DateContentStatus
17/05/2024 PSUSA: PSUSA/00010768/202310 - periodic safety update report single assessmentNew
17/05/2024 Event: Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portalNew
17/05/2024 News: Hydroxyprogesterone caproate medicines to be suspended from the EU marketNew
17/05/2024 News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024New
17/05/2024 Document: Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan AfricaNew
16/05/2024 PSUSA: PSUSA/00002569/202309 - periodic safety update report single assessmentNew
16/05/2024 PSUSA: PSUSA/00000034/202309 - periodic safety update report single assessmentNew
16/05/2024 PSUSA: PSUSA/00010806/202310 - periodic safety update report single assessmentNew
16/05/2024 Document: Sodium tetradecyl sulphate: List of nationally authorised medicinal products - PSUSA/00002767/202304 New
16/05/2024 Document: PDCO minutes of the 19-22 March 2024 meetingNew
16/05/2024 News: EMA closed on Whit Monday, 20 MayNew
16/05/2024 Document: Meeting Summary of the Medicine Shortages (SPOC) Working Party - 14 March 2024New
16/05/2024 Document: Agenda - Medicine Shortages (SPOC) Working Party 14 March 2024New
16/05/2024 Document: Records of data processing activity for study of the “Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV- during the Omicron period”New
16/05/2024 Document: European Medicines Agency's data protection notice on the study of the “Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV- during the Omicron period”New
16/05/2024 Event: Quarterly System Demo – Q2 2024New
14/05/2024 Document: Minutes of the PRAC meeting 4-7 March 2024New
07/05/2024 News: EMA closed 9-10 MayNew
07/05/2024 Event: Information session on Call for Proposals "EU 4 AMA: leveraging European expertise for medicines regulation in Africa"New
07/05/2024 News: One Health: a joint framework for action published by five EU agenciesNew
06/05/2024 Document: Records of data processing activity for audiovisual tool for checking presence in meeting roomsNew
06/05/2024 Document: European Medicines Agency’s data protection notice for the audiovisual tool for checking presence in meeting roomsNew
06/05/2024 PSUSA: PSUSA/00002310/202308 - periodic safety update report single assessmentNew
06/05/2024 Document: Meeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma WorkshopNew
06/05/2024 Document: Minutes of the COMP meeting 12-14 March 2024New
06/05/2024 Document: PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meetingNew
03/05/2024 PSUSA: PSUSA/00002589/202307 - periodic safety update report single assessmentNew
03/05/2024 Page: Real-world evidenceNew
03/05/2024 Page: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guidelineNew
03/05/2024 Document: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidenceNew
02/05/2024 Event: CVMP Interested Parties’ meetingNew
02/05/2024 Document: Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS ProcedureNew
02/05/2024 Event: EU NTC ten year anniversary eventNew
02/05/2024 Document: CAT quarterly highlights and approved ATMPs - February - April 2024New
02/05/2024 Document: Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal productsNew
02/05/2024 Document: Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to LabellingNew