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7 April 2026
EMA/PRAC/68437/2026
Human Medicines Division
Pharmacovigilance Risk Assessment Committee (PRAC)
Draft agenda for the meeting on 07-10 April 2026
Chair: Ulla Wändel Liminga – Vice-Chair: Liana Martirosyan
07 April 2026, 09:30 – 19:30, via teleconference
08 April 2026, 08:30 – 19:30, via teleconference
09 April 2026, 08:30 – 19:30, via teleconference
10 April 2026, 08:30 – 16:00, via teleconference
Disclaimers
Some of the information contained in this agenda is considered commercially confidential or sensitive
and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed
against products, it must be noted that these may not reflect the full wording proposed by applicants
and may also change during the course of the review. Additional details on some of these procedures
will be published in the PRAC meeting highlights once the procedures are finalised.
Of note, this agenda is a working document primarily designed for PRAC members and the work the
Committee undertakes.
Note on access to documents
Some documents mentioned in the agenda cannot be released at present following a request for
access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on-
going procedures for which a final decision has not yet been adopted. They will become public when
adopted or considered public according to the principles stated in the Agency policy on access to
documents (EMA/127362/2006 Rev.1).
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Pharmacovigilance Risk Assessment Committee (PRAC)
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Table of contents
1. Introduction 9
1.1. Welcome and declarations of interest of members, alternates and experts ............ 9
1.2. Agenda of the meeting on 07-10 April 2026 ........................................................... 9
1.3. Minutes of the previous meeting on 09-12 March 2026 .......................................... 9
2. EU referral procedures for safety reasons: urgent EU procedures 9
2.1. Newly triggered procedures ................................................................................... 9
2.2. Ongoing procedures ............................................................................................... 9
2.3. Procedures for finalisation...................................................................................... 9
3. EU referral procedures for safety reasons: other EU referral
procedures 9
3.1. Newly triggered procedure ..................................................................................... 9
3.2. Ongoing procedures ............................................................................................... 9
3.3. Procedures for finalisation.................................................................................... 10
3.4. Re-examination procedures .................................................................................. 10
3.5. Others .................................................................................................................. 10
4. Signals assessment and prioritisation 10
4.1. New signals detected from EU spontaneous reporting systems and/or other sources
............................................................................................................................. 10
4.1.1. Binimetinib - MEKTOVI (CAP); Encorafenib – BRAFTOVI (CAP) ...................................... 10
4.2. Signals follow-up and prioritisation ...................................................................... 10
4.2.1. Axicabtagene ciloleucel – YESCARTA (CAP) - EMEA/H/C/002695/SDA/019; lisocabtagene
maraleucel – BREYANZI (CAP) - EMEA/H/C/002695/SDA/025 ....................................... 10
4.2.2. Ponatinib - ICLUSIG (CAP) - EMEA/H/C/002695/SDA/019 ............................................. 11
4.2.3. Tirzepatide - MOUNJARO (CAP); MOUNJARO KWIKPEN (CAP) - EMEA/H/C/005620/SDA/00711
4.3. Variation procedure(s) resulting from signal evaluation ...................................... 11
5. Risk management plans (RMPs) 11
5.1. Medicines in the pre-authorisation phase ............................................................. 11
5.1.1. Catequentinib - (CAP MAA) - EMEA/H/C/006317, Orphan ............................................. 11
5.1.2. Denosumab - (CAP MAA) - EMEA/H/C/006626 ............................................................ 11
5.1.3. Ensitrelvir - (CAP MAA) - EMEA/H/C/006063 .............................................................. 12
5.1.4. Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated - (CAP
MAA) - EMEA/H/C/006692 ........................................................................................ 12
5.1.5. Insulin efsitora alfa - (CAP MAA) - EMEA/H/C/006388 ................................................. 12
5.1.6. Leriglitazone - (CAP MAA) - EMEA/H/C/006693, Orphan .............................................. 12
5.1.7. Levodopa / Carbidopa - (CAP MAA) - EMEA/H/C/006629 .............................................. 12
5.1.8. Narsoplimab - (CAP MAA) - EMEA/H/C/005247, Orphan .............................................. 12
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5.1.9. Norucholic acid - (CAP MAA) - EMEA/H/C/006515, Orphan ........................................... 12
5.2. Medicines in the post-authorisation phase – PRAC-led procedures ....................... 12
5.2.1. Bosentan – STAYVEER (CAP); TRACLEER (CAP) – EMA/VR/0000316336 ......................... 12
5.2.2. Carfilzomib – KYPROLIS (CAP) – EMA/VR/0000325402 ................................................. 13
5.2.3. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000291534................................................ 13
5.3. Medicines in the post-authorisation phase – CHMP-led procedures ...................... 13
5.3.1. Afamelanotide – SCENESSE (CAP) – EMA/VR/0000325360 ........................................... 13
5.3.2. Alpelisib – PIQRAY (CAP) – EMA/VR/0000317159 ........................................................ 13
5.3.3. Atogepant – AQUIPTA (CAP) – EMA/VR/0000310717 .................................................... 14
5.3.4. Axicabtagene ciloleucel – YESCARTA (CAP); Brexucabtagene autoleucel – TECARTUS (CAP) –
EMA/VR/0000308229 ............................................................................................... 14
5.3.5. Berotralstat – ORLADEYO (CAP) – EMA/X/0000268892 ................................................. 15
5.3.6. Capivasertib – TRUQAP (CAP) – EMA/VR/0000293735 .................................................. 15
5.3.7. Ceftolozane / Tazobactam – ZERBAXA (CAP) – EMA/VR/0000320716 ............................. 15
5.3.8. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000320534 .......................... 16
5.3.9. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (CAP) – EMA/X/0000314697.................. 16
5.3.10. Decitabine / Cedazuridine – INAQOVI (CAP) – EMA/VR/0000304730 .............................. 17
5.3.11. Deucravacitinib – SOTYKTU (CAP) – EMA/VR/0000309456 ............................................ 17
5.3.12. Evolocumab – REPATHA (CAP) – EMA/VR/0000322435 ................................................. 17
5.3.13. Fedratinib – INREBIC (CAP) – EMA/VR/0000324950 ..................................................... 18
5.3.14. Human normal immunoglobulin – PRIVIGEN (CAP) – EMA/VR/0000304719 ..................... 18
5.3.15. Influenza vaccine (live, nasal) – FLUENZ (CAP) – EMA/VR/0000302352 .......................... 18
5.3.16. Insulin icodec / Semaglutide – KYINSU (CAP) – EMA/VR/0000322527 ............................ 18
5.3.17. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) –
EMA/VR/0000327431 ............................................................................................... 19
5.3.18. Mavacamten – CAMZYOS (CAP) – EMA/VR/0000294573 ............................................... 19
5.3.19. Naloxone – NYXOID (CAP) – EMA/VR/0000325329 ...................................................... 20
5.3.20. Nivolumab – OPDIVO (CAP) – EMA/VR/0000304938 .................................................... 20
5.3.21. Pandemic influenza vaccine (H5N1) (live attenuated, nasal) – PANDEMIC INFLUENZA VACCINE
H5N1 ASTRAZENECA (CAP) – EMA/VR/0000321324 ..................................................... 20
5.3.22. Risankizumab – SKYRIZI (CAP) – EMA/X/0000296763 ................................................. 20
5.3.23. Sacituzumab govitecan – TRODELVY (CAP) – EMA/VR/0000320818 ............................... 21
5.3.24. Semaglutide – WEGOVY (CAP) – EMA/X/0000296344................................................... 21
5.3.25. Semaglutide – WEGOVY (CAP) – EMA/VR/0000327359 ................................................. 21
5.3.26. Teclistamab – TECVAYLI (CAP) – EMA/VR/0000322279 ................................................ 22
5.3.27. Tedizolid phosphate – SIVEXTRO (CAP) – EMA/X/0000282136 ...................................... 22
5.3.28. Tezepelumab – TEZSPIRE (CAP) – EMA/VR/0000321455 .............................................. 22
5.3.29. Tolvaptan – JINARC (CAP) – EMA/VR/0000246866 ...................................................... 23
5.3.30. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000322236 .............................. 23
5.3.31. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000293327 .............................. 23
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5.3.32. Vamorolone – AGAMREE (CAP) – EMA/VR/0000293535 ................................................ 24
5.3.33. Venetoclax – VENCLYXTO (CAP) – EMA/VR/0000322237 .............................................. 24
5.3.34. Venetoclax – VENCLYXTO (CAP) – EMA/VR/0000322240 .............................................. 24
6. Periodic safety update reports (PSURs) 25
6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products
(CAPs) only .......................................................................................................... 25
6.1.1. Abrocitinib – CIBINQO (CAP) – EMA/PSUR/0000317674 ............................................... 25
6.1.2. Aprocitentan – JERAYGO (CAP) – EMA/PSUR/0000317689 ............................................ 25
6.1.3. Asenapine – SYCREST (CAP) – EMA/PSUR/0000317636 ................................................ 25
6.1.4. Bedaquiline – SIRTURO (CAP) – EMA/PSUR/0000317651 .............................................. 26
6.1.5. Brentuximab vedotin – ADCETRIS (CAP) – EMA/PSUR/0000317688 ............................... 26
6.1.6. Caplacizumab – CABLIVI (CAP) – EMA/PSUR/0000317662 ............................................ 26
6.1.7. Cenobamate – ONTOZRY (CAP) – EMA/PSUR/0000317671 ........................................... 26
6.1.8. Crizotinib – XALKORI (CAP) – EMA/PSUR/0000317663 ................................................. 26
6.1.9. Damoctocog alfa pegol – JIVI (CAP) – EMA/PSUR/0000317669 ..................................... 26
6.1.10. Dasiglucagon – ZEGALOGUE (SRD) – EMA/PSUR/0000317683 ...................................... 27
6.1.11. Deucravacitinib – SOTYKTU (CAP) – EMA/PSUR/0000317694 ........................................ 27
6.1.12. Doravirine – PIFELTRO (CAP) – EMA/PSUR/0000317664 ............................................... 27
6.1.13. Doravirine / Lamivudine / Tenofovir disoproxil – DELSTRIGO (CAP) – EMA/PSUR/0000317666
............................................................................................................................. 27
6.1.14. Duvelisib – COPIKTRA (SRD) – EMA/PSUR/0000317672 ............................................... 27
6.1.15. Ebola vaccine (Ad26.ZEBOV-GP [recombinant]) – ZABDENO (CAP); Ebola vaccine (MVA-BN-
Filo [recombinant]) – MVABEA (CAP) – EMA/PSUR/0000317690 .................................... 28
6.1.16. Epcoritamab – TEPKINLY (CAP) – EMA/PSUR/0000317637 ............................................ 28
6.1.17. Filgotinib – JYSELECA (CAP) – EMA/PSUR/0000317681 ................................................ 28
6.1.18. Fruquintinib – FRUZAQLA (CAP) – EMA/PSUR/0000317678 ........................................... 28
6.1.19. Ganaxolone – ZTALMY (CAP) – EMA/PSUR/0000317639 ............................................... 28
6.1.20. Infliximab – FLIXABI (CAP); INFLECTRA (CAP); REMICADE (CAP); REMSIMA (CAP); ZESSLY
(CAP) – EMA/PSUR/0000317670 ............................................................................... 29
6.1.21. Insulin icodec – AWIQLI (CAP) – EMA/PSUR/0000317726 ............................................. 29
6.1.22. Lebrikizumab – EBGLYSS (CAP) – EMA/PSUR/0000317693 ........................................... 29
6.1.23. Linaclotide – CONSTELLA (CAP) – EMA/PSUR/0000317653 ........................................... 29
6.1.24. Lorlatinib – LORVIQUA (CAP) – EMA/PSUR/0000317668 ............................................... 29
6.1.25. Influenza vaccine (live, nasal) – FLUENZ (CAP) – EMA/PSUR/0000317656 ...................... 29
6.1.26. Mecasermin – INCRELEX (CAP) – EMA/PSUR/0000317644 ............................................ 30
6.1.27. Mepolizumab – NUCALA (CAP) – EMA/PSUR/0000317655 ............................................. 30
6.1.28. Momelotinib – OMJJARA (CAP) – EMA/PSUR/0000317675 ............................................. 30
6.1.29. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) –
EMA/PSUR/0000317654 ........................................................................................... 30
6.1.30. Ofatumumab – KESIMPTA (CAP) – EMA/PSUR/0000317682 .......................................... 30
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6.1.31. Retifanlimab – ZYNYZ (CAP) – EMA/PSUR/0000317673 ................................................ 31
6.1.32. Rezafungin – REZZAYO (CAP) – EMA/PSUR/0000317633 .............................................. 31
6.1.33. Ritonavir – NORVIR (CAP) – EMA/PSUR/0000317692 ................................................... 31
6.1.34. Ruxolitinib – OPZELURA (CAP) – EMA/PSUR/0000317686 ............................................. 31
6.1.35. Serplulimab – HETRONIFLY (CAP) – EMA/PSUR/0000317684 ........................................ 31
6.1.36. Sotatercept – WINREVAIR (CAP) – EMA/PSUR/0000317685 .......................................... 31
6.1.37. Spesolimab – SPEVIGO (CAP) – EMA/PSUR/0000317676 .............................................. 32
6.1.38. Tasonermin – BEROMUN (CAP) – EMA/PSUR/0000317660 ............................................ 32
6.1.39. Tenecteplase – METALYSE (CAP) – EMA/PSUR/0000317658 .......................................... 32
6.1.40. Tisotumab vedotin – TIVDAK (CAP) – EMA/PSUR/0000317687 ...................................... 32
6.1.41. Vemurafenib – ZELBORAF (CAP) – EMA/PSUR/0000317646 .......................................... 32
6.1.42. Vernakalant – BRINAVESS (CAP) – EMA/PSUR/0000317649 .......................................... 33
6.1.43. Vibegron – OBGEMSA (CAP) – EMA/PSUR/0000317679 ................................................ 33
6.1.44. Zilucoplan – ZILBRYSQ (CAP) – EMA/PSUR/0000317635 .............................................. 33
6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products
(CAPs) and nationally authorised products (NAPs) .............................................. 33
6.2.1. Atropine sulfate – RYJUNEA (CAP); NAP – EMA/PSUR/0000317677 ................................ 33
6.2.2. Budesonide / Formoterol – BIRESP SPIROMAX (CAP); DUORESP SPIROMAX (CAP); Budesonide
/ Formoterol fumarate dihydrate – GORESP DIGIHALER (CAP); NAP – EMA/PSUR/0000317659
............................................................................................................................. 33
6.2.3. Octocog alfa – ADVATE (CAP); KOVALTRY (CAP); NAP – EMA/PSUR/0000317640 ............ 34
6.2.4. Trientine – CUFENCE (CAP); CUPRIOR (CAP); NAP – EMA/PSUR/0000317661 ................. 34
6.3. PSUR single assessment (PSUSA) procedures including nationally authorised
products (NAPs) only ........................................................................................... 34
6.3.1. Biperiden – EMA/PSUR/0000317634 .......................................................................... 34
6.3.2. Clonidine – EMA/PSUR/0000317638 ........................................................................... 34
6.3.3. Drospirenone / ethinylestradiol – EMA/PSUR/0000317652 ............................................ 34
6.3.4. Finasteride – EMA/PSUR/0000317641 ........................................................................ 35
6.3.5. Fluocinolone acetonide (intravitreal implant in applicator) – EMA/PSUR/0000317680 ....... 35
6.3.6. Hexoprenaline sulfate – EMA/PSUR/0000317650 ......................................................... 35
6.3.7. Losartan – EMA/PSUR/0000317642 ........................................................................... 35
6.3.8. Meclozine – EMA/PSUR/0000317667 .......................................................................... 35
6.3.9. Metronidazole / neomycin / nystatin – EMA/PSUR/0000317665 ..................................... 35
6.3.10. Nifedipine – EMA/PSUR/0000317647 .......................................................................... 36
6.3.11. Poractant alfa – EMA/PSUR/0000317645 .................................................................... 36
6.3.12. Povidone, polyvinyl alcohol / povidone – EMA/PSUR/0000317643 .................................. 36
6.3.13. Raltitrexed – EMA/PSUR/0000317648 ........................................................................ 36
6.4. Follow-up to PSUR/PSUSA procedures ................................................................. 36
6.5. Variation procedure(s) resulting from PSUSA evaluation ..................................... 36
6.5.1. Natalizumab – TYSABRI (CAP) – EMA/VR/0000315289 ................................................. 36
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6.6. Expedited summary safety reviews ...................................................................... 37
7. Post-authorisation safety studies (PASS) 37
7.1. Protocols of PASS imposed in the marketing authorisation(s) .............................. 37
7.1.1. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) –
EMA/PASS/0000328042 ........................................................................................... 37
7.1.2. Sodium valproate (NAP) – EMA/PASS/0000328174 ...................................................... 37
7.2. Protocols of PASS non-imposed in the marketing authorisation(s) ...................... 38
7.2.1. Chikungunya vaccine (recombinant, adsorbed) – VIMKUNYA (CAP) – EMA/PAM/000027644738
7.2.2. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000325493 .............................................. 38
7.2.3. Vamorolone – AGAMREE (CAP) – EMA/PAM/0000274869 .............................................. 38
7.3. Results of PASS imposed in the marketing authorisation(s) ................................. 38
7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s) ..... 39
7.4.1. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000302705 .......................... 39
7.4.2. Elosulfase alfa – VIMIZIM (CAP) – EMA/VR/0000268096 .............................................. 39
7.4.3. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000296039 ............................................... 39
7.4.4. Linaclotide – CONSTELLA (CAP) – EMA/VR/0000281586 ............................................... 39
7.5. Interim results and other post-authorisation measures for imposed and non-imposed
studies .................................................................................................................. 40
7.5.1. Clascoterone – WINLEVI (CAP) – EMA/PAM/0000325634 .............................................. 40
7.5.2. Damoctocog alfa pegol – JIVI (CAP) – EMA/PAM/0000324421 ....................................... 40
7.5.3. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000323622 ............................................. 40
7.5.4. Infliximab – REMSIMA (CAP) – EMA/PAM/0000325710 ................................................. 40
7.5.5. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) –
EMA/PAM/0000292603 ............................................................................................. 41
7.5.6. Nirmatrelvir / Ritonavir – PAXLOVID (CAP) – EMA/PAM/0000324414 .............................. 41
7.5.7. Nonacog beta pegol – REFIXIA (CAP) – EMA/PAM/0000323326 ..................................... 41
7.5.8. Rivaroxaban – XARELTO (CAP) – EMA/PAM/0000316572 .............................................. 41
7.5.9. Sebelipase alfa – KANUMA (CAP) – EMA/PAM/0000320327 ........................................... 42
7.5.10. Selexipag – UPTRAVI (CAP) – EMA/PAM/0000309454 ................................................... 42
7.5.11. Vosoritide – VOXZOGO (CAP) – EMA/PAM/0000321452 ................................................ 42
7.5.12. Zanubrutinib – BRUKINSA (CAP) – EMA/PAM/0000319828 ............................................ 42
8. Renewals of the marketing authorisation, conditional renewal and
annual reassessments 42
8.1. Annual reassessments of the marketing authorisation ......................................... 42
8.1.1. Afamelanotide – SCENESSE (CAP) – EMA/S/0000322534 ............................................. 42
8.1.2. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329 ............................................... 43
8.1.3. Histamine dihydrochloride – CEPLENE (CAP) – EMA/S/0000319752 ............................... 43
8.1.4. Maralixibat – LIVMARLI (CAP) – EMA/S/0000317715 .................................................... 43
8.1.5. Tagraxofusp – ELZONRIS (CAP) – EMA/S/0000320819 ................................................. 43
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8.1.6. Vilobelimab – GOHIBIC (CAP) – EMA/S/0000319310 .................................................... 43
8.2. Conditional renewals of the marketing authorisation ........................................... 44
8.2.1. Imlifidase – IDEFIRIX (CAP) – EMA/R/0000327647 ...................................................... 44
8.2.2. Resmetirom – REZDIFFRA (CAP) – EMA/R/0000326759 ................................................ 44
8.2.3. Talquetamab – TALVEY (CAP) – EMA/R/0000327092 .................................................... 44
8.2.4. Teclistamab – TECVAYLI (CAP) – EMA/R/0000327677 .................................................. 44
8.3. Renewals of the marketing authorisation ............................................................. 44
9. Product related pharmacovigilance inspections 44
9.1. List of planned pharmacovigilance inspections ..................................................... 44
9.2. Ongoing or concluded pharmacovigilance inspections .......................................... 45
9.3. Others .................................................................................................................. 45
10. Other safety issues for discussion requested by the Member States,
CHMP or the EMA 45
10.1.1. Αnti-t lymphocyte immunoglobulin for human use, rabbit (NAP) – ES 2026/62650/II/0122, DE
II-2601996-20251223-01, IE/H/xxxx/WS/395, SE/H/xxxx/WS/1162, FR/H/xxxx/WS/627,
DK/H/xxxx/WS/495 ................................................................................................. 45
11. Scientific advice procedures 45
12. Organisational, regulatory and methodological matters 45
12.1. Mandate and organisation of the PRAC ................................................................. 45
12.1.1. PRAC membership ................................................................................................... 45
12.1.2. Nominated proxy ..................................................................................................... 45
12.2. Coordination with EMA Scientific Committees or CMDh-v ..................................... 46
12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups ......... 46
12.4. Cooperation within the EU regulatory network ..................................................... 46
12.4.1. Health threats and EMA Emergency Task Force (ETF) activities - update ......................... 46
12.4.2. PRAC strategic review and learning meeting (SRLM) under the Cyprus presidency of the
European Union (EU) Council – Pafos, Cyprus, 12 – 13 May 2026 - agenda ..................... 46
12.5. Cooperation with International Regulators........................................................... 46
12.6. Contacts of the PRAC with external parties and interaction with the Interested
Parties to the Committee ...................................................................................... 46
12.7. PRAC work plan .................................................................................................... 46
12.8. Planning and reporting ......................................................................................... 46
12.9. Pharmacovigilance audits and inspections ........................................................... 46
12.9.1. Pharmacovigilance systems and their quality systems .................................................. 46
12.9.2. Pharmacovigilance inspections .................................................................................. 47
12.9.3. Pharmacovigilance audits.......................................................................................... 47
12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list ........ 47
12.10.1. Periodic safety update reports ................................................................................... 47
12.10.2. PSURs repository ..................................................................................................... 47
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12.10.3. Union reference date list – consultation on the draft list ............................................... 47
12.11. Signal management .............................................................................................. 47
12.12. Adverse drug reactions reporting and additional reporting .................................. 47
12.12.1. Management and reporting of adverse reactions to medicinal products ........................... 47
12.12.2. Additional monitoring ............................................................................................... 47
12.12.3. List of products under additional monitoring – consultation on the draft list .................... 47
12.12.4. Good Pharmacovigilance Practice (GVP) module VI on Management and reporting of adverse
reactions to medicinal products - revision ................................................................... 47
12.13. EudraVigilance database ...................................................................................... 48
12.13.1. Activities related to the confirmation of full functionality ............................................... 48
12.14. Risk management plans and effectiveness of risk minimisations ......................... 48
12.14.1. Risk management systems ....................................................................................... 48
12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations .......... 48
12.15. Post-authorisation safety studies (PASS) ............................................................. 48
12.15.1. Post-authorisation Safety Studies – imposed PASS ...................................................... 48
12.15.2. Post-authorisation Safety Studies – non-imposed PASS ................................................ 48
12.16. Community procedures ......................................................................................... 48
12.16.1. Referral procedures for safety reasons ....................................................................... 48
12.17. Renewals, conditional renewals, annual reassessments ....................................... 48
12.18. Risk communication and transparency ................................................................. 48
12.18.1. Public participation in pharmacovigilance .................................................................... 48
12.18.2. Safety communication .............................................................................................. 49
12.19. Continuous pharmacovigilance ............................................................................. 49
12.19.1. Incident management .............................................................................................. 49
12.20. Impact of pharmacovigilance activities ................................................................ 49
12.20.1. Strategy on measuring the impact of pharmacovigilance – PRAC interest group (IG) Impact -
Annual activity report 2025 ....................................................................................... 49
12.21. Others .................................................................................................................. 49
12.21.1. Guideline on risk assessment of medicinal products on human reproduction and lactation: from
data to labelling ...................................................................................................... 49
13. Any other business 49
14. Explanatory notes 49
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 9/50
1. Introduction
1.1. Welcome and declarations of interest of members, alternates and
experts
Pre-meeting list of participants and restrictions in relation to declarations of interests
applicable to the items of the agenda for the PRAC plenary session to be held 07-10 April
