| 27/03/2024 | Event: Quarterly System Demo Q1 2024 | Updated |
| 27/03/2024 | Medicine: Cotellic | Updated |
| 27/03/2024 | Medicine: Kisqali | Updated |
| 27/03/2024 | Medicine: Fintepla | Updated |
| 27/03/2024 | Page: Pre-authorisation guidance | Updated |
| 27/03/2024 | Page: Fees payable to the European Medicines Agency | Updated |
| 27/03/2024 | News: Regulatory information – adjusted fees for applications to EMA from 1 April 2024 | New |
| 27/03/2024 | Document: Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human | Updated |
| 27/03/2024 | Page: Extensions of marketing authorisations: questions and answers | Updated |
| 27/03/2024 | Page: Type-II variations: questions and answers | Updated |
| 27/03/2024 | Medicine: Emgality | Updated |
| 27/03/2024 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes | Updated |
| 27/03/2024 | Medicine: Arixtra | Updated |
| 27/03/2024 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure | Updated |
| 27/03/2024 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | Updated |
| 27/03/2024 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes | Updated |
| 27/03/2024 | Medicine: Gardasil | Updated |
| 27/03/2024 | Page: Post-authorisation safety studies (PASS) | Updated |
| 27/03/2024 | Page: Type-IA variations: questions and answers | Updated |
| 27/03/2024 | Medicine: Zelboraf | Updated |
| 27/03/2024 | Document: Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections | Updated |
| 26/03/2024 | Medicine: Jcovden (previously COVID-19 Vaccine Janssen) | Updated |
| 26/03/2024 | Document: HMPC: overview of assessment work - priority list | Updated |
| 26/03/2024 | PSUSA: PSUSA/00001057/202303 - periodic safety update report single assessment | New |
| 26/03/2024 | Medicine: Zolgensma | Updated |
| 26/03/2024 | Medicine: Pravafenix | Updated |
| 26/03/2024 | Medicine: Karvezide | Updated |
| 26/03/2024 | Medicine: CoAprovel | Updated |
| 26/03/2024 | Event: Committee for Herbal Medicinal Products (HMPC): 29-31 January 2024 | Updated |
| 26/03/2024 | Event: Management Board meeting: 21 March 2024 | Updated |
| 26/03/2024 | Medicine: Ximluci | Updated |
| 26/03/2024 | Medicine: Clopidogrel ratiopharm | Updated |
| 26/03/2024 | Medicine: Rystiggo | Updated |
| 26/03/2024 | Medicine: Upstaza | Updated |
| 26/03/2024 | Medicine: Livtencity | Updated |
| 26/03/2024 | News: EMA business hours over Easter holiday period | New |
| 26/03/2024 | Medicine: Cuprior | Updated |
| 26/03/2024 | Document: Appendix 3 : Enhanced Ames Test Conditions for N-nitrosamines | Updated |
| 26/03/2024 | News: EU recommendations for 2024/2025 seasonal flu vaccine composition | New |
| 26/03/2024 | Medicine: Myalepta | Updated |
| 26/03/2024 | Page: Medical literature monitoring | Updated |
| 25/03/2024 | Document: Functionalities in support of the medical literature monitoring service User manual: EudraVigilance ICSR Downloads and tracking spreadsheets | Updated |
| 25/03/2024 | Document: Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - MEDLINE | Updated |
| 25/03/2024 | Document: Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - EMBASE | Updated |
| 25/03/2024 | Document: Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Description of the Journal/Reference databases used | Updated |
| 25/03/2024 | PSUSA: PSUSA/00010378/202305 - periodic safety update report single assessment | New |
| 25/03/2024 | PSUSA: PSUSA/00001362/202307 - periodic safety update report single assessment | New |
