DateContentStatus
08/05/2024 Document: Timetable: Post-authorisation safety study (PASS) protocols and final resultsUpdated
07/05/2024 Medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca)Updated
07/05/2024 Herbal: Hippocastani cortex - herbal medicinal productUpdated
07/05/2024 News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024Updated
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 Page: PRIME: priority medicinesUpdated
07/05/2024 Document: List of medicines currently in PRIME schemeUpdated
07/05/2024 Medicine: EmblaveoUpdated
07/05/2024 News: One Health: a joint framework for action published by five EU agenciesNew
07/05/2024 Page: COVID-19 vaccines: key factsUpdated
06/05/2024 Event: EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcomaUpdated
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 Referral: Synapse - referralUpdated
06/05/2024 Medicine: AdynoviUpdated
06/05/2024 Medicine: AdvateUpdated
06/05/2024 Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modificationUpdated
06/05/2024 Document: List of signals discussed at PRAC since September 2012Updated
06/05/2024 Document: PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meetingNew
03/05/2024 Medicine: MenQuadfiUpdated
03/05/2024 PIP: EMEA-002754-PIP01-19 - paediatric investigation planUpdated
03/05/2024 PIP: EMEA-002693-PIP01-19 - paediatric investigation planUpdated
03/05/2024 PIP: EMEA-003157-PIP01-21 - paediatric investigation planUpdated
03/05/2024 PIP: EMEA-001666-PIP01-14-M01 - paediatric investigation planUpdated
03/05/2024 Document: Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicinesUpdated
03/05/2024 Event: Third European Medicines Agency and Affordable Medicines Europe bilateral meetingUpdated
03/05/2024 PSUSA: PSUSA/00002589/202307 - periodic safety update report single assessmentNew
03/05/2024 Medicine: BriumviUpdated
03/05/2024 Document: Sponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23Updated
03/05/2024 Medicine: TevimbraUpdated
03/05/2024 Event: Q&A Clinic for IRIS Network users for transitioned regulatory proceduresNew
03/05/2024 Medicine: SivextroUpdated
03/05/2024 Medicine: TalzennaUpdated
03/05/2024 Page: ICH M10 on bioanalytical method validation - Scientific guidelineUpdated
03/05/2024 Page: Plasma master file certificatesUpdated
03/05/2024 Page: Big dataUpdated
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 Document: Template for scientific document (part B-F)Updated
02/05/2024 Document: Scientific recommendations on classification of advanced therapy medicinal productsUpdated
02/05/2024 Document: Appendix 1: Acceptable intakes established for N-nitrosaminesUpdated
02/05/2024 Medicine: PelmegUpdated
02/05/2024 Medicine: NoxafilUpdated
02/05/2024 Medicine: Teriflunomide AccordUpdated
02/05/2024 Medicine: ByoovizUpdated
02/05/2024 Medicine: PluvictoUpdated
02/05/2024 Medicine: RotaTeqUpdated
02/05/2024 Medicine: TracleerUpdated
02/05/2024 Medicine: StayveerUpdated
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 Medicine: VolibrisUpdated
02/05/2024 Herbal: Malvae folium - herbal medicinal productUpdated
02/05/2024 Medicine: VafseoUpdated
02/05/2024 Medicine: IncellipanUpdated
02/05/2024 Medicine: CelldemicUpdated
02/05/2024 Medicine: ZynyzUpdated
02/05/2024 Document: CAT quarterly highlights and approved ATMPs - February - April 2024New
02/05/2024 Page: Quality of medicines questions and answers: Part 1Updated
02/05/2024 Medicine: MirapexinUpdated
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