2026. See April month 2026 PRAC minutes (to be published post May 2026 PRAC meeting).
1.2. Agenda of the meeting on 07-10 April 2026
Action: For adoption
1.3. Minutes of the previous meeting on 09-12 March 2026
Action: For adoption
2. EU referral procedures for safety reasons: urgent EU
procedures
2.1. Newly triggered procedures
None
2.2. Ongoing procedures
None
2.3. Procedures for finalisation
None
3. EU referral procedures for safety reasons: other EU referral
procedures
3.1. Newly triggered procedure
None
3.2. Ongoing procedures
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 10/50
3.3. Procedures for finalisation
None
3.4. Re-examination procedures1
None
3.5. Others
None
4. Signals assessment and prioritisation2
4.1. New signals detected from EU spontaneous reporting systems
and/or other sources
4.1.1. Binimetinib - MEKTOVI (CAP); Encorafenib – BRAFTOVI (CAP)
Applicant: Pierre Fabre Medicament
PRAC Rapporteur: To be appointed
Scope: Signal of neutropenia, febrile neutropenia
Action: For adoption of PRAC recommendation
EPITT 20255 – New signal
Lead Member State(s): LT, PT
4.2. Signals follow-up and prioritisation
4.2.1. Axicabtagene ciloleucel – YESCARTA (CAP) - EMEA/H/C/002695/SDA/019;
lisocabtagene maraleucel – BREYANZI (CAP) - EMEA/H/C/002695/SDA/025
Applicants: Bristol-Myers Squibb Pharma EEIG (Breyanzi), Kite Pharma EU B.V. (Yescarta),
ATMP
PRAC Rapporteur: Karin Erneholm
Scope: Signal of increased risk of brain oedema in primary mediastinal large B-cell
lymphoma (PMBCL) patients
Action: For adoption of PRAC recommendation
EPITT 20224 – Follow-up to December 2025
1 Re-examination of PRAC recommendation under Article 32 of Directive 2001/83/EC
2 Each signal refers to a substance or therapeutic class. The route of marketing authorisation is indicated in brackets (CAP for
Centrally Authorised Products; NAP for Nationally Authorised Products including products authorised via Mutual Recognition
Procedures and Decentralised Procedure). Product names are listed for reference Centrally Authorised Products (CAP) only.
PRAC recommendations will specify the products concerned in case of any regulatory action required
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 11/50
4.2.2. Ponatinib - ICLUSIG (CAP) - EMEA/H/C/002695/SDA/019
Applicant: Incyte Biosciences Distribution B.V.
PRAC Rapporteur: Mari Thorn
Scope: Signal of congenital megacolon, maternal exposure during pregnancy
Action: For adoption of PRAC recommendation
EPITT 20231 – Follow-up to December 2025
4.2.3. Tirzepatide - MOUNJARO (CAP); MOUNJARO KWIKPEN (CAP) -
EMEA/H/C/005620/SDA/007
Applicant: Eli Lilly Nederland B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Signal of drug interaction with warfarin and other coumarin derivatives leading to
international normalised ratio decreased
Action: For adoption of PRAC recommendation
EPITT 20198 – Follow-up to October 2025
4.3. Variation procedure(s) resulting from signal evaluation
None
5. Risk management plans (RMPs)
5.1. Medicines in the pre-authorisation phase
5.1.1. Catequentinib (CAP MAA) - EMEA/H/C/006317, Orphan
Scope (pre D-180 phase): Treatment of synovial sarcoma or leiomyosarcoma
Action: For adoption
5.1.2. Denosumab (CAP MAA) - EMEA/H/C/006626
Scope (pre D-180 phase): Prevention of skeletal related events and treatment of giant cell
tumour of bone
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 12/50
5.1.3. Ensitrelvir (CAP MAA) - EMEA/H/C/006063
Scope (pre D-180 phase): Treatment of coronavirus disease 2019 (COVID-19)
Action: For adoption
5.1.4. Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated
(CAP MAA) - EMEA/H/C/006692
Scope (pre D-180 phase): Prophylaxis of influenza
Action: For adoption
5.1.5. Insulin efsitora alfa (CAP MAA) - EMEA/H/C/006388
Scope (pre D-180 phase): Treatment of type 2 diabetes mellitus
Action: For adoption
5.1.6. Leriglitazone (CAP MAA) - EMEA/H/C/006693, Orphan
Scope (pre D-180 phase): Treatment of adrenoleukodystrophy
Action: For adoption
5.1.7. Levodopa / Carbidopa (CAP MAA) - EMEA/H/C/006629
Scope (pre D-180 phase): Treatment of adult patients with Parkinson’s disease
Action: For adoption
5.1.8. Narsoplimab (CAP MAA) - EMEA/H/C/005247, Orphan
Scope (pre D-180 phase): Treatment of patients with haemopoietic stem cell transplant-
associated thrombotic microangiopathy.
Action: For adoption
5.1.9. Norucholic acid (CAP MAA) - EMEA/H/C/006515, Orphan
Scope (pre D-180 phase): Treatment of primary sclerosing cholangitis (PSC) in adults.
Action: For adoption
5.2. Medicines in the post-authorisation phase – PRAC-led procedures
5.2.1. Bosentan – STAYVEER (CAP); TRACLEER (CAP) – EMA/VR/0000316336
Applicant: Janssen Cilag International
PRAC Rapporteur: Zoubida Amimour
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 13/50
Scope: Submission of an updated RMP version 12 for TRACLEER and STAYVEER to remove
the Liver Safety Update Report (LSUR) as a routine pharmacovigilance activity for the
important identified risk of hepatotoxicity. The Annex II is updated accordingly. In addition,
the MAH is updating the list of safety concerns in line with requests from the PRAC in their
assessment report for procedure PSUSA/00000425/202411.
Action: For adoption
5.2.2. Carfilzomib – KYPROLIS (CAP) – EMA/VR/0000325402
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Barbara Kovacic Bytyqi
Scope: Submission of an updated RMP version 13.0 in order to remove important identify
risks from the list of safety concerns following PSUSA procedure
EMEA/H/C/PSUSA/00010448/202207.
Action: For adoption
5.2.3. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000291534
Applicant: Roche Registration GmbH
PRAC Rapporteur: Dirk Mentzer
Scope: Submission of an updated RMP version 13.0 in order to add non-infectious colitis as
an important potential risk along with an additional pharmacovigilance activity in the form of
a voluntary Category 3 non-interventional post-authorization study to further characterize
this risk.
Action: For adoption
5.3. Medicines in the post-authorisation phase – CHMP-led procedures
5.3.1. Afamelanotide – SCENESSE (CAP) – EMA/VR/0000325360
Applicant: Clinuvel Europe Limited
PRAC Rapporteur: Dennis Lex
Scope: Submission of the final report from study CUV052 listed as a category 3 study in the
RMP. This is a phase II study to evaluate the pharmacokinetics of afamelanotide in patients
with erythropoietic protoporphyria. The RMP version 11 has also been submitted.
Action: For adoption
5.3.2. Alpelisib – PIQRAY (CAP) – EMA/VR/0000317159
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Bianca Mulder
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 14/50
Scope: Extension of indication for PIQRAY in combination with fulvestrant for the treatment
of postmenopausal women, and men, with hormone receptor (HR)‑positive, human epidermal
growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer with
a PIK3CA mutation after disease progression following an endocrine-based regimen; based
on the primary analysis (DCO 15-Oct-2024) from the Phase III Study CBYL719C2303
(C2303, EPIK-B5). This is a Phase III, randomized, double-blind, placebo-controlled study of
alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with
HR-positive, HER2-negative advanced breast cancer with PIK3CA mutation, who progressed
on or after aromatase inhibitor and a CDK4/6 inhibitor. As a consequence, sections 4.2, 4.4,
4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance.
Version 10.0 of the RMP has also been submitted.
Action: For adoption
5.3.3. Atogepant – AQUIPTA (CAP) – EMA/VR/0000310717
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Rugile Pilviniene
Scope: A grouped application comprised of 1 Type II Variation and 3 Type I Variations, as
follows:
Type II (C.I.6): Extension of indication to include acute treatment of migraine with or without
aura in adults, based on interim results from study M24-305; this is a 24-week, global, Phase
3, multicenter, randomized, double blind, placebo-controlled, multiple-migraine attack study
with an open label period to evaluate the safety and efficacy of atogepant in adult
participants for the acute treatment of migraine (ECLIPSE). As a consequence, sections 4.1,
4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance.
Version 2.2 of the RMP has also been submitted.
Action: For adoption
5.3.4. Axicabtagene ciloleucel – YESCARTA (CAP); Brexucabtagene autoleucel –
TECARTUS (CAP) – EMA/VR/0000308229
Applicant: Kite Pharma EU B.V.
PRAC Rapporteur: Karin Erneholm
Scope: Update of sections 4.2, 4.4, 4.5. 4.7 and 6.4 of the SmPC in order to modify the pre-
and post-infusion monitoring recommendations and requirements related to the risk of CRS
(cytokine release syndrome) and ICANS (immune effector cell-associated neurotoxicity
syndrome) based on data from clinical trials, post-marketing experience and literature. The
Package Leaflet is updated accordingly. The RMP version 7.1 has also been submitted. In
addition, Annex II has been updated accordingly. Furthermore, the MAH took the opportunity
to update the list of local representatives in the Package Leaflet, to bring the PI in line with
the latest QRD template version 10.4 and to implement editorial changes to the PI.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 15/50
5.3.5. Berotralstat – ORLADEYO (CAP) – EMA/X/0000268892
Applicant: Biocryst Ireland Limited
PRAC Rapporteur: Julia Pallos
Scope: Extension application to introduce a new pharmaceutical form associated with new
strengths (78 mg, 96 mg, 108 and 132 film - coated granules). The new presentations are
indicated to include treatment for paediatric patients aged 2 to less than 12 years. The
extension application is grouped with a type II clinical variation (C.I.4). As a consequence,
sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet and
Labelling are updated in accordance. Version 2.1 of the RMP has also been submitted.
Action: For adoption
5.3.6. Capivasertib – TRUQAP (CAP) – EMA/VR/0000293735
Applicant: AstraZeneca AB
PRAC Rapporteur: Sonja Radowan
Scope: Extension of indication to include Truqap in combination with abiraterone for the
treatment of metastatic castration-sensitive prostate cancer characterized by PTEN deficient
tumours based on non-clinical and clinical dataset, including interim results from the pivotal
study D361BC00001 (CAPItello-281); this is a Phase III double-blind, randomised, placebo-
controlled study assessing the efficacy and safety of capivasertib + abiraterone versus
placebo + abiraterone as treatment for patients with de novo metastatic hormone-sensitive
prostate cancer (mHSPC) characterised by PTEN deficiency; As a consequence, sections 4.1,
4.2, 4.4, 4.8, 5.1, 5.2 and 5.3 of the SmPC are updated. The Package Leaflet is updated in
accordance. Version 3.1 of the RMP has also been submitted. As part of the application, the
MAH is requesting a 1-year extension of the market protection.
Action: For adoption
5.3.7. Ceftolozane / Tazobactam – ZERBAXA (CAP) – EMA/VR/0000320716
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: A grouped application comprised of two Type II Variations, as follows:
C.I.6: Extension of indication to include treatment of hospital-acquired pneumonia (HAP),
including ventilator-associated pneumonia (VAP), in paediatric patients from birth to less
than 18 years of age for ZERBAXA, based on the final results from study MK-7625A-036. This
is a Phase 1, open-label, non-comparative, multicentre clinical study to evaluate the safety,
tolerability, and pharmacokinetics of ceftolozane/tazobactam in paediatric participants with
nosocomial pneumonia. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 6.6 of the
SmPC are updated. The Package Leaflet is updated accordingly.
C.I.4: Update of sections 4.2 and 5.2 of the SmPC in order to include dosing
recommendations for paediatric patients with impaired renal function, for the indications of
complicated Intra-Abdominal Infections (cIAI), Acute pyelonephritis (AP) and complicated
Urinary Tract Infections (cUTI), based on an M&S analysis integrating adult and pediatric
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 16/50
data sources as described in M&S report "Population pharmacokinetic and probability of
target attainment analyses of MK-7625A (ZERBAXA) in pediatric patients in support of
nosocomial pneumonia"
Version 4.1 of the RMP has also been submitted. In addition, the Marketing authorisation
holder (MAH) took the opportunity to update the list of local representatives in the Package
Leaflet. Furthermore, section 5.1 “Susceptibility testing breakpoints” in the SmPC has been
brought in line with the Guideline on the evaluation of medicinal products indicated for
treatment of bacterial infections.
Action: For adoption
5.3.8. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000320534
Applicant: BioNTech Manufacturing GmbH
PRAC Rapporteur: Liana Martirosyan
Scope: A grouped application consisting of:
C.I.6.a. To modify the approved therapeutic indication by extending from COMIRNATY
concentrate for dispersion for injection formulation to Comirnaty dispersion for injection
formulation as well as the overall change of posology from 3mcg to 10mcg and dosing
regimen simplification (i.e. from 3-dose to a 2-dose primary course for 6 months to <2 years
of age and to a single dose for 2 years to <5 years of age) for the active immunization to
prevent COVID-19 caused by SARS-CoV-2 in infants and children from 6 months to <5 years
without history of completion of COVID-19 primary series based on sub-study A (SSA) phase
2/3 Groups 1-5 of study C4591048 as well as to support the approved 10mcg single dose
simplified posology in vaccine-naïve children from 5 to 11 years of age based on substudy E
(SSE) of study C4591048, listed as a category 3 study in the RMP. As consequence, sections
1, 2, 3, 4.1, 4.2, 4.8, 5.1, 6.5, 6.6 and 8 of the SmPC and sections 1, 2, 3, 4 and 6 of the PL
are updated accordingly. Study C4591048 is a master phase 1/2/3 protocol to investigate the
safety, tolerability, and immunogenicity of variant adapted BNT162b2 RNA – based vaccine
candidate(s) in healthy children. The updated RMP version 15.2 has also been submitted. In
addition, the MAH took the opportunity to implement minor editorial changes in the PI.
C.I.7.b. To delete the 3mcg strength from the Comirnaty Marketing authorisation
(EU/1/20/1528/035-036, EU/1/20/1528/042, EU/1/20/1528/050).
Action: For adoption
5.3.9. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (CAP) – EMA/X/0000314697
Applicant: International Partnership For Microbicides
PRAC Rapporteur: Jan Neuhauser
Scope: Extension application to add a new strength of 100 mg for dapivirine vaginal delivery
system, for vaginal use grouped with a type IA variation (A.2.a) to change the (invented)
name of the medicinal product from ‘Dapivirine Vaginal Ring 25 mg’ to ‘Dapivirine Vaginal
Ring’. The RMP (version 2.1) is updated in accordance.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 17/50
5.3.10. Decitabine / Cedazuridine – INAQOVI (CAP) – EMA/VR/0000304730
Applicant: Otsuka Pharmaceutical Netherlands B.V.
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Extension of indication to include treatment of adult patients with newly diagnosed
acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy for
INAQOVI in combination with venetoclax, based on interim results from study ASTX727-07;
this is a single-arm, open-label pharmacokinetic, safety, and efficacy study of ASTX727 in
combination with venetoclax in adult patients with acute myeloid leukemia; As a
consequence, sections 4.1, 4.2, 4.8, 5.1, and 5.2 of the SmPC are updated. The Package
Leaflet is updated in accordance. Version 1.3 of the RMP has also been submitted. In
addition, the Marketing authorisation holder (MAH) took the opportunity to update the list of
local representatives in the Package Leaflet and bring editiorial changes to the PI. As part of
the application, the MAH is requesting a 1-year extension of the market protection.
Action: For adoption
5.3.11. Deucravacitinib – SOTYKTU (CAP) – EMA/VR/0000309456
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: Update of sections 4.6, 5.2 and 5.3 of the SmPC based on final results from study
IM011-1123. This is a Phase 4, open-label, single-group, single-dose study evaluating
deucravacitinib concentrations in the breast milk and plasma of healthy lactating female
subjects. The updated RMP (version 4.0) has also been submitted.
Action: For adoption
5.3.12. Evolocumab – REPATHA (CAP) – EMA/VR/0000322435
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Kimmo Jaakkola
Scope: Extension of indication to extend the indication for REPATHA to include adults at high
risk for a first cardiovascular event, based on the final results from study 20170625
(VESALIUS); this is a Phase 3, double-blind, randomized, placebo-controlled, multicenter
study to evaluate the impact of evolocumab on major cardiovascular events in patients at
high cardiovascular risk without prior myocardial infarction or stroke. As a consequence,
sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in
accordance. Version 9.0 of the RMP has also been submitted. In addition, the Marketing
authorisation holder (MAH) took the opportunity to update the list of local representatives in
the Package Leaflet. Furthermore, some typographical errors were corrected, and the PI is
brought in line with the latest QRD template version.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 18/50
5.3.13. Fedratinib – INREBIC (CAP) – EMA/VR/0000324950
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Sonja Radowan
Scope: A grouped application consisting of:
C.4. Update of sections 4.4, 4.8, and 5.1 of the SmPC in order to update clinical
pharmacology, efficacy and safety information based on final results from study FEDR MF 002
listed as a category 3 study in the RMP; this is a phase 3, multicenter, open-label,
randomized study to evaluate the efficacy and safety of fedratinib compared to best available
therapy in subjects with DIPSS-intermediate or high-risk primary myelofibrosis, post-
polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and
previously treated with ruxolitinib; the Package Leaflet is updated accordingly. The RMP
version 4.0 has also been submitted.
C.3. Update of section 4.8 of the SmPC in order to add subdural hematoma to the list of
adverse drug reactions (ADRs) following recommendation of PSUSA
PSUSA/00010909/202508.
Action: For adoption
5.3.14. Human normal immunoglobulin – PRIVIGEN (CAP) – EMA/VR/0000304719
Applicant: CSL Behring GmbH
PRAC Rapporteur: Dirk Mentzer
Scope: A grouped application consisting of:
C.I.6: Extension of indication to include treatment of patients with measles pre/post-
exposure prophylaxis in whom active immunisation is contraindicated or not advised, for
PRIVIGEN, in alignment with the IVIg core SmPC (EMA/CHMP/BPWP/94038/2007 Rev); As a
consequence, sections 2, 4.1, 4.2 and 5.2 of the SmPC. The Package Leaflet is updated
accordingly. The RMP version 9 has also been submitted.
