DateContentStatus
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 - Joint HMA/EMA Big Data Steering Group Workshop on RWE methodsUpdated
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 Event: CVMP Interested Parties’ meetingNew
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 Page: Information ManagementUpdated
02/05/2024 Herbal: Malvae sylvestris flos - herbal medicinal productUpdated
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 Page: Handling competing interestsUpdated
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 Page: Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guidelineUpdated
02/05/2024 Document: Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal productsNew
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
02/05/2024 Document: List of eligible industry stakeholder organisationsUpdated