| 25/03/2024 | PSUSA: PSUSA/00000905/202307 - periodic safety update report single assessment | New |
| 25/03/2024 | PSUSA: PSUSA/00001826/202305 - periodic safety update report single assessment | New |
| 25/03/2024 | PSUSA: PSUSA/00010441/202304 - periodic safety update report single assessment | New |
| 25/03/2024 | Document: FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation | Updated |
| 25/03/2024 | Page: Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Scientific guideline | Updated |
| 25/03/2024 | Medicine: Tecentriq | Updated |
| 25/03/2024 | Medicine: Tysabri | Updated |
| 25/03/2024 | Medicine: Vimpat | Updated |
| 22/03/2024 | Event: Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 February 2024 | Updated |
| 22/03/2024 | Medicine: Exblifep | Updated |
| 22/03/2024 | Page: Health technology assessment bodies | Updated |
| 22/03/2024 | News: EMA Management Board: highlights of March 2024 meeting | New |
| 22/03/2024 | PIP: EMEA-000524-PIP01-08 - paediatric investigation plan | Updated |
| 22/03/2024 | Document: Stakeholder engagement highlights 2022 | Updated |
| 22/03/2024 | Medicine: Vocabria | Updated |
| 22/03/2024 | Medicine: Rayvow | Updated |
| 22/03/2024 | Document: Scientific Explorer - Frequently Asked Questions | New |
| 22/03/2024 | Document: CTIS newsflash - 22 March 2024 | New |
| 22/03/2024 | Medicine: Mektovi | Updated |
| 22/03/2024 | Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient - referral | Updated |
| 22/03/2024 | Medicine: Fabhalta | New |
| 22/03/2024 | Referral: Micrazym and associated names - referral | New |
| 22/03/2024 | Post-authorisation: Ongentys - withdrawal of application for variation to marketing authorisation | New |
| 22/03/2024 | Medicine: Omlyclo | New |
| 22/03/2024 | Medicine: Dimethyl fumarate Accord | New |
| 22/03/2024 | Post-authorisation: Nilemdo - opinion on variation to marketing authorisation | New |
| 22/03/2024 | Medicine: Awiqli | New |
| 22/03/2024 | Medicine: Lytenava | New |
| 22/03/2024 | Medicine: Dimethyl fumarate Mylan | New |
| 22/03/2024 | Medicine: Jubbonti | New |
| 22/03/2024 | Medicine: Wyost | New |
| 22/03/2024 | Medicine: Dimethyl fumarate Neuraxpharm | New |
| 22/03/2024 | Medicine: Neoatricon | New |
| 22/03/2024 | Post-authorisation: Nustendi - opinion on variation to marketing authorisation | New |
| 22/03/2024 | Post-authorisation: Onivyde pegylated liposomal (previously known as Onivyde) - opinion on variation to marketing authorisation | New |
| 22/03/2024 | Post-authorisation: Adcetris - withdrawal of application for variation to marketing authorisation | New |
| 22/03/2024 | Post-authorisation: Retsevmo - opinion on variation to marketing authorisation | New |
| 22/03/2024 | Medicine: Agilus | New |
| 22/03/2024 | News: New antibiotic to fight infections caused by multidrug-resistant bacteria | New |
| 22/03/2024 | News: First oral monotherapy for patients with paroxysmal nocturnal haemoglobinuria | New |
| 22/03/2024 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024 | New |
| 22/03/2024 | Document: CHMP post-authorisation summary of positive opinion for Nustendi (II-35) | New |
| 22/03/2024 | Document: CHMP summary of positive opinion for Fabhalta | New |
| 22/03/2024 | Referral: Havrix - referral | Updated |
| 22/03/2024 | Medicine: Zoledronic acid Mylan | Updated |
| 21/03/2024 | Page: Environmental risk assessment of medicinal products for human use - Scientific guideline | Updated |
| 21/03/2024 | Event: Product Management Services (PMS) deep-dive webinar | Updated |