Action: For adoption
5.3.15. Influenza vaccine (live, nasal) – FLUENZ (CAP) – EMA/VR/0000302352
Applicant: AstraZeneca AB
PRAC Rapporteur: Jean-Michel Dogné
Scope: Update of sections 4.2 and 4.4 of the SmPC in order to introduce self-administration
instructions based on postmarketing data and literature. The Package Leaflet and Labelling
updated accordingly. The RMP version 13.1 has also been submitted. In addition, the MAH
took the opportunity to bring the PI in line with the latest QRD template version 10.4.
Action: For adoption
5.3.16. Insulin icodec / Semaglutide – KYINSU (CAP) – EMA/VR/0000322527
Applicant: Novo Nordisk A/S
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 19/50
PRAC Rapporteur: Petar Mas
Scope: Extension of indication to include treatment of adults with insufficiently controlled
type 2 diabetes mellitus as an adjunct to diet and exercise for KYINSU, based on results from
the Phase 3b study NN1535-4988 (COMBINE 4); this is a 40-week study comparing the
efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL in
participants with type 2 diabetes inadequately controlled on oral anti-diabetic drugs. As a
consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package
Leaflet is updated in accordance. Version 1.1 of the RMP has also been submitted. In
addition, the Marketing authorisation holder (MAH) took the opportunity to introduce minor
editorial changes to the PI.
Action: For adoption
5.3.17. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) –
EMA/VR/0000327431
Applicant: Bristol-Myers Squibb Pharma EEIG, ATMP
PRAC Rapporteur: Dirk Mentzer
Scope: Submission of the final report from study CA082-1105 listed as a Specific Obligation
in the Annex II of the Product Information. This is a non-interventional study submitted to
summarize the consistency of Breyanzi product batch quality data measured at the time of
release and clinical outcomes in patients treated with Breyanzi in the post-marketing setting
for R/R LBCL within the approved indications and dose range per the EU PI. The Annex II and
the RMP version 10.0 are updated accordingly. In addition, the MAH took the opportunity to
make a minor editorial update by removing some grey shading from Annex III.
Action: For adoption
5.3.18. Mavacamten – CAMZYOS (CAP) – EMA/VR/0000294573
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Kimmo Jaakkola
Scope: A grouped application consisting of:
C.I.4: Update of section 4.2 of the SmPC in order to remove the Week 8 echocardiography
monitoring and associated down-titration opportunity based on the modelling and simulation
analyses along with safety data from two studies conducted in Japan (HORIZON-HCM;
CV027004) and China (EXPLORER-CN; CV0271097/LB2001301). The updated RMP version
7.0 has also been submitted.
C.I.4: Update of sections 4.2, and 4.5 of the SmPC in order to modify maximum dose
requirement from 5 mg to 15 mg for CYP2C19 poor metabolisers (PM), in alignment with the
requirement for non-PM based on the modelling and simulation analyses along with safety
data from two studies conducted in Japan (HORIZON-HCM; CV027004) and China
(EXPLORER-CN; CV0271097/LB2001301). The updated RMP version 7.0 has also been
submitted.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
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5.3.19. Naloxone – NYXOID (CAP) – EMA/VR/0000325329
Applicant: Mundipharma Corporation (Ireland) Limited
PRAC Rapporteur: Liana Martirosyan
Scope: Change in the legal status of Nyxoid from ‘medicinal product subject to medical
prescription’ to ‘medicinal products not subject to medical prescription’.
Action: For adoption
5.3.20. Nivolumab – OPDIVO (CAP) – EMA/VR/0000304938
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Dirk Mentzer
Scope: Extension of indication to include OPDIVO for the treatment of adults and adolescents
12 years of age and older with previously untreated Stage III or IV classical Hodgkin
Lymphoma (cHL), based on results from the pivotal study CA2098UT (SWOG 1826), a Phase
3, randomized, open-label study of nivolumab (Opdivo) + AVD (N-AVD) versus brentuximab
vedotin (Adcetris) + AVD (Bv-AVD) in patients (age ≥12 years) with newly diagnosed,
advanced stage cHL. As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are
updated. The Package Leaflet is updated in accordance. Version 51.0 of the RMP has also
been submitted.
Action: For adoption
5.3.21. Pandemic influenza vaccine (H5N1) (live attenuated, nasal) – PANDEMIC
INFLUENZA VACCINE H5N1 ASTRAZENECA (CAP) – EMA/VR/0000321324
Applicant: AstraZeneca AB
PRAC Rapporteur: Sonja Radowan
Scope: Extension of indication to remove the upper age limit from the indication for
Pandemic influenza vaccine (H5N1) (live, nasal), based on efficacy and safety data previously
submitted in the Marketing Authorisation Application (MAA). As a consequence, sections 4.1,
4.2, 4.4, 4.5, 4.6, 4.8, 5.1, and 5.3 of the SmPC are updated. The Annex II and the Package
Leaflet are updated in accordance. Version 2.2 of the RMP has also been submitted. In
addition, the Marketing authorisation holder (MAH) took the opportunity to introduce editorial
changes throughout the PI and update the list of local representatives in the Package Leaflet.
Action: For adoption
5.3.22. Risankizumab – SKYRIZI (CAP) – EMA/X/0000296763
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Liana Martirosyan
Scope: Extension application to introduce a new strength of 55 mg solution for injection
grouped with a type II variation C.I.6.a to include treatment of paediatric plaque psoriasis (6
to < 18 years) for Skyrizi, based on final results from study M19-977 and interim results
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 21/50
from study M19-973. M19-977 is a randomized, active-controlled, efficacy assessor-blinded
study to evaluate pharmacokinetics, safety, and efficacy of risankizumab in patients from 6
to less than 18 years of age with moderate to severe plaque psoriasis; M19-973 is a phase 3
multicenter, single-arm, open-label extension study to assess the safety, tolerability, and
efficacy of risankizumab in subjects with moderate to severe plaque psoriasis who have
completed participation in study M19-977. As a consequence, sections 1, 2, 3, 4.1, 4.2, 4.4,
4.8, 5.1, 5.2, 6.1, 6.4, 6.5, 6.6, and 8 of the SmPC are updated. The Package Leaflet and
Labelling are updated in accordance. Version 7.0 of the RMP has also been submitted.
Action: For adoption
5.3.23. Sacituzumab govitecan – TRODELVY (CAP) – EMA/VR/0000320818
Applicant: Gilead Sciences Ireland Unlimited Company
PRAC Rapporteur: Bianca Mulder
Scope: Extension of indication to include Trodelvy, in combination with pembrolizumab, for
the treatment of adult patients with unresectable locally advanced or metastatic TNBC who
have not received prior systemic therapy for metastatic disease and whose tumours express
PD-L1 with a combined positive score (CPS) ≥ 10, based on results from study GS-US-592-
6173 (ASCENT-04), which is a phase 3 study of sacituzumab govitecan (IMMU-132) and
Pembrolizumab versus treatment of physician’s choice and Pembrolizumab in patients with
previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer,
whose tumors express PD-L1. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of
the SmPC are updated. The Package Leaflet is updated in accordance. Version 4.2 of the RMP
has also been submitted.
Action: For adoption
5.3.24. Semaglutide – WEGOVY (CAP) – EMA/X/0000296344
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Mari Thorn
Scope: Extension application to introduce a new pharmaceutical form (tablet), associated
with four new strengths (1.5 mg, 4 mg, 9mg and 25 mg) and a new route of administration
(oral use).
Action: For adoption
5.3.25. Semaglutide – WEGOVY (CAP) – EMA/VR/0000327359
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Mari Thorn
Scope: Update of sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC in order to reflect
clinical results related to adults with overweight/obesity and metabolic dysfunction-
associated steatohepatitis (MASH) based on interim results from phase 3a clinical study
NN9931-4553 (ESSENCE) as well as three additional clinical trials NN9931-4381, NN9931-
4296 and NN9931-4492 in adults with metabolic dysfunction-associated steatotic liver
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 22/50
disease and/or MASH; supportive non-clinical results have also been submitted. The Package
Leaflet is updated accordingly. The RMP version 10.2 has also been submitted.
Action: For adoption
5.3.26. Teclistamab – TECVAYLI (CAP) – EMA/VR/0000322279
Applicant: Janssen Cilag International
PRAC Rapporteur: Veronika Macurova
Scope: Extension of indication to include in combination with daratumumab treatment of
adult patients with relapsed or refractory multiple myeloma who have received at least one
prior therapy for TECVAYLI, based on interim analysis data from the pivotal study MajesTEC-
3 (64007957MMY3001). This is an on-going multicentre, randomised, open-label, Phase 3
study to determine whether adding teclistamab to daratumumab (Tec-Dara) is more
efficacious than adding pomalidomide/dexamethasone (DPd) or bortezomib/dexamethasone
(DVd) to daratumumab in participants with multiple myeloma who previously received 1 to 3
prior line(s) of therapy. As a consequence, sections 4.1, 4.2, 4.4, 4.7, 4.8, 5.1, 5.2 and 6.6
of the SmPC are updated. The Package Leaflet is updated accordingly. References to the
conditional MA have been removed throughout the document. Additionally, the MAH took the
opportunity to update the latest renewal date in section 9 of the SmPC, the list of local
representatives in the Package Leaflet and made editorial changes throughout. And updated
RMP version 6.1 has been submitted. As part of the application, the MAH is requesting a 1-
year extension of the market protection.
Action: For adoption
5.3.27. Tedizolid phosphate – SIVEXTRO (CAP) – EMA/X/0000282136
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Extension application to introduce a new pharmaceutical form (powder for oral
suspension, 200 mg). The RMP (version 8.1) is updated in accordance. Additionally, the
marketing authorisation holder took the opportunity to align the PI with the latest QRD
template.
Action: For adoption
5.3.28. Tezepelumab – TEZSPIRE (CAP) – EMA/VR/0000321455
Applicant: AstraZeneca AB
PRAC Rapporteur: Eva Jirsová
Scope: Grouped application comprised of two Type II Variations, as follows:
C.I.13: Submission of the report from study D5180C00024 (SUNRISE) listed as a category 3
study in the RMP. This is a randomised, double-blind, parallel-group, placebo-controlled 28-
week phase 3 efficacy and safety study of tezepelumab in reducing oral corticosteroid use in
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 23/50
adults with oral corticosteroid dependent asthma. The RMP version 7 has also been updated
accordingly.
C.I.11: Submission of an updated RMP version 7 in order to add study D5241C00006
(EMBARK) and study D5241C00007 (JOURNEY) as additional pharmacovigilance activities to
further characterize the important potential risks: “Serious infections” and “Malignancies”.
Action: For adoption
5.3.29. Tolvaptan – JINARC (CAP) – EMA/VR/0000246866
Applicant: Otsuka Pharmaceutical Netherlands B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: Update of sections 4.2 and 5.1 of the SmPC in order to update information based on
final results from study 156-12-299 listed as a category 1 study in the RMP. This is a 7.5-
year, Multicentre, Non-interventional, Post-authorisation Safety Study for Patients Prescribed
JINARC for Autosomal Dominant Polycystic Kidney Disease. This study was intended to
explore the safety profile and usage of Jinarc when used in the real-world setting in Europe,
particularly with relation to the risk of liver injury. The Package Leaflet is updated
accordingly. The RMP version 15.1 has also been submitted. In addition, the MAH took the
opportunity to update Annex II section D, to update the list of local representatives in the
Package Leaflet and to bring the PI in line with the latest QRD template version 10.4.
Action: For adoption
5.3.30. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000322236
Applicant: Daiichi Sankyo Europe GmbH
PRAC Rapporteur: Carla Torre
Scope: Extension of indication to include the indication first-line treatment of adult patients
with unresectable or metastatic HER2-positive breast cancer for Enhertu (trastuzumab
deruxtecan) in combination with pertuzumab is based on results from the phase 3 DESTINY-
Breast09 study. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 of SmPC are updated and
the Package Leaflet is updated in accordance. Version 10.1 of the RMP has also been
submitted.
Action: For adoption
5.3.31. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000293327
Applicant: Daiichi Sankyo Europe GmbH
PRAC Rapporteur: Carla Torre
Scope: Extension of indication to include treatment of adult patients with unresectable or
metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who
have no satisfactory alternative treatment options for Enhertu, based on pooled pop-PK
analysis and interim results from study D967VC00001 (DESTINY-PanTumor02); this is a
Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 24/50
Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2-expressing Tumors; As a
consequence, sections 4.1, 4.2, 4.8, and 5.1 of the SmPC are updated. The Package Leaflet
is updated in accordance. Version 9.2 of the RMP has also been submitted. In addition, the
Marketing authorisation holder (MAH) took the opportunity to introduce editorial changes to
the PI.
Action: For adoption
5.3.32. Vamorolone – AGAMREE (CAP) – EMA/VR/0000293535
Applicant: Santhera Pharmaceuticals (Deutschland) GmbH
PRAC Rapporteur: Rhea Fitzgerald
Scope: Extension of indication to include treatment of 2 to <4 year olds for AGAMREE, based
on final results from study VBP15-006; this is a phase II open-label, multiple dose study to
assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory
efficacy of vamorolone in boys ages 2 to <4 years and 7 to <18 years with Duchenne
Muscular Dystrophy (DMD) and an updated paediatric extrapolation report referencing 4 to
<7-year-old subjects with DMD from Study VBP15-004, compared to the 2 to <4-year-old
population from Study VBP15-006. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of
the SmPC are updated. The Package Leaflet is updated in accordance. Version 2.0 of the RMP
has also been submitted. In addition, the Marketing authorisation holder took the opportunity
to make some editorial corrections to SmPC.
Action: For adoption
5.3.33. Venetoclax – VENCLYXTO (CAP) – EMA/VR/0000322237
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Eva Jirsová
Scope: Extension of indication to include, in combination with ibrutinib, the treatment of
adult patients with previously untreated chronic lymphocytic leukaemia (CLL) for VENCLYXTO
based on the results of the phase 3 study 54179060CLL3011 (GLOW) and phase 2 study
PCYC-1142-CA (CAPTIVATE). GLOW is a randomized, open-label, phase 3 study of the
combination of ibrutinib plus venetoclax versus chlorambucil plus obinutuzumab for the first-
line treatment of subjects with chronic lymphocytic leukemia (CLL)/small lymphocytic
lymphoma (SLL). CAPTIVATE study is a phase 2, multicenter, international, efficacy and
safety study assessing treatment with venetoclax plus ibrutinib in subjects with chronic
lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). As a consequence, sections
4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in
accordance. Version 11.2 of the RMP has also been submitted. In addition, the Marketing
authorisation holder (MAH) took the opportunity to introduce minor changes to the PI and to
update the list of local representatives in the Package Leaflet.
Action: For adoption
5.3.34. Venetoclax – VENCLYXTO (CAP) – EMA/VR/0000322240
Applicant: Abbvie Deutschland GmbH & Co. KG
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 25/50
PRAC Rapporteur: Eva Jirsová
Scope: Extension of indication to include, in combination with acalabrutinib with or without
obinutuzumab, the treatment of adult patients with previously untreated chronic lymphocytic
leukaemia (CLL) for VENCLYXTO based on the results from the pivotal study ACE-CL-
311/D8221C00001 (AMPLIFY); this is a randomized, multicenter, open-label, Phase 3 study
to compare the efficacy and safety of acalabrutinib (ACP-196) in combination with venetoclax
with and without obinutuzumab compared to investigator’s choice of chemoimmunotherapy
in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53
mutation. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are
updated. The Package Leaflet is updated in accordance. The RMP version 11.1 has also been
submitted.
Action: For adoption
6. Periodic safety update reports (PSURs)
6.1. PSUR single assessment (PSUSA) procedures including centrally
authorised products (CAPs) only
6.1.1. Abrocitinib – CIBINQO (CAP) – EMA/PSUR/0000317674
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Petar Mas
Scope: Evaluation of a PSUSA procedure (PSUSA/00010976/202509)
Action: For adoption
6.1.2. Aprocitentan – JERAYGO (CAP) – EMA/PSUR/0000317689
Applicant: Idorsia Pharmaceuticals Deutschland GmbH
PRAC Rapporteur: Maria del Pilar Rayon
Scope: Evaluation of a PSUSA procedure (PSUSA/00011067/202509)
Action: For adoption
6.1.3. Asenapine – SYCREST (CAP) – EMA/PSUR/0000317636
Applicant: Organon N.V.
PRAC Rapporteur: Ana Sofia Diniz Martins
Scope: Evaluation of a PSUSA procedure (PSUSA/00000256/202508)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 26/50
6.1.4. Bedaquiline – SIRTURO (CAP) – EMA/PSUR/0000317651
Applicant: Janssen Cilag International
PRAC Rapporteur: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00010074/202509)
Action: For adoption
6.1.5. Brentuximab vedotin – ADCETRIS (CAP) – EMA/PSUR/0000317688
Applicant: Takeda Pharma A/S
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010039/202508)
Action: For adoption
6.1.6. Caplacizumab – CABLIVI (CAP) – EMA/PSUR/0000317662
Applicant: Ablynx
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00010713/202508)
Action: For adoption
6.1.7. Cenobamate – ONTOZRY (CAP) – EMA/PSUR/0000317671
Applicant: Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
PRAC Rapporteur: Jo Robays
Scope: Evaluation of a PSUSA procedure (PSUSA/00010921/202509)
Action: For adoption
6.1.8. Crizotinib – XALKORI (CAP) – EMA/PSUR/0000317663
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Tiphaine Vaillant
Scope: Evaluation of a PSUSA procedure (PSUSA/00010042/202508)
Action: For adoption
6.1.9. Damoctocog alfa pegol – JIVI (CAP) – EMA/PSUR/0000317669
Applicant: Bayer AG
PRAC Rapporteur: Bianca Mulder
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 27/50
Scope: Evaluation of a PSUSA procedure (PSUSA/00010732/202508)
Action: For adoption
6.1.10. Dasiglucagon – ZEGALOGUE (SRD3) – EMA/PSUR/0000317683
Applicant: Zealand Pharma A/S
PRAC Rapporteur: Zane Neikena
Scope: Evaluation of a PSUSA procedure (PSUSA/00011078/202508)
Action: For discussion
6.1.11. Deucravacitinib – SOTYKTU (CAP) – EMA/PSUR/0000317694
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Liana Martirosyan
Scope: Evaluation of a PSUSA procedure (PSUSA/00011046/202509)
Action: For adoption
6.1.12. Doravirine – PIFELTRO (CAP) – EMA/PSUR/0000317664
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Ana Sofia Diniz Martins
Scope: Evaluation of a PSUSA procedure (PSUSA/00010729/202508)
Action: For adoption
6.1.13. Doravirine / Lamivudine / Tenofovir disoproxil – DELSTRIGO (CAP) –
EMA/PSUR/0000317666
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Ana Sofia Diniz Martins
Scope: Evaluation of a PSUSA procedure (PSUSA/00010731/202508)
Action: For adoption
6.1.14. Duvelisib – COPIKTRA (SRD4) – EMA/PSUR/0000317672
Applicant: Secura Bio Limited
PRAC Rapporteur: Petar Mas
Scope: Evaluation of a PSUSA procedure (PSUSA/00010939/202509)
3 European Commission (EC) decision on the withdrawal of the marketing authorisation for ZEGALOGUE dated 23 February
2026
4 European Commission (EC) decision on the withdrawal of the marketing authorisation for COPIKTRA dated 16 February 2026
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 28/50
Action: For discussion
6.1.15. Ebola vaccine (Ad26.ZEBOV-GP [recombinant]) – ZABDENO (CAP); Ebola vaccine
(MVA-BN-Filo [recombinant]) – MVABEA (CAP) – EMA/PSUR/0000317690
Applicant: Janssen Cilag International
PRAC Rapporteur: Jean-Michel Dogné
Scope: Evaluation of a PSUSA procedure (PSUSA/00010857/202509)
Action: For adoption
6.1.16. Epcoritamab – TEPKINLY (CAP) – EMA/PSUR/0000317637
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Maria Martinez Gonzalez
Scope: Evaluation of a PSUSA procedure (PSUSA/00000107/202509)
Action: For adoption
6.1.17. Filgotinib – JYSELECA (CAP) – EMA/PSUR/0000317681
Applicant: Alfasigma S.p.A.
PRAC Rapporteur: Petar Mas
Scope: Evaluation of a PSUSA procedure (PSUSA/00010879/202509)
Action: For adoption
6.1.18. Fruquintinib – FRUZAQLA (CAP) – EMA/PSUR/0000317678
Applicant: Takeda Pharmaceuticals International AG Ireland Branch
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00011069/202509)
Action: For adoption
6.1.19. Ganaxolone – ZTALMY (CAP) – EMA/PSUR/0000317639
Applicant: Immedica Pharma AB
PRAC Rapporteur: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00000093/202509)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 29/50
6.1.20. Infliximab – FLIXABI (CAP); INFLECTRA (CAP); REMICADE (CAP); REMSIMA (CAP);
ZESSLY (CAP) – EMA/PSUR/0000317670
Applicants: Janssen Cilag International, Celltrion Healthcare Hungary Kft., Pfizer Europe MA
EEIG, Samsung Bioepis NL B.V., Sandoz GmbH
PRAC Rapporteur: Karin Bolin
Scope: Evaluation of a PSUSA procedure (PSUSA/00010759/202508)
Action: For adoption
6.1.21. Insulin icodec – AWIQLI (CAP) – EMA/PSUR/0000317726
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Sonja Radowan
Scope: Evaluation of a PSUSA procedure (PSUSA/00011053/202508)
Action: For adoption
6.1.22. Lebrikizumab – EBGLYSS (CAP) – EMA/PSUR/0000317693
Applicant: Almirall S.A.
