| 12/09/2024 | Document: PRIME eligibility requests: 2025 deadlines for submission and timetable for assessment | New |
| 12/09/2024 | PSUSA: PSUSA-00001276-202312 - periodic safety update report single assessment | New |
| 12/09/2024 | Medicine: Evrysdi | Updated |
| 12/09/2024 | PSUSA: PSUSA/00001169/232312 - periodic safety update report single assessment | New |
| 12/09/2024 | Medicine: Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan) | Updated |
| 12/09/2024 | Medicine: Xarelto | Updated |
| 12/09/2024 | Medicine: Rozlytrek | Updated |
| 12/09/2024 | Document: Agenda of the Medicine Shortages SPOC Working Party meeting - 11 September 2024 | New |
| 11/09/2024 | Medicine: Nilotinib Accord | Updated |
| 11/09/2024 | Medicine: Steqeyma | Updated |
| 11/09/2024 | Medicine: Fingolimod Accord | Updated |
| 11/09/2024 | Medicine: Ritonavir Viatris (previously Ritonavir Mylan) | Updated |
| 11/09/2024 | Medicine: Ibandronic acid Accord | Updated |
| 11/09/2024 | Medicine: Cresemba | Updated |
| 11/09/2024 | Document: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) | Updated |
| 11/09/2024 | Event: Information session on the pilot for expert panels' advice for orphan medical devices | Updated |
| 11/09/2024 | Document: Agenda - Information session on the pilot for expert panels' advice for orphan medical devices | New |
| 11/09/2024 | Document: Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP | Updated |
| 11/09/2024 | Document: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs) | Updated |
| 11/09/2024 | Page: Questions and answers on the guideline on the environmental risk assessment of medicinal products for human use | Updated |
| 11/09/2024 | Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP | Updated |
| 11/09/2024 | Event: Union Product Database webinar for veterinary marketing authorisation holders on an industry-dedicated read API | New |
| 11/09/2024 | Medicine: Tadalafil Lilly | Updated |
| 11/09/2024 | Page: Questions and answers regarding co-processed excipients used in solid oral dosage forms | New |
| 11/09/2024 | Document: Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V) | New |
| 11/09/2024 | Medicine: Cialis | Updated |
| 11/09/2024 | Medicine: Talzenna | Updated |
| 11/09/2024 | Medicine: Pregabalin Viatris (previously Pregabalin Mylan) | Updated |
| 10/09/2024 | Document: EMA guidance on the use of medicinal products for treatment and prophylaxis in case of exposure to biological agents used as weapons of terrorism, crime or warfare | Updated |
| 10/09/2024 | Document: EMA guidance on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfare | Updated |
| 10/09/2024 | Page: Haematology Working Party | Updated |
| 10/09/2024 | Document: Consolidated 3-year rolling work plan for the Haematology Working Party (HAEMWP) : January 2025 - December 2027 | New |
| 10/09/2024 | Page: Oncology Working Party | Updated |
| 10/09/2024 | Document: Consolidated 3-year rolling work plan for the Oncology Working Party : January 2025 - December 2027 | New |
| 10/09/2024 | Page: Rheumatology/Immunology Working Party | Updated |
| 10/09/2024 | Document: Draft 3-year rolling work plan for the Rheumatology and Immunology Working Party (RIWP) : 2025-2027 | New |
| 10/09/2024 | Document: CAT quarterly highlights and approved ATMPs - May-July 2024 | New |
| 10/09/2024 | Page: Procurement | Updated |
| 10/09/2024 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 July 2024 | Updated |
| 10/09/2024 | Document: Minutes of the PRAC meeting 8-11 July 2024 | New |
| 10/09/2024 | Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOm | Updated |
| 10/09/2024 | Medicine: Nobilis Multriva RT+IBm+ND+EDS | Updated |
| 10/09/2024 | PSUSA: PSUSA/00001910/202312 - periodic safety update report single assessment | New |
| 10/09/2024 | PSUSA: PSUSA/00003047/202312 - periodic safety update report single assessment | New |
| 10/09/2024 | PSUSA: PSUSA/00001813/202310 - periodic safety update report single assessment | New |
| 10/09/2024 | PSUSA: PSUSA/00001351/202309 - periodic safety update report single assessment | New |
| 10/09/2024 | PSUSA: PSUSA/00000277/202312 - periodic safety update report single assessment | New |
| 10/09/2024 | Medicine: Prometax | Updated |
| 10/09/2024 | EU-M4all: Fexinidazole Winthrop | Updated |
| 10/09/2024 | PSUSA: PSUSA/00002797/202312 - periodic safety update report single assessment | New |
| 10/09/2024 | Medicine: Abrysvo | Updated |
| 10/09/2024 | Medicine: Instanyl | Updated |