| 21/03/2024 | Medicine: Mekinist | Updated |
| 21/03/2024 | Medicine: Casgevy | Updated |
| 21/03/2024 | Medicine: Yervoy | Updated |
| 21/03/2024 | Event: Technical Webinar: Regulatory Procedure Management for PLM in IRIS for Network Users | Updated |
| 21/03/2024 | Medicine: Vabysmo | Updated |
| 21/03/2024 | Medicine: Faslodex | Updated |
| 21/03/2024 | PSUSA: PSUSA/00010354/202305 - periodic safety update report single assessment | New |
| 21/03/2024 | Document: Agenda of the 123rd meeting of the Management Board : 21 March 2024 | New |
| 21/03/2024 | Medicine: Kineret | Updated |
| 21/03/2024 | DHPC: Paxlovid - direct healthcare professional communication (DHPC) | New |
| 21/03/2024 | Document: Template for pharmacovigilance assessment information sharing | Updated |
| 21/03/2024 | Medicine: Neparvis | Updated |
| 21/03/2024 | Medicine: Dapagliflozin Viatris | Updated |
| 21/03/2024 | Medicine: Libmyris | Updated |
| 21/03/2024 | Event: Eleventh industry stakeholder platform on research and development support | Updated |
| 20/03/2024 | Document: Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD) | Updated |
| 20/03/2024 | Document: Article 57 product data | Updated |
| 20/03/2024 | Medicine: Tagrisso | Updated |
| 20/03/2024 | Event: European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FVE) info session on the UPD public portal | Updated |
| 20/03/2024 | Medicine: Esbriet | Updated |
| 20/03/2024 | Medicine: SomaKit TOC | Updated |
| 20/03/2024 | Document: EVVet3 EVWeb Production – Release notes | Updated |
| 20/03/2024 | Medicine: RoActemra | Updated |
| 20/03/2024 | Medicine: Zeffix | Updated |
| 20/03/2024 | Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting | New |
| 20/03/2024 | Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting | New |
| 20/03/2024 | Medicine: Nexium Control | Updated |
| 20/03/2024 | Event: Electronic Common Technical Document (eCTD) vendor workshop | New |
| 20/03/2024 | Medicine: VidPrevtyn Beta | Updated |
| 20/03/2024 | Document: Agenda - PDCO agenda of the 19-22 March 2024 meeting | New |
| 20/03/2024 | News: Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU | New |
| 20/03/2024 | Medicine: Lutathera | Updated |
| 20/03/2024 | Medicine: Eylea | Updated |
| 20/03/2024 | Medicine: Blincyto | Updated |
| 20/03/2024 | Medicine: Abrysvo | Updated |
| 20/03/2024 | Medicine: Kymriah | Updated |
| 20/03/2024 | Medicine: Cinacalcet Mylan | Updated |
| 20/03/2024 | Medicine: Pradaxa | Updated |
| 19/03/2024 | Medicine: Kesimpta | Updated |
| 19/03/2024 | Medicine: Tecfidera | Updated |
| 19/03/2024 | Medicine: Thalidomide BMS (previously Thalidomide Celgene) | Updated |
| 19/03/2024 | Medicine: Leflunomide medac | Updated |
| 19/03/2024 | Document: DARWIN EU data partners onboarded in phases I and II | Updated |
| 19/03/2024 | Document: Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 1 | New |
| 19/03/2024 | Event: Third listen-and-learn focus group meeting of the Quality Innovation Group | New |
| 19/03/2024 | Medicine: Pepaxti | Updated |
| 18/03/2024 | Page: Transferring a veterinary marketing authorisation | Updated |
| 18/03/2024 | Page: EudraVigilance system overview | Updated |
| 18/03/2024 | Document: Template - Application for transfer of marketing authorisation from transferor to transferee, attachment 2 | New |
| 18/03/2024 | Event: Orphan medicines development - ask the European regulator | Updated |
| 18/03/2024 | Medicine: Pregabalin Zentiva | Updated |