PRAC Rapporteur: Liana Martirosyan
Scope: Evaluation of a PSUSA procedure (PSUSA/00000175/202509)
Action: For adoption
6.1.23. Linaclotide – CONSTELLA (CAP) – EMA/PSUR/0000317653
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00010025/202508)
Action: For adoption
6.1.24. Lorlatinib – LORVIQUA (CAP) – EMA/PSUR/0000317668
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Barbara Kovacic Bytyqi
Scope: Evaluation of a PSUSA procedure (PSUSA/00010760/202509)
Action: For adoption
6.1.25. Influenza vaccine (live, nasal) – FLUENZ (CAP) – EMA/PSUR/0000317656
Applicant: AstraZeneca AB
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 30/50
PRAC Rapporteur: Jean-Michel Dogné
Scope: Evaluation of a PSUSA procedure (PSUSA/00001742/202508)
Action: For adoption
6.1.26. Mecasermin – INCRELEX (CAP) – EMA/PSUR/0000317644
Applicant: Esteve Pharmaceuticals S.A.
PRAC Rapporteur: Terhi Lehtinen
Scope: Evaluation of a PSUSA procedure (PSUSA/00001942/202508)
Action: For adoption
6.1.27. Mepolizumab – NUCALA (CAP) – EMA/PSUR/0000317655
Applicant: Glaxosmithkline Trading Services Limited
PRAC Rapporteur: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00010456/202509)
Action: For adoption
6.1.28. Momelotinib – OMJJARA (CAP) – EMA/PSUR/0000317675
Applicant: Glaxosmithkline Trading Services Limited
PRAC Rapporteur: Mari Thorn
Scope: Evaluation of a PSUSA procedure (PSUSA/00000263/202509)
Action: For adoption
6.1.29. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) –
EMA/PSUR/0000317654
Applicant: Orexigen Therapeutics Ireland Limited
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00010366/202509)
Action: For adoption
6.1.30. Ofatumumab – KESIMPTA (CAP) – EMA/PSUR/0000317682
Applicant: Novartis Europharm Limited
PRAC Rapporteur: Amelia Cupelli
Scope: Evaluation of a PSUSA procedure (PSUSA/00010927/202509)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 31/50
6.1.31. Retifanlimab – ZYNYZ (CAP) – EMA/PSUR/0000317673
Applicant: Incyte Biosciences Distribution B.V.
PRAC Rapporteur: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00011059/202509)
Action: For adoption
6.1.32. Rezafungin – REZZAYO (CAP) – EMA/PSUR/0000317633
Applicant: Mundipharma GmbH
PRAC Rapporteur: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00000221/202509)
Action: For adoption
6.1.33. Ritonavir – NORVIR (CAP) – EMA/PSUR/0000317692
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Liana Martirosyan
Scope: Evaluation of a PSUSA procedure (PSUSA/00002651/202508)
Action: For adoption
6.1.34. Ruxolitinib – OPZELURA (CAP) – EMA/PSUR/0000317686
Applicant: Incyte Biosciences Distribution B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00011052/202509)
Action: For adoption
6.1.35. Serplulimab – HETRONIFLY (CAP) – EMA/PSUR/0000317684
Applicant: Accord Healthcare S.L.U.
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00011112/202509)
Action: For adoption
6.1.36. Sotatercept – WINREVAIR (CAP) – EMA/PSUR/0000317685
Applicant: Merck Sharp & Dohme B.V.
PRAC Rapporteur: Zoubida Amimour
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 32/50
Scope: Evaluation of a PSUSA procedure (PSUSA/00011076/202509)
Action: For adoption
6.1.37. Spesolimab – SPEVIGO (CAP) – EMA/PSUR/0000317676
Applicant: LEO PHARMA A/S
PRAC Rapporteur: Zoubida Amimour
Scope: Evaluation of a PSUSA procedure (PSUSA/00011033/202509)
Action: For adoption
6.1.38. Tasonermin – BEROMUN (CAP) – EMA/PSUR/0000317660
Applicant: Belpharma S.A.
PRAC Rapporteur: Karin Erneholm
Scope: Evaluation of a PSUSA procedure (PSUSA/00002850/202508)
Action: For adoption
6.1.39. Tenecteplase – METALYSE (CAP) – EMA/PSUR/0000317658
Applicant: Boehringer Ingelheim International GmbH
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00002888/202508)
Action: For adoption
6.1.40. Tisotumab vedotin – TIVDAK (CAP) – EMA/PSUR/0000317687
Applicant: Genmab A/S
PRAC Rapporteur: Jo Robays
Scope: Evaluation of a PSUSA procedure (PSUSA/00011127/202509)
Action: For adoption
6.1.41. Vemurafenib – ZELBORAF (CAP) – EMA/PSUR/0000317646
Applicant: Roche Registration GmbH
PRAC Rapporteur: Mari Thorn
Scope: Evaluation of a PSUSA procedure (PSUSA/00009329/202508)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 33/50
6.1.42. Vernakalant – BRINAVESS (CAP) – EMA/PSUR/0000317649
Applicant: Advanz Pharma Limited
PRAC Rapporteur: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00003109/202508)
Action: For adoption
6.1.43. Vibegron – OBGEMSA (CAP) – EMA/PSUR/0000317679
Applicant: Pierre Fabre Medicament
PRAC Rapporteur: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00011068/202509)
Action: For adoption
6.1.44. Zilucoplan – ZILBRYSQ (CAP) – EMA/PSUR/0000317635
Applicant: UCB Pharma
PRAC Rapporteur: Karin Erneholm
Scope: Evaluation of a PSUSA procedure (PSUSA/00000169/202509)
Action: For adoption
6.2. PSUR single assessment (PSUSA) procedures including centrally
authorised products (CAPs) and nationally authorised products
(NAPs)
6.2.1. Atropine sulfate – RYJUNEA (CAP); NAP – EMA/PSUR/0000317677
Applicants: Santen Oy, various
PRAC Rapporteur: Dennis Lex
Scope: Evaluation of a PSUSA procedure (PSUSA/00011142/202508)
Action: For adoption
6.2.2. Budesonide / Formoterol – BIRESP SPIROMAX (CAP); DUORESP SPIROMAX (CAP);
Budesonide / Formoterol fumarate dihydrate – GORESP DIGIHALER (CAP); NAP –
EMA/PSUR/0000317659
Applicants: Teva Pharma B.V., various
PRAC Rapporteur: Marie Louise Schougaard Christiansen
Scope: Evaluation of a PSUSA procedure (PSUSA/00010585/202508)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 34/50
6.2.3. Octocog alfa – ADVATE (CAP); KOVALTRY (CAP); NAP – EMA/PSUR/0000317640
Applicants: Takeda Manufacturing Austria AG, Bayer AG, various
PRAC Rapporteur: Dirk Mentzer
Scope: Evaluation of a PSUSA procedure (PSUSA/00002200/202508)
Action: For adoption
6.2.4. Trientine – CUFENCE (CAP); CUPRIOR (CAP); NAP – EMA/PSUR/0000317661
Applicants: Orphalan, Univar Solutions B.V., various
PRAC Rapporteur: Ana Sofia Diniz Martins
Scope: Evaluation of a PSUSA procedure (PSUSA/00010637/202509)
Action: For adoption
6.3. PSUR single assessment (PSUSA) procedures including nationally
authorised products (NAPs) only
6.3.1. Biperiden – EMA/PSUR/0000317634
Applicants: various
PRAC Lead: Jan Neuhauser
Scope: Evaluation of a PSUSA procedure (PSUSA/00000415/202508)
Action: For adoption
6.3.2. Clonidine – EMA/PSUR/0000317638
Applicants: various
PRAC Lead: Carla Torre
Scope: Evaluation of a PSUSA procedure (PSUSA/00000813/202508)
Action: For adoption
6.3.3. Drospirenone / ethinylestradiol – EMA/PSUR/0000317652
Applicants: various
PRAC Lead: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00010217/202509)
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 35/50
6.3.4. Finasteride – EMA/PSUR/0000317641
Applicants: various
PRAC Lead: Mari Thorn
Scope: Evaluation of a PSUSA procedure (PSUSA/00001392/202508)
Action: For adoption
6.3.5. Fluocinolone acetonide (intravitreal implant in applicator) – EMA/PSUR/0000317680
Applicants: various
PRAC Lead: Carla Torre
Scope: Evaluation of a PSUSA procedure (PSUSA/00010224/202508)
Action: For adoption
6.3.6. Hexoprenaline sulfate – EMA/PSUR/0000317650
Applicants: various
PRAC Lead: Roxana Dondera
Scope: Evaluation of a PSUSA procedure (PSUSA/00003170/202508)
Action: For adoption
6.3.7. Losartan – EMA/PSUR/0000317642
Applicants: various
PRAC Lead: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00001912/202509)
Action: For adoption
6.3.8. Meclozine – EMA/PSUR/0000317667
Applicants: various
PRAC Lead: Jo Robays
Scope: Evaluation of a PSUSA procedure (PSUSA/00001945/202508)
Action: For adoption
6.3.9. Metronidazole / neomycin / nystatin – EMA/PSUR/0000317665
Applicants: various
PRAC Lead: Zoubida Amimour
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 36/50
Scope: Evaluation of a PSUSA procedure (PSUSA/00010508/202509)
Action: For adoption
6.3.10. Nifedipine – EMA/PSUR/0000317647
Applicants: various
PRAC Lead: Bianca Mulder
Scope: Evaluation of a PSUSA procedure (PSUSA/00002156/202508)
Action: For adoption
6.3.11. Poractant alfa – EMA/PSUR/0000317645
Applicants: various
PRAC Lead: Terhi Lehtinen
Scope: Evaluation of a PSUSA procedure (PSUSA/00002478/202508)
Action: For adoption
6.3.12. Povidone, polyvinyl alcohol / povidone – EMA/PSUR/0000317643
Applicants: various
PRAC Lead: Adam Przybylkowski
Scope: Evaluation of a PSUSA procedure (PSUSA/00002475/202509)
Action: For adoption
6.3.13. Raltitrexed – EMA/PSUR/0000317648
Applicants: various
PRAC Lead: Veronika Macurova
Scope: Evaluation of a PSUSA procedure (PSUSA/00002605/202509)
Action: For adoption
6.4. Follow-up to PSUR/PSUSA procedures
None
6.5. Variation procedure(s) resulting from PSUSA evaluation
6.5.1. Natalizumab – TYSABRI (CAP) – EMA/VR/0000315289
Applicant: Biogen Netherlands B.V.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 37/50
PRAC Rapporteur: Dirk Mentzer
Scope: Update of sections 4.2, 4.4 of the SmPC, and Annex II in order to align with the
revised content of the additional risk minimisation materials in the RMP following the PRAC
recommendation in EU PSUR 23 for the Tysabri (EMEA/H/C/PSUSA/00002127/202408). The
Package Leaflet is updated accordingly. The RMP version 34.1 has been submitted; the due
date for the provision of the final CSR for category 3 PASS study 101MS412 is also being
revised.
Action: For adoption
6.6. Expedited summary safety reviews5
None
7. Post-authorisation safety studies (PASS)
7.1. Protocols of PASS imposed in the marketing authorisation(s)6
7.1.1. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) –
EMA/PASS/0000328042
Applicant: Bristol-Myers Squibb Pharma EEIG
PRAC Rapporteur: Dirk Mentzer
Scope: PASS amendment [107o]: Non-interventional PASS of patients treated with
commercially available liso-cel (lisocabtagene maraleucel) for large B-cell lymphomas
Action: For adoption
7.1.2. Sodium valproate (NAP) – EMA/PASS/0000328174
Applicants: various
PRAC Rapporteur: Liana Martirosyan
Scope: PASS interim report: valproate [study protocol evaluated within procedure
EMEA/H/N/PSP/J/0094]; AVALON: Assessment of VALproate in utero exposure On
Neurodevelopment
Action: For adoption
5 Submission of expedited summary safety reports for review in addition to the requirements for submission of PSUR(s) falling
within the pandemic period and requirements set out in the list of Union reference dates (EURD list) provided for under Article
107c(7) of Directive 2001/83/EC
6 In accordance with Article 107n of Directive 2001/83/EC
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 38/50
7.2. Protocols of PASS non-imposed in the marketing authorisation(s)7
7.2.1. Chikungunya vaccine (recombinant, adsorbed) – VIMKUNYA (CAP) –
EMA/PAM/0000276447
Applicant: Bavarian Nordic A/S
PRAC Rapporteur: Liana Martirosyan
Scope: Submission of the protocol for the post-authorisation safety study BN-CV-317-011
(version 1.0) which is a category 3 study in the RMP. BN-CV-317-011 is an observational
prospective study to evaluate the safety of Vimkunya in pregnant women and their offspring.
Action: For adoption
7.2.2. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000325493
Applicant: Amgen Europe B.V.
PRAC Rapporteur: Amelia Cupelli
Scope: Protocol amendment submission of PASS Cat.3 Study A real-world observational
study of treatment patterns and outcomes for patients with neuromyelitis optica spectrum
disorders (NMOSDs) and immunoglobulin G4-related disease (IgG4-RD) treated with
inebilizumab (UPLIZNA) in Europe
Action: For adoption
7.2.3. Vamorolone – AGAMREE (CAP) – EMA/PAM/0000274869
Applicant: Santhera Pharmaceuticals (Deutschland) GmbH
PRAC Rapporteur: Rhea Fitzgerald
Scope: PASS protocol for a non-interventional, post-authorisation safety study to evaluate
the safety of vamorolone (AGAMREE®) in patients with Duchenne muscular dystrophy in a
real world setting.
Action: For adoption
7.3. Results of PASS imposed in the marketing authorisation(s)8
None
7 In accordance with Article 107m of Directive 2001/83/EC, supervised by PRAC in accordance with Article 61a (6) of
Regulation (EC) No 726/2004
8 In accordance with Article 107p-q of Directive 2001/83/EC
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 39/50
7.4. Results of PASS imposed and non-imposed in the marketing
authorisation(s)9
7.4.1. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000302705
Applicant: BioNTech Manufacturing GmbH
PRAC Rapporteur: Liana Martirosyan
Scope: Submission of the final report, protocol amendment #6 and SAP amendment #5 for
the non-interventional study C4591021, listed as a category 3 PASS in the RMP. This is a
post conditional approval active surveillance study among individuals in Europe receiving the
Pfizer BioNTech Coronavirus Disease 2019 (COVID-19) vaccine. The RMP version 15.1 has
also been submitted.
Action: For adoption
7.4.2. Elosulfase alfa – VIMIZIM (CAP) – EMA/VR/0000268096
Applicant: Biomarin International Limited
PRAC Rapporteur: Rhea Fitzgerald
Scope: Update of sections 4.6, 4.8 and 5.1 of the SmPC based on final results from Morquio
A Registry Study (MARS, Study 110-504) listed as a category 1 study in the RMP; this is an
observational registry study to evaluate long-term safety and effectiveness of elosulfase alfa.
The RMP version 7.0 has also been submitted. In addition, the MAH took the opportunity to
update Annex II and to update the PI in accordance with the latest EMA excipients guideline.
Action: For adoption
7.4.3. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000296039
Applicant: UCB Pharma
PRAC Rapporteur: Dennis Lex
Scope: Submission of the final report for study EP0220 listed as a category 3 study in the
RMP. This is a non-interventional study to assess the effectiveness of risk minimization
measures in approved indications for fenfluramine hydrochloride. The RMP version 5.1 has
been updated accordingly.
Action: For adoption
7.4.4. Linaclotide – CONSTELLA (CAP) – EMA/VR/0000281586
Applicant: Abbvie Deutschland GmbH & Co. KG
PRAC Rapporteur: Dennis Lex
9 In accordance with Article 61a (6) of Regulation (EC) No 726/2004, in line with the revised variations regulation for any
submission as of 4 August 2013
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 40/50
Scope: Submission of the final report from study EVM-18888 (P21-481) listed as a category
3 study in the RMP. The study, titled "Linaclotide Safety Study for the Assessment of
Diarrhoea Complications and Associated Risk Factors in Selected European Populations with
IBS-C," is an observational safety study. It assesses the risk of severe complications of
diarrhoea (SCD) during treatment with linaclotide, as well as other risk factors among
patients with IBS-C in the UK, Sweden, and Spain. The RMP version 11.2 has also been
submitted.
Action: For adoption
7.5. Interim results and other post-authorisation measures for imposed
and non-imposed studies
7.5.1. Clascoterone – WINLEVI (CAP) – EMA/PAM/0000325634
Applicant: Cassiopea S.p.A.
PRAC Rapporteur: Zane Neikena
Scope: Feasibility assessment for a post- authorisation safety study (PASS) to characterise
the potential risk of HPA axis suppression with long-term use of Winlevi in adolescents
Action: For adoption
7.5.2. Damoctocog alfa pegol – JIVI (CAP) – EMA/PAM/0000324421
Applicant: Bayer AG
PRAC Rapporteur: Bianca Mulder
Scope: 17th annual report for Study 14149: EUHASS Registry (European Haemophilia Safety
Surveillance)
Action: For adoption
7.5.3. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000323622
Applicant: UCB Pharma
PRAC Rapporteur: Dennis Lex
Scope: EP0241 Final Clinical Study Report for non-interventional retrospective cohort study
using national pharmacy database to evaluate the real-world use of fenfluramine (Fintepla)
for Dravet syndrome, Lennox-Gastaut syndrome, and other epilepsies in the United States.
Action: For adoption
7.5.4. Infliximab – REMSIMA (CAP) – EMA/PAM/0000325710
Applicant: Celltrion Healthcare Hungary Kft.
PRAC Rapporteur: Kimmo Jaakkola
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 41/50
Scope: 3rd annual recruitment report for Study CT-P13 4.8, an observational, prospective
cohort study to evaluate safety of Remsima SC (subcutaneous) in patients with Rheumatoid
Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis; former MEA 020
Action: For adoption
7.5.5. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) –
EMA/PAM/0000292603
Applicant: Orexigen Therapeutics Ireland Limited
PRAC Rapporteur: Dennis Lex
Scope: Study NB-451: Interim report of Drug Utilisation and Safety Study (Study NB-451)
for Mysimba/ Contrave in Europe and the United States.
Action: For adoption
7.5.6. Nirmatrelvir / Ritonavir – PAXLOVID (CAP) – EMA/PAM/0000324414
Applicant: Pfizer Europe MA EEIG
PRAC Rapporteur: Dennis Lex
Scope: The second interim report (31 December 2025) for PASS C4671047: Use and safety
of Paxlovid among patients with moderate or severe hepatic impairment.
Action: For adoption
7.5.7. Nonacog beta pegol – REFIXIA (CAP) – EMA/PAM/0000323326
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Dirk Mentzer
Scope: 7th progress report of study NN7999-4031: A non-interventional post-authorisation
safety study (PASS) in male haemophilia B patients receiving Nonacog Beta Pegol (N9-GP)
prophylaxis treatment.
Action: For adoption
7.5.8. Rivaroxaban – XARELTO (CAP) – EMA/PAM/0000316572
Applicant: Bayer AG
PRAC Rapporteur: Mari Thorn
Scope: Third study progress report for the Paediatric VTE PASS Drug Utilization Study
(XAPAEDUS): An observational, longitudinal, multi-source drug utilization safety study to
evaluate the drug use patterns and safety of rivaroxaban oral suspension in children under
two years with venous thromboembolism.
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
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7.5.9. Sebelipase alfa – KANUMA (CAP) – EMA/PAM/0000320327
Applicant: Alexion Europe
PRAC Rapporteur: Mari Thorn
Scope: LAL-D registry 8th interim report of Study ALX-LALD-501, An observational disease
and clinical outcomes registry of patients with lysosomal acid lipase (lal) deficiency dated 02
December 2025 (cut-off date: 28 August 2025)
Action: For adoption
7.5.10. Selexipag – UPTRAVI (CAP) – EMA/PAM/0000309454
Applicant: Janssen Cilag International
PRAC Rapporteur: Zoubida Amimour
Scope: Second interim Clinical study report of study AC-065A403 (EDUCATE), a category 3
PASS study (EMEA/H/C/003774/MEA/003) with a data cut-off date of 11 July 2025.
Action: For adoption
7.5.11. Vosoritide – VOXZOGO (CAP) – EMA/PAM/0000321452
Applicant: Biomarin International Limited
PRAC Rapporteur: Zane Neikena
Scope: Provision of 2nd Bi-annual safety report for PASS study 111-603 (former MEA 005.6).
Action: For adoption
7.5.12. Zanubrutinib – BRUKINSA (CAP) – EMA/PAM/0000319828
Applicant: Beone Medicines Ireland Limited
PRAC Rapporteur: Bianca Mulder
Scope: Interim report of study BGB-3111-LTE1: an open-label, multicenter, long-term
extension study of zanubrutinib (BGB-3111) regimens in patients with B-cell malignancies
Action: For adoption
8. Renewals of the marketing authorisation, conditional renewal
and annual reassessments
8.1. Annual reassessments of the marketing authorisation
8.1.1. Afamelanotide – SCENESSE (CAP) – EMA/S/0000322534
Applicant: Clinuvel Europe Limited
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 43/50
PRAC Rapporteur: Dennis Lex
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.2. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329
Applicant: Serb
PRAC Rapporteur: Dennis Lex
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.3. Histamine dihydrochloride – CEPLENE (CAP) – EMA/S/0000319752
Applicant: Laboratoires Delbert
PRAC Rapporteur: Eamon O Murchu
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.4. Maralixibat – LIVMARLI (CAP) – EMA/S/0000317715
Applicant: Mirum Pharmaceuticals International B.V.
