apparatus
with the same column batch. Even though it is recom-
mendable to put several columns of the same batch on
stock for stability testing, the challenge to change a col-
umn batch in daily business remains for release testing.
As long as peak separation is given, chromatograms in
this example are regarded as comparable. If peak separa-
tion changes or the pressure of the LC system increases
significantly, an impact on the overall content of flavo-
noids must be carefully ruled out.
Due to complex matrix effects of herbal extracts/
medicinal products, peak separation in chromatograms is
challenging and analytically high-end. One suggestion to im-
prove the consistency of batch-to-batch variability of col-
umns could be to use complex herbal matrices as test mate-
rial for peak separation in column tests.
2.2.4 Different laboratories, same method,
different results
As already shown, fingerprint chromatograms are very sensi-
tive to changes in the sample. Nevertheless, changes during
shelf life seem to be very common in herbal extracts [14,15].
Besides changes within the extract, external factors can also
influence the fingerprint chromatogram.
It is common practice for manufacturers to work with
several different laboratories to ensure steady production
and release analysis in case of bottlenecks at 1 laboratory.
To ensure correct operation of the different methods, an
identical method is implemented and transferred, where dif-
Figure 7: Chromatogram of the Passionflower herb dry extract applied to column 0191, 0175, 0221, 0228
(from top to bottom).
Pharm. Ind. 88, Nr. 1, 54–59 (2026)
© ECV • Editio Cantor Verlag, Aulendorf Goerke et al. | Herbal medicinal products – Part 2 57
ferent parameters like limit of quantification or linearity are
checked to be equivalent [16].
One sample of a herbal extract was sent to 3 different
laboratories, which all implemented and tested the same
ultra-high-performance liquid chromatography (UHPLC) UV
method. The method transfer was classified as successful
with all checked validation parameters being within the ac-
cepted limits. Each laboratory processed the sample indivi-
dually and analysed it using double determination. Both
obtained chromatograms were identical, wherefore each
laboratory accepted the results as correct. Figure 8 shows
the chromatograms obtained at each laboratory.
The pharmacologically active substance is unknown for
this extract, wherefore an analytical marker is used for analy-
sis. Since the results for this marker differed between the lab-
oratories, the chromatograms were inspected in more detail.
The chromatograms not only show differences for the
analytical marker but also differences in signal intensity, re-
Analytik
Figure 8: Photodiode array (PDA) chromatogram of the herbal extract obtained at laboratory 1 (top), 2 (middle) and
3 (bottom).
58 Goerke et al. | Herbal medicinal products – Part 2
Pharm. Ind. 88, Nr. 1, 54–59 (2026)
© ECV • Editio Cantor Verlag, Aulendorf
tention time, and existence of other peaks. The differences
may be partially explained by the different processing of the
sample, but nevertheless, these results show that the chro-
matographic fingerprint is a very sensitive parameter, where
the definition of “comparable”, as required by the Ph. Eur.,
needs to be reconsidered.
For this special case, the obtained chromatograms re-
sulted in a restriction of the used laboratories for this
analysis. Additionally, a double determination using 2 dif-
ferent instruments was implemented to receive results
as true as possible. In general, these results show that a
laboratory change should not be carried out during active
stability studies as comparability of the results can be
limited.
Part 3 contains further information on LC and is ex-
pected to be published in issue 3/2026. Part 4 deals with
gas chromatography and is expected to be published in issue
5/2026.
n References
[11] Valerianae extractum hydroalcoholicum siccum. European Pharma-
copoeia. 11th edition. 2025. Strasbourg, France. Council of Europe
[12] Passiflora herba. European Pharmacopoeia. 10th edition. 2025.
Strasbourg, France. Council of Europe
[13] Passiflorae herbae extractum siccum. European Pharmacopoeia.
10th edition. 2025. Strasbourg, France. Council of Europe
[14] Narayana DB, Dobriyal RM. Shelf-life of herbal remedies: challenges
and approaches. In: Kunle OF, editor. Evaluation of Herbal Medicinal
Products. Amsterdam: Elsevier; 2009. p. 369–79.