| 18/03/2024 | Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS | New |
| 18/03/2024 | Medicine: Trilocur | New |
| 18/03/2024 | Medicine: Divence Tetra | New |
| 18/03/2024 | Medicine: Lotimax | New |
| 18/03/2024 | Medicine: Trilorale | New |
| 18/03/2024 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-13 March 2024 | New |
| 18/03/2024 | Post-authorisation: Prevexxion RN+HVT+IBD - opinion on variation to marketing authorisation | New |
| 18/03/2024 | Medicine: Epysqli | Updated |
| 18/03/2024 | Page: Union Product Database: release notes | Updated |
| 18/03/2024 | Document: Agenda of the CHMP meeting 18-21 March 2024 | New |
| 15/03/2024 | Medicine: Bosulif | Updated |
| 15/03/2024 | Medicine: Phelinun | Updated |
| 15/03/2024 | Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting | Updated |
| 15/03/2024 | Medicine: Accofil | Updated |
| 15/03/2024 | Medicine: Skyrizi | Updated |
| 15/03/2024 | PSUSA: PSUSA/00002060/202305 - periodic safety update report single assessment | New |
| 14/03/2024 | Page: Industry annual bilateral meetings | Updated |
| 14/03/2024 | Event: Third European Medicines Agency (EMA) and MedTech Europe bilateral meeting | Updated |
| 14/03/2024 | Page: Union Product Database | Updated |
| 14/03/2024 | Medicine: Lacosamide Adroiq | Updated |
| 14/03/2024 | Document: New Organization First User QPPV/RP or Change of EU QPPV/RP | Updated |
| 14/03/2024 | Medicine: Methylthioninium chloride Proveblue | Updated |
| 14/03/2024 | Document: EudraVigilance registration documents | Updated |
| 14/03/2024 | Document: EudraVigilance registration manual | Updated |
| 14/03/2024 | Medicine: Paxlovid | Updated |
| 14/03/2024 | Medicine: Talvey | Updated |
| 14/03/2024 | Document: Record of data processing activity relating to personal files (public) | Updated |
| 14/03/2024 | Event: EMA Veterinary Medicines Info Day 2024 | Updated |
| 14/03/2024 | Medicine: Vijoice | Updated |
| 14/03/2024 | PSUSA: PSUSA/00010271/202307 - periodic safety update report single assessment | New |
| 14/03/2024 | Medicine: Retsevmo | Updated |
| 14/03/2024 | Medicine: Sustiva | Updated |
| 13/03/2024 | PIP: EMEA-001214-PIP07-21 - paediatric investigation plan | New |
| 13/03/2024 | Document: Member states contact points for translations review | Updated |
| 13/03/2024 | PIP: EMEA-001214-PIP04-19 - paediatric investigation plan | New |
| 13/03/2024 | PIP: EMEA-002229-PIP02-21 - paediatric investigation plan | New |
| 13/03/2024 | Page: Eligible patients and consumers organisations | Updated |
| 13/03/2024 | PIP: EMEA-002239-PIP02-21 - paediatric investigation plan | New |
| 13/03/2024 | PIP: EMEA-001196-PIP03-21 - paediatric investigation plan | New |
| 13/03/2024 | Medicine: Imjudo | Updated |
| 13/03/2024 | PIP: EMEA-002431-PIP02-21 - paediatric investigation plan | New |
| 13/03/2024 | Page: Proline - Scientific guideline | Updated |
| 13/03/2024 | Page: Supporting innovation | Updated |
| 13/03/2024 | PIP: EMEA-002839-PIP01-20-M01 - paediatric investigation plan | Updated |
| 13/03/2024 | PIP: EMEA-002700-PIP01-19-M01 - paediatric investigation plan | Updated |
| 13/03/2024 | Event: EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions? | Updated |
| 13/03/2024 | Medicine: Blenrep | Updated |
| 13/03/2024 | Medicine: Ilaris | Updated |
| 13/03/2024 | Document: Blenrep : EPAR - Public assessment report | Updated |
| 13/03/2024 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 13/03/2024 | Medicine: Krazati | Updated |