PRAC Rapporteur: Adam Przybylkowski
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.5. Tagraxofusp – ELZONRIS (CAP) – EMA/S/0000320819
Applicant: Stemline Therapeutics B.V.
PRAC Rapporteur: Bianca Mulder
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
8.1.6. Vilobelimab – GOHIBIC (CAP) – EMA/S/0000319310
Applicant: InflaRx GmbH
PRAC Rapporteur: Liana Martirosyan
Scope: Annual reassessment of the marketing authorisation
Action: For adoption
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 44/50
8.2. Conditional renewals of the marketing authorisation
8.2.1. Imlifidase – IDEFIRIX (CAP) – EMA/R/0000327647
Applicant: Hansa Biopharma AB
PRAC Rapporteur: Bianca Mulder
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.2. Resmetirom – REZDIFFRA (CAP) – EMA/R/0000326759
Applicant: Madrigal Pharmaceuticals EU Limited
PRAC Rapporteur: Lina Seibokiene
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.3. Talquetamab – TALVEY (CAP) – EMA/R/0000327092
Applicant: Janssen Cilag International
PRAC Rapporteur: Barbara Kovacic Bytyqi
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.2.4. Teclistamab – TECVAYLI (CAP) – EMA/R/0000327677
Applicant: Janssen Cilag International
PRAC Rapporteur: Veronika Macurova
Scope: Conditional renewal of the marketing authorisation
Action: For adoption
8.3. Renewals of the marketing authorisation
None
9. Product related pharmacovigilance inspections
9.1. List of planned pharmacovigilance inspections
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 45/50
9.2. Ongoing or concluded pharmacovigilance inspections
Disclosure of information on results of pharmacovigilance inspections could undermine the
protection of the purpose of these inspections, investigations and audits. Therefore such
information is not reported in the agenda.
9.3. Others
None
10. Other safety issues for discussion requested by the Member
States, CHMP or the EMA
10.1.1. Αnti-t lymphocyte immunoglobulin for human use, rabbit (NAP) – ES
2026/62650/II/0122, DE II-2601996-20251223-01, IE/H/xxxx/WS/395,
SE/H/xxxx/WS/1162, FR/H/xxxx/WS/627, DK/H/xxxx/WS/495
Applicant(s): Sanofi B.V.
PRAC Lead: Maria Martinez Gonzalez
Scope: PRAC consultation on variation procedures (ES 2026/62650/II/0122 and DE II-
2601996-20251223-01) and worksharing variations (IE/H/xxxx/WS/395,
SE/H/xxxx/WS/1162, FR/H/xxxx/WS/627, DK/H/xxxx/WS/495) to update the product
information of anti-t lymphocyte immunoglobulin for human use, rabbit-containing
medicinal products, regarding thrombotic microangiopathy (TMA), at request of Spain.
Action: For adoption
11. Scientific advice procedures
Information related to this section cannot be released at the present time as it is deemed to
contain commercially confidential information.
12. Organisational, regulatory and methodological matters
12.1. Mandate and organisation of the PRAC
12.1.1. PRAC membership
Action: For information
12.1.2. Nominated proxy
Action: For information
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 46/50
12.2. Coordination with EMA Scientific Committees or CMDh-v
None
12.3. Coordination with EMA Working Parties/Working Groups/Drafting
Groups
None
12.4. Cooperation within the EU regulatory network
12.4.1. Health threats and EMA Emergency Task Force (ETF) activities - update
Action: For discussion
12.4.2. PRAC strategic review and learning meeting (SRLM) under the Cyprus presidency of
the European Union (EU) Council – Pafos, Cyprus, 12 – 13 May 2026 - agenda
PRAC lead: Panagiotis Psaras
Action: For discussion
12.5. Cooperation with International Regulators
None
12.6. Contacts of the PRAC with external parties and interaction with the
Interested Parties to the Committee
None
12.7. PRAC work plan
None
12.8. Planning and reporting
None
12.9. Pharmacovigilance audits and inspections
12.9.1. Pharmacovigilance systems and their quality systems
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 47/50
12.9.2. Pharmacovigilance inspections
None
12.9.3. Pharmacovigilance audits
None
12.10. Periodic safety update reports (PSURs) & Union reference date
(EURD) list
12.10.1. Periodic safety update reports
None
12.10.2. PSURs repository
None
12.10.3. Union reference date list – consultation on the draft list
Action: For adoption
12.11. Signal management
None
12.12. Adverse drug reactions reporting and additional reporting
12.12.1. Management and reporting of adverse reactions to medicinal products
None
12.12.2. Additional monitoring
None
12.12.3. List of products under additional monitoring – consultation on the draft list
Action: For adoption
12.12.4. Good Pharmacovigilance Practice (GVP) module VI on Management and reporting of
adverse reactions to medicinal products - revision
PRAC lead : Dennis Lex
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 48/50
Action: For information
12.13. EudraVigilance database
12.13.1. Activities related to the confirmation of full functionality
None
12.14. Risk management plans and effectiveness of risk minimisations
12.14.1. Risk management systems
None
12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations
None
12.15. Post-authorisation safety studies (PASS)
12.15.1. Post-authorisation Safety Studies – imposed PASS
None
12.15.2. Post-authorisation Safety Studies – non-imposed PASS
None
12.16. Community procedures
12.16.1. Referral procedures for safety reasons
None
12.17. Renewals, conditional renewals, annual reassessments
None
12.18. Risk communication and transparency
12.18.1. Public participation in pharmacovigilance
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 49/50
12.18.2. Safety communication
None
12.19. Continuous pharmacovigilance
12.19.1. Incident management
None
12.20. Impact of pharmacovigilance activities
12.20.1. Strategy on measuring the impact of pharmacovigilance – PRAC interest group (IG)
Impact - Annual activity report 2025
PRAC Lead: Liana Martirosyan
Action: For adoption
12.21. Others
12.21.1. Guideline on risk assessment of medicinal products on human reproduction and
lactation: from data to labelling
PRAC lead: Ulla Wändel Liminga
Action: For discussion
13. Any other business
None
14. Explanatory notes
The Notes give a brief explanation of relevant agenda items and should be read in conjunction with the
agenda.
List of acronyms and abbreviations
For a list of acronyms and abbreviations used in the PRAC agenda, see:
List of abbreviations used in EMA human medicines scientific committees and CMDh documents, and in
relation to EMA’s regulatory activities
EU Referral procedures for safety reasons: Urgent EU procedures and Other EU referral
procedures
(Items 2 and 3 of the PRAC agenda)
A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a
medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a
particular medicine or class of medicines on behalf of the European Union (EU). For further detailed
information on safety related referrals please see: Referral procedures: human medicines | European
Medicines Agency (europa.eu)
https://www.ema.europa.eu/en/documents/other/abbreviations-used-ema-scientific-committees-and-cmd-documents-and-relation-emas-regulatory-activities_en.pdf
https://www.ema.europa.eu/en/documents/other/abbreviations-used-ema-scientific-committees-and-cmd-documents-and-relation-emas-regulatory-activities_en.pdf
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/68437/2026 Page 50/50
Signals assessment and prioritisation
(Item 4 of the PRAC agenda)
A safety signal is information on a new or incompletely documented adverse event that is potentially caused
by a medicine and that warrants further investigation. Signals are generated from several sources such as
spontaneous reports, clinical studies and the scientific literature. The evaluation of safety signals is a routine
part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive
knowledge of a medicine’s benefits and risks.
The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The
adverse event could be a symptom of another illness or caused by another medicine taken by the patient.
The evaluation of safety signals is required to establish whether or not there is a causal relationship between
the medicine and the reported adverse event.
The evaluation of safety signals may not necessarily conclude that the medicine caused the adverse event in
question. In cases where a causal relationship is confirmed or considered likely, regulatory action may be
necessary and this usually takes the form of an update of the summary of product characteristics and the
package leaflet.
Risk Management Plans (RMPs)
(Item 5 of the PRAC agenda)
The RMP describes what is known and not known about the side effects of a medicine and states how these
risks will be prevented or minimised in patients. It also includes plans for studies and other activities to gain
more knowledge about the safety of the medicine and risk factors for developing side effects.
RMPs are continually modified and updated throughout the lifetime of the medicine as new information
becomes available.
Assessment of Periodic Safety Update Reports (PSURs)
(Item 6 of the PRAC agenda)
A PSUR is a report providing an evaluation of the benefit-risk balance of a medicine, which is submitted by
marketing authorisation holders at defined time points following a medicine’s authorisation.
PSURs summarises data on the benefits and risks of a medicine and includes the results of all studies carried
out with this medicine (in the authorised and unauthorised indications).
Post-authorisation Safety Studies (PASS)
(Item 7 of the PRAC agenda)
A PASS is a study of an authorised medicinal product carried out to obtain further information on its safety,
or to measure the effectiveness of risk management measures. The results of a PASS help regulatory
agencies to evaluate the safety and benefit-risk profile of a medicine.
Product related pharmacovigilance inspections
(Item 9 of the PRAC agenda)
Inspections carried out by regulatory agencies to ensure that marketing authorisation holders comply with
their pharmacovigilance obligations.
More detailed information on the above terms can be found on the EMA website: www.ema.europa.eu/
Article 58 procedures (Art 58)
Article 58 of Regulation (EC) No 726/2004 allows the Committee for Medicinal Products for Human Use
(CHMP) to give opinions, in co-operation with the World Health Organisation (WHO) on medicinal products
for human use that are intended exclusively for markets outside of the European Union (EU)
http://www.ema.europa.eu/
1. Introduction
1.1. Welcome and declarations of interest of members, alternates and experts
1.2. Agenda of the meeting on 07-10 April 2026
1.3. Minutes of the previous meeting on 09-12 March 2026
2. EU referral procedures for safety reasons: urgent EU procedures
2.1. Newly triggered procedures
2.2. Ongoing procedures
2.3. Procedures for finalisation
3. EU referral procedures for safety reasons: other EU referral procedures
3.1. Newly triggered procedure
3.2. Ongoing procedures
3.3. Procedures for finalisation
3.4. Re-examination procedures
3.5. Others
4. Signals assessment and prioritisation
4.1. New signals detected from EU spontaneous reporting systems and/or other sources
4.1.1. Binimetinib - MEKTOVI (CAP); Encorafenib – BRAFTOVI (CAP)
4.2. Signals follow-up and prioritisation
4.2.1. Axicabtagene ciloleucel – YESCARTA (CAP) - EMEA/H/C/002695/SDA/019; lisocabtagene maraleucel – Breyanzi (CAP) - EMEA/H/C/002695/SDA/025
4.2.2. Ponatinib - ICLUSIG (CAP) - EMEA/H/C/002695/SDA/019
4.2.3. Tirzepatide - MOUNJARO (CAP); MOUNJARO KWIKPEN (CAP) - EMEA/H/C/005620/SDA/007
4.3. Variation procedure(s) resulting from signal evaluation
5. Risk management plans (RMPs)
5.1. Medicines in the pre-authorisation phase
5.1.1. Catequentinib (CAP MAA) - EMEA/H/C/006317, Orphan
5.1.2. Denosumab (CAP MAA) - EMEA/H/C/006626
5.1.3. Ensitrelvir (CAP MAA) - EMEA/H/C/006063
5.1.4. Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated (CAP MAA) - EMEA/H/C/006692
5.1.5. Insulin efsitora alfa (CAP MAA) - EMEA/H/C/006388
5.1.6. Leriglitazone (CAP MAA) - EMEA/H/C/006693, Orphan
5.1.7. Levodopa / Carbidopa (CAP MAA) - EMEA/H/C/006629
5.1.8. Narsoplimab (CAP MAA) - EMEA/H/C/005247, Orphan
5.1.9. Norucholic acid (CAP MAA) - EMEA/H/C/006515, Orphan
5.2. Medicines in the post-authorisation phase – PRAC-led procedures
5.2.1. Bosentan – STAYVEER (CAP); TRACLEER (CAP) – EMA/VR/0000316336
5.2.2. Carfilzomib – KYPROLIS (CAP) – EMA/VR/0000325402
5.2.3. Ocrelizumab – OCREVUS (CAP) – EMA/VR/0000291534
5.3. Medicines in the post-authorisation phase – CHMP-led procedures
5.3.1. Afamelanotide – SCENESSE (CAP) – EMA/VR/0000325360
5.3.2. Alpelisib – PIQRAY (CAP) – EMA/VR/0000317159
5.3.3. Atogepant – AQUIPTA (CAP) – EMA/VR/0000310717
5.3.4. Axicabtagene ciloleucel – YESCARTA (CAP); Brexucabtagene autoleucel – TECARTUS (CAP) – EMA/VR/0000308229
5.3.5. Berotralstat – ORLADEYO (CAP) – EMA/X/0000268892
5.3.6. Capivasertib – TRUQAP (CAP) – EMA/VR/0000293735
5.3.7. Ceftolozane / Tazobactam – ZERBAXA (CAP) – EMA/VR/0000320716
5.3.8. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000320534
5.3.9. Dapivirine – DAPIVIRINE VAGINAL RING 25 MG (CAP) – EMA/X/0000314697
5.3.10. Decitabine / Cedazuridine – INAQOVI (CAP) – EMA/VR/0000304730
5.3.11. Deucravacitinib – SOTYKTU (CAP) – EMA/VR/0000309456
5.3.12. Evolocumab – REPATHA (CAP) – EMA/VR/0000322435
5.3.13. Fedratinib – INREBIC (CAP) – EMA/VR/0000324950
5.3.14. Human normal immunoglobulin – PRIVIGEN (CAP) – EMA/VR/0000304719
5.3.15. Influenza vaccine (live, nasal) – FLUENZ (CAP) – EMA/VR/0000302352
5.3.16. Insulin icodec / Semaglutide – KYINSU (CAP) – EMA/VR/0000322527
5.3.17. Lisocabtagene maraleucel / Lisocabtagene maraleucel – Breyanzi (CAP) – EMA/VR/0000327431
5.3.18. Mavacamten – CAMZYOS (CAP) – EMA/VR/0000294573
5.3.19. Naloxone – NYXOID (CAP) – EMA/VR/0000325329
5.3.20. Nivolumab – OPDIVO (CAP) – EMA/VR/0000304938
5.3.21. Pandemic influenza vaccine (H5N1) (live attenuated, nasal) – PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA (CAP) – EMA/VR/0000321324
5.3.22. Risankizumab – SKYRIZI (CAP) – EMA/X/0000296763
5.3.23. Sacituzumab govitecan – TRODELVY (CAP) – EMA/VR/0000320818
5.3.24. Semaglutide – WEGOVY (CAP) – EMA/X/0000296344
5.3.25. Semaglutide – WEGOVY (CAP) – EMA/VR/0000327359
5.3.26. Teclistamab – TECVAYLI (CAP) – EMA/VR/0000322279
5.3.27. Tedizolid phosphate – SIVEXTRO (CAP) – EMA/X/0000282136
5.3.28. Tezepelumab – TEZSPIRE (CAP) – EMA/VR/0000321455
5.3.29. Tolvaptan – JINARC (CAP) – EMA/VR/0000246866
5.3.30. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000322236
5.3.31. Trastuzumab deruxtecan – ENHERTU (CAP) – EMA/VR/0000293327
5.3.32. Vamorolone – AGAMREE (CAP) – EMA/VR/0000293535
5.3.33. Venetoclax – VENCLYXTO (CAP) – EMA/VR/0000322237
5.3.34. Venetoclax – VENCLYXTO (CAP) – EMA/VR/0000322240
6. Periodic safety update reports (PSURs)
6.1. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) only
6.1.1. Abrocitinib – CIBINQO (CAP) – EMA/PSUR/0000317674
6.1.2. Aprocitentan – JERAYGO (CAP) – EMA/PSUR/0000317689
6.1.3. Asenapine – SYCREST (CAP) – EMA/PSUR/0000317636
6.1.4. Bedaquiline – SIRTURO (CAP) – EMA/PSUR/0000317651
6.1.5. Brentuximab vedotin – ADCETRIS (CAP) – EMA/PSUR/0000317688
6.1.6. Caplacizumab – CABLIVI (CAP) – EMA/PSUR/0000317662
6.1.7. Cenobamate – ONTOZRY (CAP) – EMA/PSUR/0000317671
6.1.8. Crizotinib – XALKORI (CAP) – EMA/PSUR/0000317663
6.1.9. Damoctocog alfa pegol – JIVI (CAP) – EMA/PSUR/0000317669
6.1.10. Dasiglucagon – ZEGALOGUE (SRD ) – EMA/PSUR/0000317683
6.1.11. Deucravacitinib – SOTYKTU (CAP) – EMA/PSUR/0000317694
6.1.12. Doravirine – PIFELTRO (CAP) – EMA/PSUR/0000317664
6.1.13. Doravirine / Lamivudine / Tenofovir disoproxil – DELSTRIGO (CAP) – EMA/PSUR/0000317666
6.1.14. Duvelisib – COPIKTRA (SRD ) – EMA/PSUR/0000317672
6.1.15. Ebola vaccine (Ad26.ZEBOV-GP [recombinant]) – ZABDENO (CAP); Ebola vaccine (MVA-BN-Filo [recombinant]) – MVABEA (CAP) – EMA/PSUR/0000317690
6.1.16. Epcoritamab – TEPKINLY (CAP) – EMA/PSUR/0000317637
6.1.17. Filgotinib – JYSELECA (CAP) – EMA/PSUR/0000317681
6.1.18. Fruquintinib – FRUZAQLA (CAP) – EMA/PSUR/0000317678
6.1.19. Ganaxolone – ZTALMY (CAP) – EMA/PSUR/0000317639
6.1.20. Infliximab – FLIXABI (CAP); INFLECTRA (CAP); REMICADE (CAP); REMSIMA (CAP); ZESSLY (CAP) – EMA/PSUR/0000317670
6.1.21. Insulin icodec – AWIQLI (CAP) – EMA/PSUR/0000317726
6.1.22. Lebrikizumab – EBGLYSS (CAP) – EMA/PSUR/0000317693
6.1.23. Linaclotide – CONSTELLA (CAP) – EMA/PSUR/0000317653
6.1.24. Lorlatinib – LORVIQUA (CAP) – EMA/PSUR/0000317668
6.1.25. Influenza vaccine (live, nasal) – FLUENZ (CAP) – EMA/PSUR/0000317656
6.1.26. Mecasermin – INCRELEX (CAP) – EMA/PSUR/0000317644
6.1.27. Mepolizumab – NUCALA (CAP) – EMA/PSUR/0000317655
6.1.28. Momelotinib – OMJJARA (CAP) – EMA/PSUR/0000317675
6.1.29. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) – EMA/PSUR/0000317654
6.1.30. Ofatumumab – KESIMPTA (CAP) – EMA/PSUR/0000317682
6.1.31. Retifanlimab – ZYNYZ (CAP) – EMA/PSUR/0000317673
6.1.32. Rezafungin – REZZAYO (CAP) – EMA/PSUR/0000317633
6.1.33. Ritonavir – NORVIR (CAP) – EMA/PSUR/0000317692
6.1.34. Ruxolitinib – OPZELURA (CAP) – EMA/PSUR/0000317686
6.1.35. Serplulimab – HETRONIFLY (CAP) – EMA/PSUR/0000317684
6.1.36. Sotatercept – WINREVAIR (CAP) – EMA/PSUR/0000317685
6.1.37. Spesolimab – SPEVIGO (CAP) – EMA/PSUR/0000317676
6.1.38. Tasonermin – BEROMUN (CAP) – EMA/PSUR/0000317660
6.1.39. Tenecteplase – METALYSE (CAP) – EMA/PSUR/0000317658
6.1.40. Tisotumab vedotin – TIVDAK (CAP) – EMA/PSUR/0000317687
6.1.41. Vemurafenib – ZELBORAF (CAP) – EMA/PSUR/0000317646
6.1.42. Vernakalant – BRINAVESS (CAP) – EMA/PSUR/0000317649
6.1.43. Vibegron – OBGEMSA (CAP) – EMA/PSUR/0000317679
6.1.44. Zilucoplan – ZILBRYSQ (CAP) – EMA/PSUR/0000317635
6.2. PSUR single assessment (PSUSA) procedures including centrally authorised products (CAPs) and nationally authorised products (NAPs)
6.2.1. Atropine sulfate – RYJUNEA (CAP); NAP – EMA/PSUR/0000317677
6.2.2. Budesonide / Formoterol – BIRESP SPIROMAX (CAP); DUORESP SPIROMAX (CAP); Budesonide / Formoterol fumarate dihydrate – GORESP DIGIHALER (CAP); NAP – EMA/PSUR/0000317659
6.2.3. Octocog alfa – ADVATE (CAP); KOVALTRY (CAP); NAP – EMA/PSUR/0000317640
6.2.4. Trientine – CUFENCE (CAP); CUPRIOR (CAP); NAP – EMA/PSUR/0000317661
6.3. PSUR single assessment (PSUSA) procedures including nationally authorised products (NAPs) only
6.3.1. Biperiden – EMA/PSUR/0000317634
6.3.2. Clonidine – EMA/PSUR/0000317638
6.3.3. Drospirenone / ethinylestradiol – EMA/PSUR/0000317652
6.3.4. Finasteride – EMA/PSUR/0000317641
6.3.5. Fluocinolone acetonide (intravitreal implant in applicator) – EMA/PSUR/0000317680
6.3.6. Hexoprenaline sulfate – EMA/PSUR/0000317650
6.3.7. Losartan – EMA/PSUR/0000317642
6.3.8. Meclozine – EMA/PSUR/0000317667
6.3.9. Metronidazole / neomycin / nystatin – EMA/PSUR/0000317665
6.3.10. Nifedipine – EMA/PSUR/0000317647
6.3.11. Poractant alfa – EMA/PSUR/0000317645
6.3.12. Povidone, polyvinyl alcohol / povidone – EMA/PSUR/0000317643
6.3.13. Raltitrexed – EMA/PSUR/0000317648
6.4. Follow-up to PSUR/PSUSA procedures
6.5. Variation procedure(s) resulting from PSUSA evaluation
6.5.1. Natalizumab – TYSABRI (CAP) – EMA/VR/0000315289
6.6. Expedited summary safety reviews
7. Post-authorisation safety studies (PASS)
7.1. Protocols of PASS imposed in the marketing authorisation(s)
7.1.1. Lisocabtagene maraleucel / Lisocabtagene maraleucel – BREYANZI (CAP) – EMA/PASS/0000328042
7.1.2. Sodium valproate (NAP) – EMA/PASS/0000328174
7.2. Protocols of PASS non-imposed in the marketing authorisation(s)
7.2.1. Chikungunya vaccine (recombinant, adsorbed) – VIMKUNYA (CAP) – EMA/PAM/0000276447
7.2.2. Inebilizumab – UPLIZNA (CAP) – EMA/PAM/0000325493
7.2.3. Vamorolone – AGAMREE (CAP) – EMA/PAM/0000274869
7.3. Results of PASS imposed in the marketing authorisation(s)
7.4. Results of PASS imposed and non-imposed in the marketing authorisation(s)
7.4.1. COVID-19 mRNA vaccine – COMIRNATY (CAP) – EMA/VR/0000302705
7.4.2. Elosulfase alfa – VIMIZIM (CAP) – EMA/VR/0000268096
7.4.3. Fenfluramine – FINTEPLA (CAP) – EMA/VR/0000296039
7.4.4. Linaclotide – CONSTELLA (CAP) – EMA/VR/0000281586
7.5. Interim results and other post-authorisation measures for imposed and non-imposed studies
7.5.1. Clascoterone – WINLEVI (CAP) – EMA/PAM/0000325634
7.5.2. Damoctocog alfa pegol – JIVI (CAP) – EMA/PAM/0000324421
7.5.3. Fenfluramine – FINTEPLA (CAP) – EMA/PAM/0000323622
7.5.4. Infliximab – REMSIMA (CAP) – EMA/PAM/0000325710
7.5.5. Naltrexone hydrochloride / Bupropion hydrochloride – MYSIMBA (CAP) – EMA/PAM/0000292603
7.5.6. Nirmatrelvir / Ritonavir – PAXLOVID (CAP) – EMA/PAM/0000324414
7.5.7. Nonacog beta pegol – REFIXIA (CAP) – EMA/PAM/0000323326
7.5.8. Rivaroxaban – XARELTO (CAP) – EMA/PAM/0000316572
7.5.9. Sebelipase alfa – KANUMA (CAP) – EMA/PAM/0000320327
7.5.10. Selexipag – UPTRAVI (CAP) – EMA/PAM/0000309454
7.5.11. Vosoritide – VOXZOGO (CAP) – EMA/PAM/0000321452
7.5.12. Zanubrutinib – BRUKINSA (CAP) – EMA/PAM/0000319828
8. Renewals of the marketing authorisation, conditional renewal and annual reassessments
8.1. Annual reassessments of the marketing authorisation
8.1.1. Afamelanotide – SCENESSE (CAP) – EMA/S/0000322534
8.1.2. Glucarpidase – VORAXAZE (CAP) – EMA/S/0000322329
8.1.3. Histamine dihydrochloride – CEPLENE (CAP) – EMA/S/0000319752
8.1.4. Maralixibat – LIVMARLI (CAP) – EMA/S/0000317715
8.1.5. Tagraxofusp – ELZONRIS (CAP) – EMA/S/0000320819
8.1.6. Vilobelimab – GOHIBIC (CAP) – EMA/S/0000319310
8.2. Conditional renewals of the marketing authorisation
8.2.1. Imlifidase – IDEFIRIX (CAP) – EMA/R/0000327647