[15] Bansal S, Choudhary M, Sharma S, Khare P, Sehgal PK. Stability
testing of herbal drugs: challenges, regulatory compliance and
perspectives. Phytother Res. 2016;30(5):701–11.
[16] Scypinski S, Morris C, Lau J. Pharmaceutical Research and Manu-
facturers Association acceptable analytical practice for analytical
method transfer. Pharm Technol. 2002;26(6):84–8.
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Die Begutachtungsanleitung Richtlinie des Medizinischen Dienstes Bund nach § 283 Absatz 2 Satz 1 Nr. 2 SGB V Festbetragsarzneimittel (BGA Festbeträge) soll sicherstellen, dass auch im Festbetragssystem eine bedarfsgerechte Versorgung mit Arzneimitteln erfolgt. Der MD Bund hat nun die die finale Fassung auf seinen Webseiten veröffentlicht. Diese Richtlinie wurde vom Medizinischen Dienst Bund unter fachlicher Beteiligung der Medizinischen Dienste und des Sozialmedizinischen Dienstes Deutsche Rentenversicherung Knappschaft-Bahn-See erstellt und nach ordnungsgemäßer Durchführung des Beteiligungs- und Anhörungsverfahrens und ist am 03.04.2026 in Kraft getreten. Die BGA Festbeträge soll Gutachterinnen und Gutachtern klare Leitplanken für eine fachlich fundierte und einheitliche Bewertung geben. Neben den sozialrechtlichen Grundlagen zum Festbetragssystem enthält sie auch sozialmedizinische Aspekte zum Begutachtungsanlass und erläutert die Kriterien und Maßstäben der Begutachtung anhand von Ablaufdiagrammen und beleuchtet für die Entscheidungsfindung relevante Urteile des Bundessozialgerichtes.
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Die Digitalisierung des Gesundheitswesens steht an der Schwelle zu einer europäischen Vernetzung von Gesundheitsdaten. In dieser Session erfahren Sie, wie die EUDI-Wallet die Anmeldung beim Leistungserbringer revolutioniert und wie nationale ePA-Systeme durch europäische Standards und Interoperabilität zukunftsfähig gestaltet werden können. Anhand von Praxisbeispielen – darunter das Pilotprojekt der AOK connect GbR – werden beleuchtet: - Technische, semantische und organisatorische Anforderungen für eine europakompatible ePA - Innovative Lösungsansätze für sichere, nutzerfreundliche Anmelde- und Datenfreigabeprozesse - Lessons Learned aus der Integration in bestehende Systeme und der Telematikinfrastruktur - Chancen und Herausforderungen der EHDS-Verordnung für Patienten, Leistungserbringer und Industrie Die Session richtet sich an Entscheidungsträger, IT-Experten und Healthcare-Enabler, die einen praxisnahen Einblick in die grenzüberschreitende Gesundheitsdigitalisierung erhalten und verstehen wollen, wie digitale Identitäten und interoperable Plattformen die Versorgung der Zukunft gestalten können. --- Präsentationen: 1. ePA 4 EHDS | Lena Dimde & Charly Bunar, gematik GmbH 2. Primary Data Use in the EHDS: Lessons Learned from the French Electronic Health Record I Emilie Passemard, Ministère de la Santé 3. NCPeH: Wie die elektronische Patientenakte europafähig wird – Interoperabilität und Strategie im Kontext des European Health Data Space | Kornell Adolph, AOK connect | Inger Koltermann, AOK connect 4. Europe’s Next Health Data Chapter: Proven Insights from 20 Years of Dutch Health Information Exchange | Alexander Zautke, Firely | Andries Hamster, Health B.V. 5. Die EUDI Wallet als Innovator für die Anmeldung von Patientinnen und Patienten bei Leistungserbringern | Julian Hartz, Verband der Privaten Krankenversicherung | Janina Buchholz, PKV Zur Veranstaltungsübersicht auf der DMEA Webseite . Dies ist eine Veranstaltung vom Bundesverband Gesundheits-IT – bvitg e. V. und der Messe Berlin.
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