DateContentStatus
13/11/2024 PIP: EMEA-003359-PIP01-22 - paediatric investigation planNew
13/11/2024 PIP: EMEA-003357-PIP01-22 - paediatric investigation planNew
13/11/2024 PIP: EMEA-003356-PIP01-22 - paediatric investigation planNew
13/11/2024 PIP: EMEA-003342-PIP02-22 - paediatric investigation planNew
13/11/2024 PIP: EMEA-003445-PIP01-23 - paediatric investigation planNew
13/11/2024 PSUSA: PSUSA/00010442/202401 - periodic safety update report single assessmentNew
13/11/2024 Event: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 22 October 2024Updated
13/11/2024 Event: Public event: advancing regulatory science researchUpdated
13/11/2024 Event: Biannual Big Data Steering Group and industry stakeholders meeting - Oct 2024New
13/11/2024 Medicine: Zoledronic Acid AccordUpdated
13/11/2024 Medicine: ProliaUpdated
13/11/2024 Document: Minutes - HMA-EMA joint Big Data Steering Group teleconference - 6 September 2024New
13/11/2024 Event: Training webinar on post-authorisation procedure management in IRIS for Marketing Authorisation HoldersUpdated
13/11/2024 Event: Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicinesUpdated
13/11/2024 Event: Clinical Data Publication (Policy 0070) webinar - Step 2Updated
13/11/2024 Event: Third European Medicines Agency (EMA) and Vaccines Europe bilateral meetingUpdated
13/11/2024 Document: Agenda - Third EMA and Vaccines Europe bilateral meetingNew
13/11/2024 Event: Submission of Manufacturers, Manufacturing Business Operations (MBOs) and structured pack size data to Product Management Service (PMS)Updated
13/11/2024 Event: ACT EU workshop on ICH E6 R3 (principles and Annex 1) New
13/11/2024 Event: Third Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG)Updated
13/11/2024 Document: Report - 3rd Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG)New
13/11/2024 Medicine: BuccolamUpdated
13/11/2024 Page: MpoxUpdated
12/11/2024 Medicine: EloctaUpdated
12/11/2024 Medicine: PaxlovidUpdated
12/11/2024 Medicine: VekluryUpdated
12/11/2024 Medicine: Posaconazole AHCLUpdated
12/11/2024 Medicine: AlecensaUpdated
12/11/2024 PSUSA: PSUSA/00001890/202401 - periodic safety update report single assessmentNew
12/11/2024 Medicine: BimzelxUpdated
12/11/2024 Page: CHMP opinions on consultation proceduresUpdated
12/11/2024 Page: EudraVigilance training and supportUpdated
12/11/2024 Medicine: ZaviceftaUpdated
12/11/2024 Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - FebruaryNew
12/11/2024 Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - MayNew
12/11/2024 Document: Agenda - Second European Medicines Agency (EMA) and IPFA - PPTA global bilateral meetingNew
12/11/2024 Document: Medicinal products for human use: monthly figures - October 2024New
12/11/2024 Event: New fee regulation: webinar for industry stakeholders (human)Updated
12/11/2024 Event: Paediatric Committee (PDCO): 12-15 November 2024Updated
12/11/2024 Document: Public call for expression of interest for experts to become members of the European Medicines Agency's scientific advisory groupsNew
12/11/2024 Document: Irvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultationUpdated
12/11/2024 Document: Ketoprofen (all ruminants, porcine and Equidae) - Summary opinion of the CVMP on the extension of maximum residue limitsUpdated
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance systemNew
12/11/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - November 2024Updated
12/11/2024 Referral: Azithromycin-containing medicinal products for systemic use - referralUpdated
11/11/2024 Medicine: UltomirisUpdated
11/11/2024 Event: Quarterly system demo - Q4 2024New
11/11/2024 Medicine: HepcludexUpdated
11/11/2024 Document: Agenda of the CHMP meeting 11-14 November 2024New
11/11/2024 Event: Translating innovation into access for ATMPs: 3rd EU-Innovation network multi-stakeholder meetingUpdated
11/11/2024 Medicine: AlprolixUpdated
11/11/2024 Medicine: Capecitabine AccordUpdated
11/11/2024 Medicine: BeovuUpdated
11/11/2024 Document: Highlights – sixth EMA/EuropaBio bilateral meetingNew
11/11/2024 Document: Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2024Updated
11/11/2024 Medicine: ConveniaUpdated
11/11/2024 Medicine: CepedexUpdated
11/11/2024 Medicine: CardalisUpdated
08/11/2024 Medicine: RefixiaUpdated
08/11/2024 Medicine: AdynoviUpdated
08/11/2024 Event: Human variation electronic application form (eAF) training session and Q&A clinicUpdated
08/11/2024 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
08/11/2024 Document: Agenda - Medicine Shortages (SPOC) Working Party 6 November 2024New
08/11/2024 Post-authorisation: Simparica Trio - opinion on variation to marketing authorisationNew
08/11/2024 Medicine: Carprofen OrionNew
08/11/2024 News: First certification of a veterinary vaccine platform technology master fileNew
08/11/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 November 2024New