8.2.2. Resmetirom – REZDIFFRA (CAP) – EMA/R/0000326759
8.2.3. Talquetamab – TALVEY (CAP) – EMA/R/0000327092
8.2.4. Teclistamab – TECVAYLI (CAP) – EMA/R/0000327677
8.3. Renewals of the marketing authorisation
9. Product related pharmacovigilance inspections
9.1. List of planned pharmacovigilance inspections
9.2. Ongoing or concluded pharmacovigilance inspections
9.3. Others
10. Other safety issues for discussion requested by the Member States, CHMP or the EMA
10.1.1. Αnti-t lymphocyte immunoglobulin for human use, rabbit (NAP) – ES 2026/62650/II/0122, DE II-2601996-20251223-01, IE/H/xxxx/WS/395, SE/H/xxxx/WS/1162, FR/H/xxxx/WS/627, DK/H/xxxx/WS/495
11. Scientific advice procedures
12. Organisational, regulatory and methodological matters
12.1. Mandate and organisation of the PRAC
12.1.1. PRAC membership
12.1.2. Nominated proxy
12.2. Coordination with EMA Scientific Committees or CMDh-v
12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups
12.4. Cooperation within the EU regulatory network
12.4.1. Health threats and EMA Emergency Task Force (ETF) activities - update
12.4.2. PRAC strategic review and learning meeting (SRLM) under the Cyprus presidency of the European Union (EU) Council – Pafos, Cyprus, 12 – 13 May 2026 - agenda
12.5. Cooperation with International Regulators
12.6. Contacts of the PRAC with external parties and interaction with the Interested Parties to the Committee
12.7. PRAC work plan
12.8. Planning and reporting
12.9. Pharmacovigilance audits and inspections
12.9.1. Pharmacovigilance systems and their quality systems
12.9.2. Pharmacovigilance inspections
12.9.3. Pharmacovigilance audits
12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list
12.10.1. Periodic safety update reports
12.10.2. PSURs repository
12.10.3. Union reference date list – consultation on the draft list
12.11. Signal management
12.12. Adverse drug reactions reporting and additional reporting
12.12.1. Management and reporting of adverse reactions to medicinal products
12.12.2. Additional monitoring
12.12.3. List of products under additional monitoring – consultation on the draft list
12.12.4. Good Pharmacovigilance Practice (GVP) module VI on Management and reporting of adverse reactions to medicinal products - revision
12.13. EudraVigilance database
12.13.1. Activities related to the confirmation of full functionality
12.14. Risk management plans and effectiveness of risk minimisations
12.14.1. Risk management systems
12.14.2. Tools, educational materials and effectiveness measurement of risk minimisations
12.15. Post-authorisation safety studies (PASS)
12.15.1. Post-authorisation Safety Studies – imposed PASS
12.15.2. Post-authorisation Safety Studies – non-imposed PASS
12.16. Community procedures
12.16.1. Referral procedures for safety reasons
12.17. Renewals, conditional renewals, annual reassessments
12.18. Risk communication and transparency
12.18.1. Public participation in pharmacovigilance
12.18.2. Safety communication
12.19. Continuous pharmacovigilance
12.19.1. Incident management
12.20. Impact of pharmacovigilance activities
12.20.1. Strategy on measuring the impact of pharmacovigilance – PRAC interest group (IG) Impact - Annual activity report 2025
12.21. Others
12.21.1. Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling
13. Any other business
14. Explanatory notes
08.04.2026
Datei
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AESGP
Issue 380 | January 2026
Euro OTC News
Table of Contents
MEDICINES _______________________________________________________________________________ 3
Regulatory News _____________________________________________________________________________________________ 3
• EMA Management Board - DEC 2025 - Meeting highlight _______________________________________________________ 3
• EMA Consolidated 3-year rolling work plan for the Non-clinical domain 2026-2028 ____________________________________ 4
• EMA consultation on ICH E22 Guideline on general considerations for patient preference studies ________________________ 4
• Multistakeholder workshop on Patient Registries for Alzheimer’s Disease on 15 DEC 2025 - Summary and recording of the event
____________________________________________________________________________________________________ 5
• CMDh Meeting Report - 9-11 DEC 2025 _____________________________________________________________________ 5
• Shortages - Union list of critical medicines v2.1 – Publication ____________________________________________________ 8
• Shortages - Publication of shortages reporting obligations factsheets and updated ESMP Q&A document __________________ 8
• Shortages - Publication of the SPP and SMP pilot report by the EMA ______________________________________________ 9
• EMA-FDA joint guiding principles for good AI practice in the medicines lifecycle ______________________________________ 9
Herbal medicines ___________________________________________________________________________________________ 10
• EMA HMPC Meeting Report - 17-19 NOV 2025 ______________________________________________________________ 10
FOOD __________________________________________________________________________________ 12
Risk Assessment ___________________________________________________________________________________________ 12
• EFSA Scientific opinion on the tolerable upper intake level for supplemental docosahexaenoic acid (DHA) ________________ 12
MEDICAL DEVICES _______________________________________________________________________ 13
MDR/IVDR Implementation ____________________________________________________________________________________ 13
• Overview on Applications for Designation as a NB - Update 02 December 2025 _____________________________________ 13
• Simplification Proposal - Publication of EC Legislative Proposal _________________________________________________ 13
• 52th NB Designated under MDR __________________________________________________________________________ 14
• Simplification Proposal - Feedback procedure opened _________________________________________________________ 14
• Study on Governance & Innovation - Publication of Final Report _________________________________________________ 14
• EMA's COMBO Meeting Report - 7 NOV 2025 _______________________________________________________________ 14
• EMA's Combination Products Operational Group - Publication of ToRs ____________________________________________ 15
• Publication of MDR-IVDR consolidated versions with proposed amendments integrated _______________________________ 16
Guidance on Breakthtrough Devices (BtX) ______________________________________________________________________ 16
• Regulations 2017/745 & 2017/746 ________________________________________________________________________ 16
TEAM NB Position Paper on SARS-CoV-2 _______________________________________________________________________ 16
• Test down-classification V1 ______________________________________________________________________________ 16
Annex VII __________________________________________________________________________________________________ 16
• Commission implementing regulation draft - TEAM NB position paper _____________________________________________ 16
European UDI WG ___________________________________________________________________________________________ 17
• MDCG 2025-7 Rev. 1 - Position Paper: Timelines of implementation of ‘Master UDI-DI’ to CL, SF and RTW reading spectacles
published ____________________________________________________________________________________________ 17
MDCG 2025–10 _____________________________________________________________________________________________ 17
• Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices published _______________ 17
Health Technology Assessment _______________________________________________________________________________ 18
• New Opportunity to Apply for Joint Scientific Consultations _____________________________________________________ 18
• MDCG Eudamed WG - Survey on Onboarding Materials for completion by Mid FEB _________________________________ 19
ENVIRONMENT __________________________________________________________________________ 20
Reflection paper on product environmental scoring - Member feedback requested - 5 FEB 2026 __________________________ 20
Microplastics reporting under Commission Regulation 2023/2055 - Draft amendment to Annex XVII, entry 78 _______________ 20
AESGP OTC News | September 2025 2 | 23
CROSS-SECTORIAL NEWS _________________________________________________________________ 21
General Pharmaceutical Legislation Revision - EP and Council reach trilogue agreement _______________________________ 21
Biotech Act - European Commission publishes a legislative proposal ________________________________________________ 21
AESGP OTC News | January 2026
3 | 23
Regulatory News
EMA Management Board - DEC 2025 - Meeting
highlight
The highlights of the EMA Management Board December 2025 meeting have been published. Among
the items reported, the following may be noted:
The Management Board opened its meeting welcoming the political agreement reached by the European
Commission, the European Parliament and the Council of the European Union on the new EU
pharmaceutical legislation.
The Board adopted EMA’s work programme for 2026, which sets out the Agency’s priorities for the coming
year. While EMA will continue to ensure the highest standards in the evaluation and supervision of human
and veterinary medicines, work during 2026 will focus on intense preparation for the changes
introduced by the new EU pharmaceutical legislation, supporting innovation for public and animal
health and investing in developing our staff across the European medicines regulatory network. As EMA
carries out its work across these three areas, it will seize opportunities to modernise the regulatory system
in response to rapid scientific and technological advances, enhancing efficiency through digitalisation and
artificial intelligence, while expanding early development support to enable new medicines to be
authorised in the EU as rapidly as possible.
The Board adopted the final programming document for 2026-2028 (to be published at the end of January
2026) and the preliminary programming document for 2027-2029.
A GOVERNANCE STRUCTURE FOR THE IMPLEMENTATION OF THE NEW PHARMACEUTICAL LEGISLATION, ONCE
ADOPTED
The Board adopted a governance structure to guide and oversee EMA’s implementation of the
pharmaceutical legislation and its impact on the network. A new group, including representatives from
EMA, the Management Board and the European Commission, will oversee work across workstreams on
the centralised procedure and committees, development support, environmental risks, quality and
manufacturing, shortages and other regulatory and legal aspects. Both the centralised
procedure/committee and development support workstreams will also include civil society representatives
(patients and healthcare professionals). This integrated approach aims to ensure close coordination
between EMA, the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance
Risk Assessment Committee (PRAC) and the Coordination Group for Mutual
Recognition and Decentralised Procedures (Human) (CMDh), the Commission, the European medicines
regulatory network and stakeholders, throughout the implementation of the new legislation.
OTHER NEW PIECES OF LEGISLATION
The Commission updated the Board on the proposals for a revision of the Medical Device Regulation
((EU) 2017/745) and the In Vitro Diagnostic Medical Device Regulation ((EU) 2017/746), which assign
new responsibilities to EMA regarding the management of medical device expert panels, to work with the
Commission to set up and manage an IT system for reporting and sharing information on supply
interruptions or discontinuation of critical medical devices, and to provide support to the national
Medicines
https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2025-meeting
https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation
https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation
AESGP OTC News | January 2026 4 | 23
competent authorities for medical devices to facilitate the exchange of experience, cooperation and
coordination in certain areas. The Board also welcomed the publication of the Commission's proposed
Biotech Act, which is designed to further boost biotech innovation and research in the EU and includes
several amendments to the EU Clinical Trials Regulation.
DATA AND ARTIFICIAL INTELLIGENCE IN MEDICINES REGULATION
In the first half of 2026, EMA will launch a competitive tender to extend the work of the Data Analysis and
Real World Interrogation Network (DARWIN EU) from 2027 to 2032.
The Board also noted the recent activities of the network data steering group. The first data strategy
for medicines regulation has been published, outlining a clear approach to ensure that the European
medicines regulatory network data assets are well-governed, meet high standards of quality and deliver
value to stakeholders. In addition, agreement on a proposal for data training, including modules on artificial
intelligence, will be rolled out to the network starting in the first quarter of 2026, through the EU Network
Training Centre Learning Management System.
TECHNOLOGY CAPABILITY INVESTMENT PLAN TO 2028
The Board noted EMA’s technology capability investment plan to 2028, which sets the strategic
direction for achieving the technology objectives of the network and its stakeholders in the coming years.
The plan addresses information management needs arising from strategic requirements as well new
pieces of legislation, such as the new pharmaceutical legislation, and supports the development of a fully
digital, efficient and data-driven network. The plan will serve as a guideline for EMA’s technology
investment and selection and is published on the EMA website.
EMA Consolidated 3-year rolling work plan for the
Non-clinical domain 2026-2028
On 9 December, the EMA published the consolidated 3-year rolling work plan for the Non-clinical
domain, covering the period from January 2026 to December 2028, with an initial review scheduled after
the first year to assess progress and make any necessary updates.
Consolidated 3-year rolling work plan for the Non-clinical domain 2026-2028 is structured around
three main pillars:
1. Strategic goals,
2. Tactical goals (including guidance, training and workshop activities), and
3. Operational goals of the Joint NcWP-3RsWP, NcWP and 3RsWP.
EMA consultation on ICH E22 Guideline on
general considerations for patient preference
studies
The European Medicines Agency has published for public consultation the ICH E22 Guideline on general
considerations for patient preference studies.
Patient preference studies (PPS) aim to assess the relative desirability or acceptability of actual or
potential health interventions, or their characteristics and outcomes. PPS can generate structured insights
about the relative importance of characteristics, also referred to as attributes, that are considered by
patients when making decisions about drugs. These attributes may include, for example, efficacy or safety
outcomes or any other potentially relevant characteristics.
https://commission.europa.eu/news-and-media/news/commission-proposes-new-measures-improve-health-and-healthcare-sector-2025-12-16_en
https://commission.europa.eu/news-and-media/news/commission-proposes-new-measures-improve-health-and-healthcare-sector-2025-12-16_en
https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence/data-analysis-real-world-interrogation-network-darwin-eu
https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence/data-analysis-real-world-interrogation-network-darwin-eu
https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/network-data-steering-group-ndsg
https://www.ema.europa.eu/en/documents/other/european-medicines-agencies-network-data-strategy-increasing-value-data-benefit-public-animal-health_en.pdf
https://www.ema.europa.eu/en/documents/other/european-medicines-agencies-network-data-strategy-increasing-value-data-benefit-public-animal-health_en.pdf
https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/eu-network-training-centre-eu-ntc
https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/eu-network-training-centre-eu-ntc
https://www.ema.europa.eu/en/about-us/how-we-work/information-management#technology-capability-investment-plan-11825
https://www.ema.europa.eu/en/documents/other/consolidated-3-year-rolling-work-plan-non-clinical-domain-2026-2028_en.pdf
https://www.ema.europa.eu/en/documents/other/consolidated-3-year-rolling-work-plan-non-clinical-domain-2026-2028_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e22-guideline-general-considerations-patient-preference-studies-step-2b_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e22-guideline-general-considerations-patient-preference-studies-step-2b_en.pdf
AESGP OTC News | January 2026 5 | 23
This guideline outlines general considerations about the use, design, conduct, analysis, and submission
of PPS aimed at informing drug development, regulatory submission and evaluation, drug approvals and
maintenance of such approvals. It addresses PPS and the value that patients place on characteristics of
drugs.
Multistakeholder workshop on Patient Registries
for Alzheimer’s Disease on 15 DEC 2025 -
Summary and recording of the event
The EMA has published the Summary of the Joint HMA/EMA multistakeholder workshop on Patient
Registries for Alzheimer's disease, which took place on 15 December 2025.
Some highlights from the workshop include:
• Broad agreement on the need to define a common core dataset for Alzheimer’s disease registries
that is acceptable to all stakeholders and aligned with EMA’s data quality framework.
• The importance of involving patients and caregivers in the definition of registry data to ensure that
outcomes collected are meaningful to them.
• The need for secure, transparent data collection and sharing to build trust and encourage
engagement.
• Support for moving towards large, disease-based registries enabling comparisons across
treatments, patient populations, and countries.
• Recognition of the need for sustainable, long-term funding models under clear governance
frameworks, involving both public institutions and industry.
• Interest in further exploring the use of digital tools and data linkage to complement registry data
and reduce burden on clinicians and patients.
Additionally, several EU-wide initiatives were highlighted, namely the upcoming European Partnership for
Brain Health, and the ACCESS-AD project, which aim to create a pan-European registry for Alzheimer's
disease and to facilitate dialogue between all stakeholders.
For the full summary, please refer to the event page. The recording of the workshop and the presentation
slides used on the day are also available on the page.
CMDh Meeting Report - 9-11 DEC 2025
The report from the CMDh meeting held on 9-11 DEC 2025 has been published. Among the items
reported, the following may be noted:
NITROSAMINES CALL FOR REVIEW
MAHs are reminded of their responsibilities to ensure the quality, safety and efficacy of their medicines
and to adhere to the Nitrosamines guidance outlined by the EMA and the CMDh. This includes the
obligation to monitor and mitigate nitrosamine risks throughout the lifecycle of their products.
MAHs are expected to conduct confirmatory testing for all products at risk for which an AI is published in
Appendix I, unless it can be justified that the N-nitrosamine cannot be formed in their product. This should
be thoroughly discussed according to appropriate scientific principles. For example, where an AI is
recently published it is expected that the MAH who has products containing that active substance performs
confirmatory testing to determine the level of nitrosamine in their product. The outcome of the risk
assessment should be notified to the relevant competent authorities as a matter of priority, by using the
dedicated response templates. If N-nitrosamines are detected above the AI a quality defect report should
be submitted as well.
The implementation of CAPAs and submission of step 3 responses should be done at the earliest
opportunity, but no later than 3 years from the date of publication of the initial AI. This deadline has elapsed
or is approaching for a large number of N-nitrosamines included in Appendix I. MAHs are requested to
https://www.ema.europa.eu/en/documents/report/summary-joint-hma-ema-multi-stakeholder-workshop-patient-registries-alzheimers-disease-december-2025_en.pdf
https://www.ema.europa.eu/en/documents/report/summary-joint-hma-ema-multi-stakeholder-workshop-patient-registries-alzheimers-disease-december-2025_en.pdf
https://www.brainhealth-partnership.eu/
https://www.brainhealth-partnership.eu/
https://www.ema.europa.eu/en/events/joint-heads-medicines-agencies-hma-european-medicines-agency-ema-multistakeholder-workshop-patient-registries-alzheimers-disease
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2025/CMDh_press_release_-_December_2025.pdf
AESGP OTC News | January 2026 6 | 23
actively inform NCAs about the status of CAPA implementation. If it is expected that products cannot be
brought in compliance within this 3-year period, this should be discussed with the concerned authorities
without delay.
Compliance of MAHs with the above-mentioned requirements is subject to regular controls by competent
authorities, including during GMP inspections.