| 13/03/2024 | Document: Innovation Task Force (ITF) briefing meeting request form | Updated |
| 13/03/2024 | Event: Paediatric Committee (PDCO): 16-19 January 2024 | Updated |
| 13/03/2024 | Orphan: EU/3/05/314 - orphan designation for treatment of tuberculosis | Updated |
| 13/03/2024 | Medicine: Sirturo | Updated |
| 12/03/2024 | Event: Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reporting | Updated |
| 12/03/2024 | Medicine: Pomalidomide Viatris | Updated |
| 12/03/2024 | PSUSA: PSUSA/00000906/202305 - periodic safety update report single assessment | New |
| 12/03/2024 | PSUSA: PSUSA/00010913/202306 - periodic safety update report single assessment | New |
| 12/03/2024 | Medicine: Striascan | Updated |
| 12/03/2024 | Page: Coordination of pharmacovigilance inspections | Updated |
| 12/03/2024 | Document: Applications for new human medicines under evaluation: March 2024 | New |
| 12/03/2024 | Document: DARWIN EU Advisory Board: Membership | Updated |
| 12/03/2024 | Medicine: Ibuprofen Gen.Orph | Updated |
| 12/03/2024 | Medicine: Evkeeza | Updated |
| 12/03/2024 | Medicine: Daxas | Updated |
| 12/03/2024 | Medicine: Verzenios | Updated |
| 12/03/2024 | Medicine: Idefirix | Updated |
| 11/03/2024 | Medicine: Pramipexole Accord | Updated |
| 11/03/2024 | Medicine: Innovax-ILT-IBD | New |
| 11/03/2024 | Medicine: Prevexxion RN+HVT | New |
| 11/03/2024 | Medicine: Eurican L4 | New |
| 11/03/2024 | Medicine: Xultophy | Updated |
| 11/03/2024 | Medicine: Nexviadyme | Updated |
| 11/03/2024 | Medicine: YURVAC RHD | New |
| 11/03/2024 | Medicine: Comirnaty | Updated |
| 11/03/2024 | Herbal: Symphyti radix - herbal medicinal product | Updated |
| 11/03/2024 | Document: Agenda of the COMP meeting 12-14 March 2024 | New |
| 11/03/2024 | Event: Committee for Medicinal Products for Human Use (CHMP): 22-25 January 2024 | Updated |
| 11/03/2024 | Page: Product-specific bioequivalence guidance | Updated |
| 11/03/2024 | Document: Minutes of the CHMP meeting 22-25 January 2024 | New |
| 11/03/2024 | Document: Procedural advice for orphan medicinal product designation: Guidance for sponsors | Updated |
| 11/03/2024 | Document: Fludarabine supply shortage | New |
| 08/03/2024 | PSUSA: PSUSA/00010007/202307 - periodic safety update report single assessment | New |
| 08/03/2024 | PIP: EMEA-001397-PIP04-17-M01 - paediatric investigation plan | Updated |
| 08/03/2024 | PIP: EMEA-001312-PIP02-19 - paediatric investigation plan | Updated |
| 08/03/2024 | PIP: EMEA-001312-PIP03-19 - paediatric investigation plan | Updated |
| 08/03/2024 | PSUSA: PSUSA/00001738/202307 - periodic safety update report single assessment | New |
| 08/03/2024 | Medicine: Zalasta | Updated |
| 08/03/2024 | Medicine: Kinpeygo | Updated |
| 08/03/2024 | Medicine: Skyclarys | Updated |
| 08/03/2024 | Medicine: Eliquis | Updated |
| 08/03/2024 | Medicine: Ivemend | Updated |
| 08/03/2024 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024 | New |
| 08/03/2024 | Medicine: Quofenix | Updated |
| 08/03/2024 | Medicine: HyQvia | Updated |
| 08/03/2024 | Page: Liposomal amphotericin B product-specific bioequivalence guidance | Updated |
| 08/03/2024 | Document: Note on the HORIZON-JU-IHI-2024-06-two-stage funding call: Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence | New |
| 07/03/2024 | Page: Scientific and technical recommendations: Veterinary Medicines Regulation | Updated |
| 07/03/2024 | Document: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance | Updated |