| 10/09/2024 | Medicine: Imvanex | Updated |
| 10/09/2024 | Document: CTIS newsflash - 10 September 2024 | New |
| 10/09/2024 | Document: Membership list: HMA-EMA joint Big Data Steering Group | Updated |
| 09/09/2024 | Medicine: Tysabri | Updated |
| 09/09/2024 | Medicine: Olumiant | Updated |
| 09/09/2024 | Medicine: Nyxthracis (previously Obiltoxaximab SFL) | Updated |
| 09/09/2024 | Event: Scientific Symposium on Advanced Therapy Medicinal Products - ‘Contribution, evolution, revolution’ | New |
| 09/09/2024 | Event: Info session on web-based electronic Application Form (eAF) add package | Updated |
| 09/09/2024 | Document: Questions and answers - Info session on web-based electronic Application Form (eAF) add package | New |
| 09/09/2024 | Document: Member states contact points for translations review | Updated |
| 09/09/2024 | Medicine: Lytenava | Updated |
| 09/09/2024 | Document: Agenda of the CVMP meeting 10-12 September 2024 | New |
| 09/09/2024 | Medicine: Tadalafil Mylan | Updated |
| 09/09/2024 | PSUSA: PSUSA/00001662/202401 - periodic safety update report single assessment | New |
| 09/09/2024 | PSUSA: PSUSA/00002487/202401 - periodic safety update report single assessment | New |
| 09/09/2024 | PSUSA: PSUSA/00001596/202401 - periodic safety update report single assessment | New |
| 09/09/2024 | Document: Veterinary pre-submission meeting request form - in accordance with Regulation (EU) No 2019/6 | Updated |
| 09/09/2024 | Event: Committee for Advanced Therapies (CAT): 11-12 September 2024 | Updated |
| 09/09/2024 | Page: Clinical development of medicinal products for the treatment and prevention of bipolar disorder | Updated |
| 09/09/2024 | Document: Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1 | New |
| 06/09/2024 | Page: Scientific publications | Updated |
| 06/09/2024 | Medicine: Zimbus Breezhaler | Updated |
| 06/09/2024 | PSUSA: PSUSA/00001996/202401 - periodic safety update report single assessment | New |
| 06/09/2024 | PSUSA: PSUSA/00000616/202312 - periodic safety update report single assessment | New |
| 06/09/2024 | PSUSA: PSUSA/00002781/202401 - periodic safety update report single assessment | New |
| 06/09/2024 | PSUSA: PSUSA/00009074/202401 - periodic safety update report single assessment | New |
| 06/09/2024 | PSUSA: PSUSA/00002680/202312 - periodic safety update report single assessment | New |
| 06/09/2024 | PSUSA: PSUSA/00000928/202312 - periodic safety update report single assessment | New |
| 06/09/2024 | Document: Applications for new human medicines under evaluation: September 2024 | New |
| 06/09/2024 | Medicine: Rystiggo | Updated |
| 06/09/2024 | Medicine: Repatha | Updated |
| 06/09/2024 | Herbal: Soiae oleum raffinatum - herbal medicinal product | Updated |
| 06/09/2024 | Herbal: Mastic - herbal medicinal product | Updated |
| 06/09/2024 | Medicine: Aspaveli | Updated |
| 06/09/2024 | Referral: Lorazepam Macure 4 mg/ml, solution for injection - referral | Updated |
| 06/09/2024 | Medicine: Entresto | Updated |
| 06/09/2024 | Medicine: Neparvis | Updated |
| 06/09/2024 | Medicine: Noxafil | Updated |
| 06/09/2024 | Referral: Metamizole-containing medicinal products - referral | Updated |
| 06/09/2024 | Medicine: Savene | Updated |
| 06/09/2024 | Medicine: Ivabradine Accord | Updated |
| 06/09/2024 | Medicine: Paxlovid | Updated |
| 06/09/2024 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024 | New |
| 06/09/2024 | PSUSA: PSUSA/00010710/202401 - periodic safety update report single assessment | New |
| 06/09/2024 | Medicine: Cholestagel | Updated |
| 06/09/2024 | PSUSA: PSUSA/00000850/202312 - periodic safety update report single assessment | New |
| 06/09/2024 | Medicine: mResvia | Updated |
| 05/09/2024 | Medicine: Multaq | Updated |
| 05/09/2024 | Medicine: Camzyos | Updated |
| 05/09/2024 | Medicine: Mektovi | Updated |
| 05/09/2024 | Medicine: Braftovi | Updated |
| 05/09/2024 | Medicine: Viagra | Updated |
| 05/09/2024 | Medicine: Spikevax (previously COVID-19 Vaccine Moderna) | Updated |
| 05/09/2024 | Medicine: Lyxumia | Updated |
| 05/09/2024 | Medicine: Bimervax | Updated |
| 05/09/2024 | Medicine: Nuvaxovid | Updated |
| 05/09/2024 | News: Harnessing AI in medicines regulation: use of large language models (LLMs) | New |
| 05/09/2024 | Page: Artificial intelligence | Updated |
| 05/09/2024 | Document: Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities | New |
| 05/09/2024 | Document: Factsheet - four principles for safe and responsible use of large language models | New |