CMDH BEST PRACTICE GUIDE ON VARIATION WORKSHARING
The CMDh agreed an update of 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”.
The revised Best Practice Guide on Variation Worksharing (Chapter 7) [clean version] and [track
version] have been published on the CMDh website. The update was introduced to Section 6.1,
“Submission and documentation requirements.”
Please also be informed that the draft minutes from the CMDh meeting held on 11-13 NOV 2025 has
been published. Among the items reported, the following may be noted:
2.1.2. WORKING PARTY ON PHARMACOVIGILANCE PROCEDURES WORKSHARING
The WP Chair informed the CMDh about the NAPs entries removed from the EURDlist and members were
reminded to review the list. The WP adopted the LoSC for several products while awaiting the new web-
based system for its publication.
The CMDh was informed about the ongoing work of the temporary group created to improve the
implementation of patient cards after a referral procedure.
2.5. HMA TASK FORCE ON MONITORING HORIZONTAL LEGISLATION
The Chair emphasized the importance of having a CMDh representative present at the meetings of the
HMA task force on monitoring horizontal legislation.
[Post-meeting note: Laura Galatti (IT) agreed to be nominated as CMDh representative in the HMA task
force on monitoring horizontal legislation.]
2.7. CMDH MULTI-ANNUAL WORKPLAN (MAWP)
The agreed action points will be incorporated into the draft CMDh MAWP for 2028 and will undergo further
review to ensure consistency throughout the document.
2.7.1. SLOT BOOKING/PREDICTABILITY ON SUBMISSIONS
The CMDh discussed the draft action points for the MAWP on slot booking/predictability on submissions.
HU will share the final version of the document including the key performance indicators
2.7.5. TRANSPARENCY ON SAFETY OUTCOMES FOR NAPS
The CMDh agreed on the action points for the MAWP for transparency on safety outcomes for NAPs,
including the publication of CMDh guidance how to deal with aRMM in MRP/DCP.
2.7.8. CLOCK-STOP IN DCP
The DG discussed the results of a survey initiated by NL last year and concluded that no action point could
be defined at this stage. MSs were reminded to adhere to the SOP on the decentralised procedure. The
clock-stop in DCP will be considered for further discussion in the future, upon adoption of the new
pharmaceutical legislation. The CMDh agreed not to include this topic in the new MAWP.
3.1.1. (PUBLIC) ASSESSMENT REPORT TEMPLATES
Following the publication of the update of the DCP D70 Overview assessment report template including
instructions, to include further standardised wording to guide assessors, after the October CMDh meeting,
the CMDh now also agreed related updates to the DCP D70 Overview assessment report template
(empty), the PAR template (empty) when prepared based on the FAR and the instructions for the RMS
when preparing the PAR based on the FAR.
The rapporteurs also discussed if the questions related to the applicant’s part of the ASMF could be cross-
referred from the Overview AR and Quality AR templates, but it was decided to keep them in both
templates to avoid that these are potentially overlooked.
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.35_2025_12_clean_-_Chapter_7_-_BPG_on_Worksharing.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.35_2025_12_TC_-_Chapter_7_-_BPG_on_Worksharing.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_297_2013_Rev.35_2025_12_TC_-_Chapter_7_-_BPG_on_Worksharing.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Agendas_and_Minutes/Minutes/2025_11_CMDh_Minutes.pdf
AESGP OTC News | January 2026 7 | 23
[Post-meeting update: The revised D70 Overview AR Template (empty) - [clean version] and [track
version], PAR template (empty) - when prepared based on FAR, and Instructions for RMS when
preparing the PAR based on the FAR have been published on the CMDh website.]
3.2.1. IMPLEMENTATION OF UPDATED VARIATIONS GUIDELINES
The two-way approach proposed by MfE was not supported by CMDh and EMA. Instead, the published
approach should be followed (i.e. all type IA variations implemented before 15 January 2026 should be
submitted before 15 January 2026 according to the EC Variations Guidelines (2013), and type IA variations
implemented as of 15 January 2026, should be submitted according to the EC Variations Guidelines
(published in 2025)). It was highlighted that guidance to prepare for the EC Variations Guidelines
(published in 2025) was communicated in a timely manner by CMDh and EMA, allowing MAHs to make
the necessary preparations. The CMDh supported a proposal for MAHs to “freeze” the implementation of
type IA variations until 15 January 2026 as needed and noted that type IA variations implemented from 15
January 2026 should follow the new EC Variations Guidelines (published in 2025).
3.10. MOBILE SCANNING TECHNOLOGIES INCLUDED IN LABELLING AND PL
The CMDh discussed an update of the CMDh position paper on the use of mobile scanning and other
technologies to be included in the labelling and/or package leaflet in order to provide information about
the medicinal product and the related template for the applicant declaration (annex 2). The document has
been updated in line with an ongoing update of the related guidance in the centralised procedure.
Comments from MSs were discussed and agreed in the meeting, as appropriate. The CMDh agreed a
final version of the update of the documents, however, before the document is finalised, feedback from
the EC on a question raised by the QRD group is still pending. The document will be brought back to the
CMDh for final adoption once the QRD discussions have concluded.
4.2. NEED TO SUBMIT BIOEQUIVALENCE STUDIES FOR GENERIC IF QUALITATIVE AND QUANTITATIVE IDENTICAL TO
REFMP
AT asked the CMDh if for abridged applications the applicant has to provide a BE study if they provide
proof that the product applied for and the RefMP are identical (same manufacturer, manufacturing
site/process…). In the example provided by AT, the applicant and the MAH of the RefMP are independent
companies, but the applicant has provided a letter of access from the MAH of the RefMP allowing access
to the quality dossier. It was noted that the RefMP is not authorised in all CMSs where the abridged
application has been submitted, therefore an informed consent application would not be possible. In the
past, the CMDh has discussed similar cases where the generic applicant and the MAH of the RefMP
belonged to the same company. In such cases, the CMDh had agreed that BE studies are not required.
The CMDh agreed that also in the case where the applicant and the MAH of the RefMP are different
companies a BE study is not required as long as sufficient proof is provided that both products are
identical.
8.3.2. UPDATE OF EU-US MUTUAL RECOGNITION AGREEMENT
The CMDh was informed of the GMP/GDP Inspectors Working Group agreement as of 1 October 2025 to
implement the provision given in Article 8 of the EU-US MRA allowing to rely on certain non-domestic US
FDA inspections. The relevant parts of the Q&As published on the EMA MRA website have been updated
accordingly.
In practical terms, the Supervisory Authority (GMP inspectorate) responsible for inspecting the third
country site should be consulted by the RMS to determine if and to what extent an FDA inspection could
be used to confirm the GMP compliance status of the third country manufacturer.
The CMDh internal guidance document on the impact of the EU-US Mutual Recognition Agreement on
marketing authorisation applications and relevant variations has been updated to reflect the update of the
EU-US MRA and the update of the EMA Q&As. In addition, further amendments have been implemented
in line with current practice. The CMDh agreed with the update. It was agreed to move the internal
guidance document from Eudraportal to MMD.
8.3.8. XEVMPD / EMA
The EMA requested feedback from MSs related to timelines for the submission of updates to XEVMPD
when there are variations in MRPs and DCPs.
It was clarified that NCAs should communicate to MAHs whether Type IA notifications are accepted or
rejected within 30 days following receipt. For MRP/DCP procedures, it is the task of the RMS to inform the
MAH in his country (via email) and the concerned Member States (via CTS) of the outcome of its review.
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_200_2007_Rev13_2025_11_clean_-_D70_Overview_AR.docx
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_200_2007_Rev13_2025_11_TC_-_D70_Overview_AR.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/DCP_AR_Comments/CMDh_200_2007_Rev13_2025_11_TC_-_D70_Overview_AR.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_453_2025_Rev1_2025_11_clean_-_Empty_PAR_template_when_the_PAR_is_prepared_based_on_the_FAR.docx
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_454_2025_Rev1_2025_11_clean_-_Instructions_for_RMS_when_preparing_the_PAR_based_on_the_FAR.docx
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/AR/Public_AR/CMDh_454_2025_Rev1_2025_11_clean_-_Instructions_for_RMS_when_preparing_the_PAR_based_on_the_FAR.docx
AESGP OTC News | January 2026 8 | 23
This MAH is obliged to inform all other MAHs involved. Some CMSs may also be issuing approval letters,
but this is voluntary. It is also not recommended to wait for CMSs approvals as this is not foreseen in the
legislation. The procedure is considered closed in all Member States with the notification of the outcome
by the RMS.
8.3.9. CMDH BPG ON THE COMPILATION OF THE DOSSIER FOR NEW MAAS SUBMITTED IN MRP/DCP
The CMDh agreed an update of its BPG on the compilation of the dossier for new applications submitted
in MRP & DCP to include a strong recommendation that applicants in DCP use the RMS validation
checklist for DCP as a ‘self-assessment’ tool prior to dossier submission (see also 8.3.1.). The document
has also been updated to include information on the need to provide bridging data in Art. 10a applications.
Other minor/editorial changes have been included.
[Post-meeting update: The revised CMDh Best Practice Guide on the compilation of the dossier for
New Applications submitted in Mutual Recognition and Decentralised Procedures [clean
version] and [track version] have been published on the CMDh website.]
8.3.10. Regulatory Optimisation Group (ROG)
DE reported from the ROG meeting held on 20 October 2025. DE briefed the CMDh on the ongoing
discussions in the group, such as the ongoing PMS feasibility study and the priorities and lessons learned
identified by industry as well as two projects on type IA variations (pilot for digital submissions and deletion
of the cover letter).
Shortages - Union list of critical medicines v2.1 –
Publication
The EMA has published the revised Union list of Critical Medicines v2.1.
The corresponding Q&A document has also been revised.
For more information, the dedicated EMA website is available.
Shortages - Publication of shortages reporting
obligations factsheets and updated ESMP Q&A
document
The EMA has published two new factsheets clarifying the shortages reporting obligations of industry
via the ESMP:
• Factsheet - Industry reporting via the European Shortages Monitoring Platform (ESMP) in normal
circumstances
• Factsheet - Industry reporting via the European Shortages Monitoring Platform (ESMP) during a
crisis or MSSG-led preparedness action
For more information, please refer to the newly dedicated EMA page – European Shortages Monitoring
Platform (ESMP): Guidance, training materials and events.
Additionally, please be informed that the Frequently asked questions document on the European
Shortages Monitoring Platform (ESMP) has been updated to reflect changes below:
• Minor wording updates have been made throughout the document to reflect the current status of
activities (e.g., adjustments to verb tenses)
• Updated and renamed Section 5: Platform development activities
• Addition of questions 2.2 (Are personalised medicines, like autologous ex vivo therapies, in scope
of shortage reporting via the ESMP?), 2.5 (Should shortages be reported only if they are of a
specific duration, or is reporting also required for shortages lasting as little as one day?), and 3.5
(I have the Industry User role but I cannot see all the products of my organisation. What can I
do?)
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_077_Rev6_November_2025__clean__BPG_on_the_compilation_of_the_dossier.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_077_Rev6_November_2025__clean__BPG_on_the_compilation_of_the_dossier.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_077_Rev6_November_2025__clean__BPG_on_the_compilation_of_the_dossier.pdf
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_077_Rev6_November_2025_TC_BPG_on_the_compilation_of_the_dossier.pdf
https://www.ema.europa.eu/en/documents/other/questions-answers-union-list-critical-medicines_en.pdf
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/availability-medicines-during-crises/union-list-critical-medicines
https://www.ema.europa.eu/en/documents/other/factsheet-industry-reporting-european-shortages-monitoring-platform-esmp-normal-circumstances_en.pdf
https://www.ema.europa.eu/en/documents/other/factsheet-industry-reporting-european-shortages-monitoring-platform-esmp-normal-circumstances_en.pdf
https://www.ema.europa.eu/en/documents/other/factsheet-industry-reporting-european-shortages-monitoring-platform-esmp-during-crisis-or-mssg-led-preparedness-action_en.pdf
https://www.ema.europa.eu/en/documents/other/factsheet-industry-reporting-european-shortages-monitoring-platform-esmp-during-crisis-or-mssg-led-preparedness-action_en.pdf
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platform-esmp/european-shortages-monitoring-platform-esmp-guidance-training-materials-events
https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platform-esmp/european-shortages-monitoring-platform-esmp-guidance-training-materials-events
https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-european-shortages-monitoring-platform-esmp_en.pdf
https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-european-shortages-monitoring-platform-esmp_en.pdf
AESGP OTC News | January 2026 9 | 23
• Update of questions and answers 1.6 (What is the link between the Union list of critical medicines
and reporting requirements in ESMP?) , 5.1 (How was the ESMP developed and when was it
launched?), and 5.2 (Will further functionalities be added to the ESMP?)
• Move of question 5.4 (What APIs for machine-to-machine communication with the ESMP are
available?) to be 2.22, and update of question and answer
Please note that the reporting obligations of MAHs via the ESMP have not changed, and that the
purpose of these updates is to clarify certain common questions of industry and improve the document in
terms of readability.
Also please note that these obligations may evolve in the context of the revision of the general
pharmaceutical legislation.
Shortages - Publication of the SPP and SMP pilot
report by the EMA
The EMA has published the Shortage Prevention Plan (SPP) and Shortage Mitigation Plan (SMP)
pilot report, summarising the outcome of the pilot conducted between DEC 2024 and SEP 2025.
The pilot aimed to enable MAHs and NCAs to cooperate on the harmonised implementation of
SPPs and SMPs, and to collect feedback on the use of EMA-provided templates, including challenges
and opportunities for improvement.
Key findings from the pilot include:
• Variable quality and level of detail of SPP submissions, with challenges identified in terms of clarity,
standardisation and comparability of information;
• Limited usefulness of SMP submissions, as they were not linked to active shortages, highlighting the
need for clearer guidance on their intended use;
• Feedback from MAHs indicating that, while the exercise was considered valuable, the templates were
perceived as time-consuming, particularly with regard to supply chain risk assessment, and would
benefit from further clarification to reduce interpretation variability.
According to the elements agreed at trilogue level (as outlined in the SANT background note), the revised
pharmaceutical legislation foresees an obligation for MAHs to establish and keep updated SPPs for
prescription-only medicines and for other medicinal products identified by the Commission through
delegated acts. These elements remain subject to revision of the legal texts following the provisional
agreement, legal checks and final adoption.
EMA-FDA joint guiding principles for good AI
practice in the medicines lifecycle
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have jointly
released ten guiding principles for good artificial intelligence (AI) practice in the medicines
lifecycle.
These principles provide high-level guidance on the use of AI in evidence generation and monitoring
throughout all phases of a medicine’s lifecycle, from early research and clinical trials to manufacturing and
safety monitoring. They are relevant for medicine developers, as well as for marketing
authorisation applicants and holders.
The ten guiding principles are:
1. Human-centric by design
2. Risk based approach
3. Adherence to standards
https://www.ema.europa.eu/en/documents/other/shortage-prevention-plan-spp-shortage-mitigation-plan-smp-pilot-report_en.pdf
https://www.ema.europa.eu/en/documents/other/shortage-prevention-plan-spp-shortage-mitigation-plan-smp-pilot-report_en.pdf
https://www.europarl.europa.eu/news/en/press-room/20251209IPR32111/background-note-pharmaceutical-package-provisional-agreement-elements
https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0
https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0
AESGP OTC News | January 2026 10 | 23
4. Clear context of use
5. Multidisciplinary expertise
6. Data governance and documentation
7. Model design and development practices
8. Risk-based performance assessment
9. Life cycle management
10. Clear, essential information
These principles are intended as a foundation for future regulatory guidance and will be complemented
over time by additional EU and US initiatives, taking into account applicable legal requirements and
evolving legislation. Guideline development in the European Union (EU) is already underway, building on
the EMA AI reflection paper published in 2024.
Herbal medicines
EMA HMPC Meeting Report - 17-19 NOV 2025
The report on European Union herbal monographs, guidelines, and other activities from the
EMA Committee on Herbal Medicinal Products (HMPC) meeting held on 17-19 November 2025 has
been published.
Among the reported items, the following may be noted:
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 new data were detected that could change the monograph’s content:
• EU herbal monograph on Equiseti herba
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 Althaeae radix
• EU herbal monograph on Carvi aetheroleum
• EU herbal monograph on Carvi fructus
• EU herbal monograph on Cimicifugae rhizoma
• EU herbal monograph on Curcumae longae rhizome
• EU herbal monograph on Oenotherae oleum
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 January 2026 meeting)
NEW ASSESSMENTS – FINAL
• Hyperici herba/Cimicifugae rhizoma
MONOGRAPH REVISIONS – DRAFT
• Ribis nigri folium
MONOGRAPH REVIEWS
• Betulae folium
• Hamamelidis cortex
• Hamamelidis folium
• Hamamelidis folium et cortex aut ramunculus destillatum
• Passiflorae herba
https://www.ema.europa.eu/node/244999#ai-in-medicinal-product-lifecycle-reflection-paper-68368
https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-17-19-november-2025_en.pdf
https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-17-19-november-2025_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/procedure-review-and-revision-european-union-herbal-monographs-and-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
AESGP OTC News | January 2026 11 | 23
The HMPC September meeting minutes have also been published.
https://www.ema.europa.eu/en/documents/minutes/minutes-hmpc-meeting-22-24-september-2025_en.pdf-0
AESGP OTC News | January 2026 12 | 23
Risk Assessment
EFSA Scientific opinion on the tolerable upper
intake level for supplemental docosahexaenoic
acid (DHA)
EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has finalized and published its
scientific Opinion on the tolerable upper intake level for supplemental docosahexaenoic acid.
In its 2012 opinion, EFSA concluded that a Tolerable Upper Intake Level for DHA could not be established.
However, the Panel noted that supplemental intakes of EPA and DHA combined at doses up to 5 g/day,
and supplemental intakes of EPA alone up to 1.8 g/day, did not raise safety concerns for the adult
population. The Panel also considered that supplemental intakes of DHA alone up to about 1 g/day did
not raise safety concerns for the general population (safe level of intake).
The Panel considers that the available data are not sufficient to establish a UL for supplemental DHA
alone for any population group.
Based on the data available, the Panel concludes that supplemental intakes of DHA alone up to 1 g/day
do not raise safety concerns for the general population and retains the previously established safe level
of intake of 1 g/day for all population groups (i.e., infants, children, adolescents and adults, including
pregnant and lactating women), as set in 2012.
The safe level of intake applies to DHA added to foods or consumed as food supplements in any chemical
form (e.g. tri-acylglycerols, ethyl esters, phospholipids) from sources (e.g. fish oil concentrates, algal oils,
krill oils) containing DHA alone or mostly DHA (i.e. EPA/DHA ratio < 0.3).
Food
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9858
AESGP OTC News | January 2026 13 | 23
MDR/IVDR Implementation
Overview on Applications for Designation as a NB
- Update 02 December 2025
The overview on the applications for designation as a notified body under the MDR and IVDR has
been updated by the Commission.
The updated overview is accessible here.
The presentation indicates that there are 51 designations of notified bodies in the NANDO database
under the MDR while there are 52 MDCG recommendations. It is therefore expected that the number
of notified bodies designated under the MDR will increase soon to 52 together with the corresponding
update of the NANDO database.
Simplification Proposal - Publication of EC
Legislative Proposal
The European Commission published its legislative proposal for amending the MDR and IVDR as
regards simplifying and reducing the burden of the rules on medical devices and IVDs on 16 December
2025.
The legislative proposal and accompanying documents are accessible via the following links:
• Proposal for a regulation to reduce and simply rules on medical and in vitro diagnostic
devices
o Act
o Annex
• Staff working document on cost-savings for the proposal to reduce and simplify
regulations on medical and diagnostic devices
• Evaluation of medical and diagnostic device regulations for the proposal to simplify and
lessen regulatory burdens
o Evaluation
o Resumé
• Questions and answers on simpler and more effective rules for medical devices
• Factsheet: Medical Devices
The proposal aims to streamline and future-proof the regulatory framework. Its main objective is to simplify
applicable rules, reduce the administrative burden on manufacturers and enhance the predictability and
cost-efficiency of the certification procedure by notified bodies, while preserving a high level of public
Medical
Devices
https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf
https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf
https://health.ec.europa.eu/document/download/dc018bdb-8c09-4a2e-8763-043b594703f7_en?filename=md_com_2025-1023_annex_en.pdf
https://health.ec.europa.eu/document/download/94299481-f705-4918-9c64-8fd1d2ac2cb5_en?filename=md_swd-2025-1050_en.pdf
https://health.ec.europa.eu/document/download/94299481-f705-4918-9c64-8fd1d2ac2cb5_en?filename=md_swd-2025-1050_en.pdf
https://health.ec.europa.eu/document/download/ef4d9af7-78a7-4e7f-8f78-50cdc910db93_en?filename=md_com_2025-1023_evaluation_en.pdf
https://health.ec.europa.eu/document/download/bca0b072-c6b7-482d-8bcb-1119e667b64d_en?filename=md_com_2025-1052_evaluation-resume_en.pdf
https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_25_3078/QANDA_25_3078_EN.pdf
https://ec.europa.eu/commission/presscorner/api/files/attachment/882087/FACTSHEET%20medical%20devices%20final%20(1).pdf
AESGP OTC News | January 2026 14 | 23
health protection and patient safety. It builds on the key features of the existing framework, notably the
decentralised approach (whereby responsibilities are allocated to the Member States) and the involvement
of notified bodies in the conformity assessment procedure, like in other EU legislation based on the New
Legislative Framework. However, the aim is to establish a leaner and more cost-effective regulatory
framework and to promote further harmonisation, creating a more competitive and innovative EU market.