| 07/03/2024 | Document: EudraVigilance Form A | Updated |
| 07/03/2024 | Document: Connection template - EMA ESTRI Gateway using an AS2 compatible product | Updated |
| 07/03/2024 | Document: Connecting to the Agency ESTRI Gateway using an AS2 compatible product | Updated |
| 07/03/2024 | Document: Vendor registration in the EudraVigilance external compliance testing environment (XCOMP) - Registration procedure | Updated |
| 07/03/2024 | Page: Vaccine Monitoring Platform | Updated |
| 07/03/2024 | Document: EudraVigilance - EVWEB user manual | Updated |
| 07/03/2024 | Document: EudraVigilance support guide | Updated |
| 07/03/2024 | PSUSA: PSUSA/00002151/202308 - periodic safety update report single assessment | New |
| 07/03/2024 | PSUSA: PSUSA/00011039/202307 - periodic safety update report single assessment | New |
| 07/03/2024 | PSUSA: PSUSA/00000210/202308 - periodic safety update report single assessment | New |
| 07/03/2024 | Medicine: Imbruvica | Updated |
| 07/03/2024 | PIP: EMEA-002440-PIP01-18-M04 - paediatric investigation plan | Updated |
| 07/03/2024 | Document: Vaccine Monitoring Platform: List of EMA-funded studies | New |
| 07/03/2024 | Event: Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies | Updated |
| 07/03/2024 | PIP: EMEA-002435-PIP01-18-M03 - paediatric investigation plan | Updated |
| 07/03/2024 | PIP: EMEA-002298-PIP01-17-M05 - paediatric investigation plan | Updated |
| 07/03/2024 | Document: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2024-2025 | Updated |
| 07/03/2024 | Medicine: Tafinlar | Updated |
| 07/03/2024 | Document: Meeting Report of the second Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG) | New |
| 07/03/2024 | Document: Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 30 January 2024 | New |
| 07/03/2024 | Event: 3Rs Working Party (3RsWP) plenary meeting – Public session on the 2024 work plan | Updated |
| 07/03/2024 | PIP: EMEA-003341-PIP01-22 - paediatric investigation plan | New |
| 07/03/2024 | PIP: EMEA-003342-PIP01-22 - paediatric investigation plan | New |
| 07/03/2024 | PIP: EMEA-003340-PIP01-22 - paediatric investigation plan | New |
| 07/03/2024 | Page: Opinions and letters of support on the qualification of novel methodologies for medicine development | Updated |
| 06/03/2024 | Medicine: Mounjaro | Updated |
| 06/03/2024 | Medicine: Apealea | Updated |
| 06/03/2024 | Medicine: Doptelet | Updated |
| 06/03/2024 | Page: Data Analysis and Real World Interrogation Network (DARWIN EU) | Updated |
| 06/03/2024 | Document: DARWIN EU: Making health data count | New |
| 06/03/2024 | News: DARWIN EU® continues expanding its capacity to deliver real-world data studies | New |
| 06/03/2024 | PSUSA: PSUSA/00001504/202304 - periodic safety update report single assessment | New |
| 06/03/2024 | Medicine: Cholib | Updated |
| 06/03/2024 | Document: PRAC recommendations on signals adopted at the 5-8 February 2024 PRAC meeting | New |
| 05/03/2024 | Medicine: Filspari | Updated |
| 05/03/2024 | Medicine: Dynastat | Updated |
| 05/03/2024 | Medicine: VeraSeal | Updated |
| 05/03/2024 | Herbal: Silybi mariani fructus - herbal medicinal product | Updated |
| 05/03/2024 | Document: Minutes of the PRAC meeting 8-11 January 2024 | New |
| 05/03/2024 | Medicine: Enhertu | Updated |
| 05/03/2024 | Page: Templates for assessors | Updated |
| 05/03/2024 | Document: CHMP rapporteurs' assessment report for paediatric studies submitted in accordance with Article 46 | Updated |