| 05/09/2024 | Medicine: Eurneffy | Updated |
| 05/09/2024 | Medicine: Dapagliflozin Viatris | Updated |
| 05/09/2024 | Event: Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported by ACT EU | Updated |
| 05/09/2024 | Medicine: Pemetrexed Sandoz | Updated |
| 05/09/2024 | Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) | Updated |
| 05/09/2024 | Medicine: Pregabalin Sandoz | Updated |
| 05/09/2024 | Medicine: Apexelsin | Updated |
| 05/09/2024 | Medicine: Arava | Updated |
| 05/09/2024 | Medicine: Reagila | Updated |
| 05/09/2024 | Medicine: Betmiga | Updated |
| 04/09/2024 | Medicine: Beyfortus | Updated |
| 04/09/2024 | Document: Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status | Updated |
| 04/09/2024 | Document: Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status | Updated |
| 04/09/2024 | Medicine: Infanrix Hexa | Updated |
| 04/09/2024 | Event: Fourth veterinary big data stakeholder forum | Updated |
| 04/09/2024 | Page: Plasma master file certificates | Updated |
| 04/09/2024 | Medicine: Abecma | Updated |
| 04/09/2024 | Medicine: Breyanzi | Updated |
| 04/09/2024 | Medicine: Spravato | Updated |
| 04/09/2024 | Event: Quarterly System Demo – Q3 2024 | Updated |
| 04/09/2024 | Event: EMA multi-stakeholder workshop on qualification of novel methodologies | Updated |
| 04/09/2024 | Medicine: Dovprela (previously Pretomanid FGK) | Updated |
| 04/09/2024 | Referral: Havrix - referral | Updated |
| 04/09/2024 | Medicine: Efient | Updated |
| 04/09/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - November 2024 | New |
| 04/09/2024 | Document: Appendix 1: Acceptable intakes established for N-nitrosamines | Updated |
| 04/09/2024 | Document: Rapid alert notification of a quality defect / recall | Updated |
| 04/09/2024 | Document: Follow-up and non-urgent information for quality defects | Updated |
| 04/09/2024 | Document: Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product | Updated |
| 04/09/2024 | Medicine: Rivastigmine Actavis | Updated |
| 04/09/2024 | Medicine: Xgeva | Updated |
| 04/09/2024 | Medicine: Fabrazyme | Updated |
| 04/09/2024 | Medicine: Tecentriq | Updated |
| 04/09/2024 | Medicine: Pegasys | Updated |
| 03/09/2024 | Medicine: Revinty Ellipta | Updated |
| 03/09/2024 | Event: Clinical Trials Information System (CTIS): Information day | New |
| 03/09/2024 | Medicine: Relvar Ellipta | Updated |
| 03/09/2024 | Medicine: Hizentra | Updated |
| 03/09/2024 | Medicine: Renvela | Updated |
| 03/09/2024 | Page: ICH guideline E11A on pediatric extrapolation - Scientific guideline | Updated |
| 03/09/2024 | Document: ICH guideline E11A on pediatric extrapolation Step 5 | Updated |
| 03/09/2024 | Medicine: Renagel | Updated |
| 03/09/2024 | Medicine: Carmustine medac (previously Carmustine Obvius) | Updated |
| 03/09/2024 | Medicine: Phesgo | Updated |
| 03/09/2024 | Medicine: Jevtana | Updated |
| 03/09/2024 | Medicine: Venclyxto | Updated |
| 03/09/2024 | Medicine: Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) | Updated |
| 03/09/2024 | Document: Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling | Updated |
| 03/09/2024 | PSUSA: PSUSA/00000262/202311 - periodic safety update report single assessment | New |
| 02/09/2024 | Medicine: Pramipexole Teva | Updated |
| 02/09/2024 | Medicine: Tafinlar | Updated |
| 02/09/2024 | DHPC: Ozempic / Victoza - direct healthcare professional communication (DHPC) | New |
| 02/09/2024 | Event: Paediatric Committee (PDCO): 3-6 September 2024 | Updated |
| 02/09/2024 | Document: Agenda - PDCO agenda of the 3-6 September 2024 meeting | New |
| 02/09/2024 | Event: Paediatric Committee (PDCO): 25-28 June 2024 | Updated |
| 02/09/2024 | Document: PDCO minutes of the 25-28 June 2024 meeting | New |
| 02/09/2024 | Document: Agenda of the PRAC meeting 2-5 September 2024 | New |
| 02/09/2024 | Medicine: Lynparza | Updated |
| 02/09/2024 | Medicine: Toujeo (previously Optisulin) | Updated |
| 02/09/2024 | Document: Amoxicillin and amoxicillin/clavulanic acid supply shortage | Updated |
| 02/09/2024 | Document: European Medicines Agency’s data protection notice for EudraVigilance Human (EV) | Updated |
| 02/09/2024 | Medicine: Jylamvo | Updated |
| 02/09/2024 | Medicine: Vabysmo | Updated |
| 02/09/2024 | Medicine: Imfinzi | Updated |
| 02/09/2024 | Medicine: Lantus | Updated |
| 02/09/2024 | Medicine: Olanzapine Teva | Updated |
| 02/09/2024 | PSUSA: PSUSA/00001529/202311 - periodic safety update report single assessment | New |