AESGP organized an info session for its members on 15 January detailing relevant amendments included
in the legislative proposal revising the MDR.
52th NB Designated under MDR
The Malta-based Notified Body ‘Malta Conformity Assessment Ltd.’ has been notified as the 52th
Notified Body under the MDR.
Simplification Proposal - Feedback procedure
opened
The European Commission has launched a feedback procedure that is opened for 8 weeks regarding the
legislative proposal for amending the MDR and IVDR. The eight-week feedback period is being extended
every day until this adopted proposal is available in all EU languages.
Study on Governance & Innovation - Publication
of Final Report
The final report of the “Study on regulatory governance and innovation in the field of medical
devices”, developed by EY for the European Commission, has been published on the “Publication Office
of the European Union”:
• Final report
• Annexes
• Executive summary
The study was commissioned in 2023 to provide mainly qualitative input through specific desk research,
stakeholder consultations and other activities related. As highlighted in the past, the study aims to map
the key benefits and challenges of the regulatory governance structure of the MDR/IVDR and look at their
impact on innovation and patient safety in the EU medical devices sector. The output of the study was
also taken into duly account in the development of the Commission proposal for a targeted revision of the
medical devices regulations and its accompanying and supporting documents, as published on 16
December 2025.
EMA's COMBO Meeting Report - 7 NOV 2025
Two highlight reports from the EMA’s Combination Products Operational Group (COMBO)
meetings have been published:
• The report from the In Vitro Diagnostics (IVD) stream, covering the meeting held on 4 NOV
2025.
• The report from the Medical Devices (MD) stream, covering the meeting held on 7 NOV 2025.
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en
https://op.europa.eu/en/publication-detail/-/publication/822e7d4c-e077-11f0-8439-01aa75ed71a1/language-en
https://op.europa.eu/en/publication-detail/-/publication/798e321e-e076-11f0-8439-01aa75ed71a1/language-en
https://op.europa.eu/en/publication-detail/-/publication/f0bde7f0-e078-11f0-8439-01aa75ed71a1/language-en
https://www.ema.europa.eu/en/documents/report/highlight-report-combination-products-operational-group-combo-vitro-diagnostics-stream_en.pdf
https://www.ema.europa.eu/en/documents/report/highlight-report-combination-products-operational-group-combo-medical-devices-stream_en.pdf
AESGP OTC News | January 2026 15 | 23
The published highlight report pertaining to the Medical Devices stream is composed of four items.
Among the reported items, the following may be noted:
2. DISCUSSION AND AGREEMENT ON THE TERMS OF REFERENCE (TORS)
EMA has presented the draft ToRs outlining the scope, objectives, composition, and organisational
aspects for operating the group. The group’s primary objectives are to establish a shared
understanding of technical and procedural challenges related to combination products and consultation
processes, and to collaboratively explore potential solutions within the existing framework, with the aim of
developing and updating relevant guidance.
The draft ToRs were reviewed and endorsed by both streams, and the final terms of reference have been
published on the EMA website.
3. COLLECTION AND PRIORITISATION OF TOPICS
Several topics have been identified for further development and discussion in the upcoming COMBO
meetings. Key areas of focus include:
• Consultation procedure for ancillary medicinal substances: Reflection on harmonisation and
scope of assessment by competent authorities, as well as clarification of dossier requirements and
structure.
• Notified body opinion for integral devices: Review of current experience and
clarification/harmonisation of elements covered in notified body opinions, along with streamlining the
scope of review between the notified body opinion and the marketing authorisation application.
Subsequently, it is foreseen to touch upon ‘platform approach’ regarding a device with the ‘re-use’ of
notified body opinion.
• Co-packaged devices: Particular attention to labelling aspects.
EMA's Combination Products Operational Group -
Publication of ToRs
The EMA’s Combination Products Operational Group (COMBO) has published its Terms of Reference
(ToRs). Please find below a short summary of the key points.
Scope – Which products are covered?
• Medicines with an integral device
• Medicines with a co-packaged device
• Medicines intended for exclusive use with a separately supplied device
• Medical devices with an ancillary medicinal substance
• Substance-based medical devices that are systemically absorbed
Objectives and responsibilities
The COMBO group provides a forum for regular dialogue on technical and procedural issues related to
combination products. It focuses on sharing experiences, improving mutual understanding, and exploring
solutions within the current EU legal framework. COMBO complements existing groups (e.g., MDCG sub-
groups), and when an issue falls under another body’s remit, it forwards its conclusions for further
consideration.
Composition & organizational matters
• The group includes experts from the EMA, NBCG-Med, Medicines CAs, MD CAs, and the EC, with
participation based on expertise and need.
• Engagement with Industry stakeholders is foreseen through the Industry platforms meetings or, as
appropriate, interested parties meetings.
• The COMBO may establish sub-groups or task forces for specific technical topics.
• Meeting will be held quarterly, with agendas and highlights of the meetings published on the EMA
website.
The COMBO ToRs will be reviewed as needed, particularly in light of changes in scope, role, or evaluation
parameters.
https://www.ema.europa.eu/en/documents/other/combination-products-operational-group-combo-terms-reference_en.pdf
https://www.ema.europa.eu/en/documents/other/combination-products-operational-group-combo-terms-reference_en.pdf
https://www.ema.europa.eu/en/documents/other/combination-products-operational-group-combo-terms-reference_en.pdf
AESGP OTC News | January 2026 16 | 23
Publication of MDR-IVDR consolidated versions
with proposed amendments integrated
The European Commission has now published the consolidated versions of the MDR and IVDR (and their
annexes), integrating the changes as proposed in the Commission proposal COM(2025)1023 final of 16
December 2025. These consolidated texts are non-official working documents and therefore have no
legal effect.
• MDR – Articles – Annexes
• IVDR – Articles – Annexes
Certain differences between these consolidated versions and the Commission proposal (for
example, Article 56(2) on the validity of certificates) have been identified. Only the text of the
Commission proposal COM(2025)1023 as published on EUR-LEX has legal effect.
Guidance on Breakthtrough Devices (BtX)
Regulations 2017/745 & 2017/746
The Commission has published the MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under
MDR and IVDR on its website.
This document provides guidance for manufacturers, expert panels and notified bodies on the process
and regulatory considerations relevant for qualifying, assessing and certifying breakthrough medical
devices and breakthrough IVDs. It describes some key roles of actors in this context, including EMA
expert panels and national competent authorities, and outlines the supports and opportunities
available to manufacturers of BtX. This guidance also provides considerations on the clinical evaluation /
performance evaluation of BtX, as well as the role of non-clinical data and preclinical evaluation, and post-
market clinical follow-up / performance follow-up for these devices. This guidance document may apply
to medical devices and IVDs across all technologies and risk classifications. Custom-made
devices, in-house devices, and products listed in MDR Annex XVI without an intended medical purpose
are outside the scope of this guidance.
TEAM NB Position Paper on SARS-CoV-2
Test down-classification V1
The IVD designated NBs endorsed a paper on Considerations for conformity assessments done by
NBs in the case of down classification of SARS-CoV-2 tests, including operational aspects and
Q&A parts.
Annex VII
Commission implementing regulation draft -
TEAM NB position paper
https://health.ec.europa.eu/document/download/7c4e871e-ebaf-46e0-ae76-93478e3d3fbc_en?filename=md_sector_proposed-amendments-mdr-articles.pdf
https://health.ec.europa.eu/document/download/9224b81e-4d45-4ff7-8cf0-97cacf3ec3b0_en?filename=md_sector_proposed-amendments-mdr-annexes.pdf
https://health.ec.europa.eu/document/download/d4821ee8-a337-481b-8b96-de38c524d5ff_en?filename=md_sector_proposed-amendments-ivdr-articles_0.pdf
https://health.ec.europa.eu/document/download/f711e867-ee14-4c75-b7e8-7eb0cf68d486_en?filename=md_sector_proposed-amendments-ivdr-annexes_0.pdf
https://eur-lex.europa.eu/search.html?DTA=2025&SUBDOM_INIT=PRE_ACTS&DB_TYPE_OF_ACT=com&DTS_SUBDOM=PRE_ACTS&typeOfActStatus=COM&type=advanced&qid=1766073999157&DTN=1023
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec13
https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-IVD-SARS-CoV-2-down-classification-V1-20251212.pdf
AESGP OTC News | January 2026 17 | 23
Following the release of the Commission’s proposal of 12 December 2025 to amend Annex VII, Team-
NB has released the full version of their position paper regarding the release of of the Commission’s
proposal of 12 December 2025 to amend Annex VII.. Please find below the key elements extracted from
it.
NBs have identified several challenges and risks associated with the proposal:
• Complexity and Feasibility: The proposal introduces different timelines for initial certification and
changes. This creates unnecessary complexity for NBs, making implementation and monitoring
more difficult, especially given the diversity of device types and NB processes.
• Resource Constraints: Some timelines, particularly for technical documentation (TD)
assessment and decision-making, are considered unrealistic. NBs highlight that these steps often
require multiple reviewers with specialized expertise, and that shorter deadlines could
compromise quality, limit training opportunities for new staff, and increase costs.
• Operational Flexibility: The proposal does not sufficiently account for the need for flexibility in
handling complex or high-risk devices, or for parallel processing of multiple submissions.
• Transition timelines: these are considered too short and should be replaced by realistic timelines
European UDI WG
MDCG 2025-7 Rev. 1 - Position Paper: Timelines
of implementation of ‘Master UDI-DI’ to CL, SF
and RTW reading spectacles published
The Commission has published the MDCG 2025-7 Rev.1 Position Paper: Timelines of the implementation
of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading
spectacles on its website.
The changes brought by this revision are mentioned page 2, the most important being the update of the
date of applicability of Commission Delegated Regulation (EU) 2025/1920.
MDCG 2025–10
Guidance on post-market surveillance of medical
devices and in vitro diagnostic medical devices
published
The MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic
medical devices has been published on Commission website.
Scope and Objectives of this guidance
Unless otherwise stated, this guidance is applicable to all medical devices (MDs) and in vitro diagnostic
medical devices (IVDs).
The main objectives of this guidance are:
1. To describe the PMS system.
2. To describe the PMS plan.
3. To describe the main activities within the PMS system.
4. To clarify the interactions of the PMS system in accordance with Article 83 MDR/Article 78 IVDR with
other key aspects of the QMS as described in Article 10(9) MDR and Article 10(8) IVDR).
https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216-ExecSum.pdf
https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216-ExecSum.pdf
https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216-ExecSum.pdf
https://health.ec.europa.eu/document/download/ad6ae143-baa2-451a-8c5e-0c5d22983e88_en?filename=mdcg_2025-7_en.pdf
https://health.ec.europa.eu/document/download/ad6ae143-baa2-451a-8c5e-0c5d22983e88_en?filename=mdcg_2025-7_en.pdf
https://health.ec.europa.eu/document/download/ad6ae143-baa2-451a-8c5e-0c5d22983e88_en?filename=mdcg_2025-7_en.pdf
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec18
https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf
https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
AESGP OTC News | January 2026 18 | 23
Out of scope:
• This guidance does not provide details on how a manufacturer should prepare a periodic safety update
report (‘PSUR’) or a post-market surveillance report. Specific guidance on PSUR is provided in MDCG
2022-21. Although not covering post-market surveillance reports, MDCG 2022-21 may provide useful
suggestions on how a manufacturer can present information in a post-market surveillance report.
• This guidance does not cover the requirements for health institution exemption under Article 5(5)
MDR/IVDR (in-house devices), though it is expected that health institutions review experience gained from
the use of in-house devices and take all necessary corrective actions.
Health Technology Assessment
New Opportunity to Apply for Joint Scientific
Consultations
The Commission has opened the first submission period for joint scientific consultations (JSCs) for 2026.
This is the third submission period under the EU Health Technology Assessment Regulation, after its entry
into application on 12 January 2025. Two submission periods were concluded last year with a total of
seven JSCs selected, of which four are already finalised.
JSCs enable health technology developers (pharma and medtech companies) to consult with the Health
Technology Assessment agencies in the Member States on how their clinical studies should be conducted
to best prepare for a potential Joint Clinical Assessment.
The submission period is open from 7 January to 4 February 2026 to developers of both medicines
and medical devices. There is no fee for this service.
Health technology developers can also request the JSC to be carried out in parallel with the European
Medicines Agency’s (EMA) scientific advice. This means that the meeting with the health technology
developer and the individual experts is a joint meeting with the EMA, their scientific advice coordinators
and their experts.
Developers can apply for the following consultation slots during this request period:
• Briefing document by 07 April 2026
• Briefing document by 04 May 2026
• Briefing document by 08 June 2026
Requests must be uploaded to the HTA IT Platform by 4 February 2026. As access to the platform can
take a few days, early registration is recommended. Submit a request here .
Find out more:
• Health Technology Assessment
• Factsheet: Implementing the EU Health Technology Assessment Regulation
• Factsheet on joint scientific consultations
• Regulation 2021/2282 on Health Technology Assessment
• Joint scientific consultations
• Implementing act on joint scientific consultations on medicinal products
• Implementing act on joint scientific consultations on medical devices and in vitro
diagnostic medical devices
• Guidance documents for joint scientific consultations
https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-scientific-consultations_en
https://health.ec.europa.eu/health-technology-assessment_en
https://health.ec.europa.eu/document/download/84c1ec8f-9be3-4073-aceb-330764c93152_en?filename=hta_regulation-implementation_factsheet_en.pdf
https://health.ec.europa.eu/document/download/3385c0cd-e468-4384-a591-0123c3e6a521_en?filename=hta_htar_factsheet-jsc_en.pdf
https://eur-lex.europa.eu/eli/reg/2021/2282/oj/eng
https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-scientific-consultations_en
https://eur-lex.europa.eu/eli/reg_impl/2024/3169
https://eur-lex.europa.eu/eli/reg_impl/2025/117
https://eur-lex.europa.eu/eli/reg_impl/2025/117
https://health.ec.europa.eu/health-technology-assessment/key-documents_en?f%5B0%5D=topic_topic%3A236
AESGP OTC News | January 2026 19 | 23
MDCG Eudamed WG - Survey on Onboarding
Materials for completion by Mid FEB
Approaching the mandatory use of EUDAMED on 28 MAY 2026, the Commission is expanding the
resources and documentation to facilitate the EUDAMED onboarding.
To ensure a seamless transition and optimal use of the system, the Commission is kindly inviting you to
complete this Onboarding Survey by mid-February. Your answers will help to improve the onboarding
materials and documentation.
The Survey is also accessible via the Production EUDAMED Information Centre – Onboarding Material
section.
https://ec.europa.eu/eusurvey/runner/68bc98d4-aad1-f53a-5736-1739141ff3d3
https://webgate.ec.europa.eu/eudamed-help/en/onboarding-material.html
https://webgate.ec.europa.eu/eudamed-help/en/onboarding-material.html
AESGP OTC News | January 2026 20 | 23
Reflection paper on product environmental scoring -
Member feedback requested - 5 FEB 2026
Following an earlier action point agreed in the ENVICOM meeting in September 2025, we would like to
invite your feedback on the reflection paper on product environmental scoring initiatives.
The link to the reflection paper is stated below and comment in track changes.
• Draft reflection paper on product environmental scoring initiatives.docx
The reflection paper is mainly based on the previous ENVICOM slides, discussions, and minutes, as well
as public information available on the topic from the EU institutions and corporate websites.
It is intended as an internal document for reflection and discussion among AESGP members, while
compiling ongoing developments, associated risks, and opportunities related to product environmental
scoring initiatives and supporting shared understanding at this stage.
It is not a formal AESGP position, nor intended to be circulated or published externally.
Comments regarding the below points would be appreciated:
• The accuracy and completeness of the analysis.
• The framing of risks and opportunities for the self-care sector.
Any key points that may merit further reflection or clarification.
Microplastics reporting under Commission Regulation
2023/2055 - Draft amendment to Annex XVII, entry 78
The European Commission has published a draft amendment to REACH Microplastics Restriction
(Annex XVII, entry 78), clarifying and correcting specific points in the existing text. The most notable
corrections are:
• Introduction of explicit derogations for medicinal products (including clinical trials and pre-clinical
testing)
• New derogation for PPORD uses ≤1 tonne/year (including R&D outside industrial sites e.g.,
universities and hospitals)
• Stricter interpretation of the ‘permanently incorporated in a solid matrix’ exemption (now limited
to end uses lasting ≥1 year, with 2-year transition).
Medicinal product and PPORD clarifications apply retroactively from 17 October 2023, correcting
unintended non-compliance.
Environment
https://aesgpbrussels-my.sharepoint.com/:w:/g/personal/v_virtanen_aesgp_eu/IQDXbwlclavXT4uqCGD5RZahARn0skIzf4qNDuWfLMPR2co
https://data.consilium.europa.eu/doc/document/ST-5163-2026-ADD-1/en/pdf
AESGP OTC News | January 2026 21 | 23
General Pharmaceutical Legislation Revision - EP and
Council reach trilogue agreement
On 11 December 2025, the European Parliament and Council reached a provisional agreement on
the revision of the General Pharmaceutical Legislation. The Press Releases by the Council,the
Parliament and the Commission are available.
The Council and the European Parliament have reached an agreement on the ‘pharma package’, a new
set of rules that will increase patients' access to medicine and make the EU’s pharmaceutical sector fairer
and more competitive.
The package represents a far-reaching reform of the EU’s pharmaceutical legislation and will help
ensure fair access to safe, effective and affordable medicines across the EU.
It also seeks to boost the competitiveness of the pharmaceutical industry by cutting regulatory
burdens and strengthening security of supply to prevent and manage shortages.
The final text is expected to be released in February (it’s undergoing technical review). Please note
that the text will then still need to proceed through the formal adoption process by both co-
legislator (European Parliament and Council) before it is published in the Official Journal.
In a Background Note to the SANT Committee some of the items have been detailed, however these are
still “subject to revision of texts following the provisional agreement, legal checks and final
adoption”.
Biotech Act - European Commission publishes a
legislative proposal
The European Commission published a proposal for a REGULATION OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening
Union’s biotechnology and biomanufacturing sectors particularly in the area of health and
amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU)
2024/795 and (EU) 2024/1938 (European Biotech Act). The dedicated Commission press release
and Q&As are available.
The Biotech Act proposes to amend specific parts of EU health and food regulations, to adapt the
whole ecosystem to the needs of modern society and this fast-growing sector. The proposals include
revising EU rules on clinical trials, advanced therapy medicinal products, substances of human origin,
veterinary medicinal products, general food law, human organs and genetically modified organisms.
Changes to General Food Law (Regulation (EC) No 178/2002)
The Biotech Act proposes amendments to Regulation (EC) No 178/2002 (General Food Law) laying
down the general principles and requirements of food law.
Cross-Sectorial
News
https://www.consilium.europa.eu/en/press/press-releases/2025/12/11/pharma-package-council-and-parliament-reach-a-deal-on-new-rules-for-a-fairer-and-more-competitive-eu-pharmaceutical-sector/
https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3015
https://www.europarl.europa.eu/news/en/press-room/20251209IPR32111/background-note-pharmaceutical-package-provisional-agreement-elements
https://health.ec.europa.eu/document/download/ec1475b7-e3f9-409e-b927-fc7e69306a8c_en?filename=biotech_reg-com2025-1022_act_en.pdf
https://health.ec.europa.eu/document/download/ec1475b7-e3f9-409e-b927-fc7e69306a8c_en?filename=biotech_reg-com2025-1022_act_en.pdf
https://health.ec.europa.eu/document/download/ec1475b7-e3f9-409e-b927-fc7e69306a8c_en?filename=biotech_reg-com2025-1022_act_en.pdf
https://health.ec.europa.eu/document/download/ec1475b7-e3f9-409e-b927-fc7e69306a8c_en?filename=biotech_reg-com2025-1022_act_en.pdf
https://health.ec.europa.eu/document/download/ec1475b7-e3f9-409e-b927-fc7e69306a8c_en?filename=biotech_reg-com2025-1022_act_en.pdf
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
https://ec.europa.eu/commission/presscorner/detail/en/qanda_25_3079
AESGP OTC News | January 2026 22 | 23
• The Act broadens the scope of pre-submission advice provided by the European Food Safety
Authority (EFSA) to study design, and reforms the EFSA Panel system to speed up risk assessment
procedures.
• Provisions for regulatory sandboxes are introduced, allowing Member States to test innovative
technologies under harmonised conditions that foster innovation while safeguarding consumer health
and safety
Industrial policy measures and simplification
The proposal also places strong emphasis on industrial competitiveness and regulatory simplification. Key
elements include:
• Improved access to funding to support growth and scale-up of EU biotech companies, including a
health biotech pilot (2026–2027) in cooperation with the EIB Group, mobilising up to €10 billion
• Strengthening EU industrial and innovation capacity, including centres of excellence for advanced
therapy medicinal products, biomanufacturing testing and training environments, data quality
accelerators, and biodefence projects
• Targeted extensions of patent protection for key EU innovations in health and veterinary
biotechnology, alongside support for strategic areas such as biosimilars
• Greater use of AI, data, and digital solutions, including implementation of the European Health Data
Space, trusted AI testing environments, and support for SMEs, start-ups, and scale-ups
• Further simplification and acceleration of regulatory procedures to reduce time-to-market,
including harmonised requirements and expanded use of regulatory sandboxes
• Enhanced biosecurity safeguards to prevent misuse of biotechnology and strengthen EU
biodefence capabilities
AESGP — Association of the
European Self-Care Industry
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1040 Brussels Belgium
info@aesgp.eu
www.aesgp.eu
07.04.2026
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