08/11/2024 Medicine: VevizyeUpdated
08/11/2024 Event: New fee regulation: webinar for veterinary industry stakeholdersUpdated
08/11/2024 Medicine: TasmarUpdated
08/11/2024 DHPC: Pegasys - direct healthcare professional communication (DHPC)New
08/11/2024 Medicine: OmidriaUpdated
08/11/2024 Document: Revised list of enabling toolsNew
07/11/2024 Document: Meeting Summary of the Medicine Shortages SPOC Working Party meeting - 11 September 2024New
07/11/2024 Document: Applications for new human medicines under evaluation: November 2024New
07/11/2024 Medicine: KeppraUpdated
07/11/2024 Medicine: Canigen L4Updated
07/11/2024 Medicine: BroadlineUpdated
07/11/2024 Medicine: ZegalogueUpdated
07/11/2024 Medicine: BovelaUpdated
07/11/2024 Medicine: M-M-RVaxProUpdated
07/11/2024 PSUSA: PSUSA/00003149/202308 - periodic safety update report single assessmentNew
07/11/2024 Medicine: NucalaUpdated
07/11/2024 Medicine: Trixeo AerosphereUpdated
07/11/2024 Post-authorisation: Metalyse - opinion on variation to marketing authorisationUpdated
06/11/2024 Medicine: Versican Plus Pi/L4Updated
06/11/2024 Medicine: Versican Plus PiUpdated
06/11/2024 Medicine: Versican Plus L4Updated
06/11/2024 Medicine: Innovax-ND-IBDUpdated
06/11/2024 Medicine: Vaxxitek HVT+IBDUpdated
06/11/2024 Medicine: WyostUpdated
06/11/2024 Medicine: Porcilis PCV M HyoUpdated
06/11/2024 Medicine: Poulvac E. coliUpdated
06/11/2024 Medicine: ByettaUpdated
06/11/2024 Medicine: XeravaUpdated
06/11/2024 Medicine: Riltrava AerosphereUpdated
06/11/2024 Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authoritiesUpdated
06/11/2024 Document: European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holdersUpdated
06/11/2024 PSUSA: PSUSA/00000300/202403 - periodic safety update report single assessmentNew
06/11/2024 Medicine: KinpeygoUpdated
06/11/2024 Event: SPOR Status UpdateUpdated
06/11/2024 Medicine: TofidenceUpdated
06/11/2024 Medicine: XalkoriUpdated
06/11/2024 Medicine: Pemetrexed SandozUpdated
06/11/2024 Medicine: KeytrudaUpdated
06/11/2024 Page: Emergency Task Force (ETF)Updated
06/11/2024 Event: Committee for Advanced Therapies (CAT): 6-8 November 2024Updated
06/11/2024 Document: Agenda of the CAT meeting 6-8 November 2024New
05/11/2024 Medicine: Porcilis ColiClosUpdated
05/11/2024 Medicine: ArthriCoxUpdated
05/11/2024 Event: 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilanceNew
05/11/2024 Document: Agenda of the COMP meeting 5-7 November 2024New
05/11/2024 Medicine: Cirbloc M HyoUpdated
05/11/2024 Page: Executive Steering Group on Shortages and Safety of Medicinal ProductsUpdated
05/11/2024 Event: EMA risk management information day 2024New
05/11/2024 Document: Nominations to the Network Portfolio Advisory GroupUpdated
05/11/2024 Medicine: YuflymaUpdated
05/11/2024 Page: Stakeholder participation in information managementUpdated
05/11/2024 Event: Fourth listen-and-learn focus group meeting of the Quality Innovation GroupUpdated
05/11/2024 Medicine: Nobivac DP PlusUpdated
05/11/2024 Page: SME Regulation and reportsUpdated
05/11/2024 Medicine: Hiprabovis IBR Marker LiveUpdated
05/11/2024 Medicine: AdvagrafUpdated
05/11/2024 PSUSA: PSUSA/00000007/202312 - periodic safety update report single assessmentNew
05/11/2024 Page: Vaccines Working PartyUpdated
05/11/2024 Document: Draft consolidated 3-year rolling work plan for the Vaccine Working Party (VWP) - 2025-2027New
05/11/2024 Medicine: ModigrafUpdated
05/11/2024 Medicine: VidazaUpdated
05/11/2024 Medicine: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)Updated
05/11/2024 Medicine: CejemlyUpdated
05/11/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - October 2024Updated
05/11/2024 Document: EVVet3 EVWeb Production - Release notesUpdated
05/11/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - September 2024Updated
04/11/2024 PSUSA: PSUSA/00002170/202403 - periodic safety update report single assessmentNew
04/11/2024 PSUSA: PSUSA/00010802/202403 - periodic safety update report single assessmentNew
04/11/2024 Medicine: QdengaUpdated
04/11/2024 Document: Minutes of the CHMP meeting 27-30 May 2024New
04/11/2024 Document: PDCO minutes of the 3-6 September 2024 meetingNew
04/11/2024 Medicine: AflunovUpdated
04/11/2024 Document: Network ICT Advisory Committee (NICTAC) - List of nominated membersUpdated
04/11/2024 Medicine: TrydonisUpdated
04/11/2024 EU-M4all: Dengue Tetravalent Vaccine (Live, Attenuated) TakedaUpdated
04/11/2024 Page: Questions and answers on Article 82 referral proceduresNew
04/11/2024 Medicine: PradaxaUpdated
04/11/2024 Medicine: LibtayoUpdated
04/11/2024 Page: Questions and answers on Article 82 referral procedures based on Article 129(3)New
04/11/2024 PSUSA: PSUSA/00009162/202403 - periodic safety update report single assessmentNew
04/11/2024 PSUSA: PSUSA/00001997/202403 - periodic safety update report single assessmentNew