| 05/03/2024 | Document: Assessment report for post-authorisation measures (PAMs) | Updated |
| 05/03/2024 | Medicine: Clopidogrel TAD | Updated |
| 05/03/2024 | Medicine: Imcivree | Updated |
| 05/03/2024 | Medicine: Kalydeco | Updated |
| 05/03/2024 | Medicine: Ameluz | Updated |
| 05/03/2024 | Event: Sixth European Medicines Agency (EMA) and EFPIA bilateral meeting | Updated |
| 05/03/2024 | Medicine: Otezla | Updated |
| 05/03/2024 | Document: CHMP PROM minutes for the meeting on 12 February 2024 | New |
| 05/03/2024 | Document: CHMP PROM minutes for the meeting on 15 January 2024 | New |
| 04/03/2024 | Medicine: Aclasta | Updated |
| 04/03/2024 | PSUSA: PSUSA/00001506/202304 - periodic safety update report single assessment | New |
| 04/03/2024 | Document: Agenda of the PRAC meeting 4-7 March 2024 | New |
| 04/03/2024 | Medicine: Zyclara | Updated |
| 04/03/2024 | Event: Eight Nitrosamine Implementation Oversight Group (NIOG) meeting | New |
| 04/03/2024 | Medicine: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) | Updated |
| 04/03/2024 | Page: Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' | Updated |
| 04/03/2024 | Event: Training webinar on the use of Scientific Explorer in scientific advice regulatory procedures | New |
| 04/03/2024 | EU-M4all: Dapivirine Vaginal Ring 25 mg | Updated |
| 04/03/2024 | Medicine: Reblozyl | Updated |
| 04/03/2024 | Herbal: Gentianae radix - herbal medicinal product | Updated |
| 04/03/2024 | Herbal: Calendulae flos - herbal medicinal product | Updated |
| 04/03/2024 | Herbal: Boldi folium - herbal medicinal product | Updated |
| 04/03/2024 | Herbal: Avenae herba - herbal medicinal product | Updated |
| 04/03/2024 | Herbal: Avenae fructus - herbal medicinal product | Updated |
| 01/03/2024 | Herbal: Lupuli flos - herbal medicinal product | Updated |
| 01/03/2024 | Herbal: Lini semen - herbal medicinal product | Updated |
| 01/03/2024 | Herbal: Combination: Thymi herba and Primulae radix - herbal medicinal product | Updated |
| 01/03/2024 | Herbal: Rusci rhizoma - herbal medicinal product | Updated |
| 01/03/2024 | Herbal: Sambuci flos - herbal medicinal product | Updated |
| 01/03/2024 | Document: ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1 | New |
| 01/03/2024 | PSUSA: PSUSA-00002110-202305 - periodic safety update report single assessment | New |
| 01/03/2024 | PSUSA: PSUSA/00000613/202305 - periodic safety update report single assessment | New |
| 01/03/2024 | PSUSA: PSUSA/00001500/202304 - periodic safety update report single assessment | New |
| 01/03/2024 | Medicine: MabThera | Updated |
| 01/03/2024 | Medicine: Rxulti | Updated |
| 01/03/2024 | Medicine: Saxenda | Updated |
| 01/03/2024 | Medicine: Toviaz | Updated |
| 01/03/2024 | Herbal: Foeniculi amari fructus - herbal medicinal product | Updated |
| 01/03/2024 | Herbal: Foeniculi dulcis fructus - herbal medicinal product | Updated |
| 01/03/2024 | Document: QRD Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page) | Updated |
| 01/03/2024 | Medicine: Aldara | Updated |
| 01/03/2024 | Page: Network Portfolio | Updated |
| 01/03/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - January 2024 | Updated |
| 01/03/2024 | Document: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (29 January 2024) | New |
| 01/03/2024 | Document: Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed)) | Updated |
| 01/03/2024 | Document: Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 19-22 February 2024 | New |
