ICH E2D post-approval safety data management - scientific guideline
ICH E2D post-approval safety data management - scientific guideline
ICH E2D post-approval safety data management - scientific guideline
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
Highlight report - Combination Products Operational Group (COMBO) - In Vitro Diagnostics stream - February 2026
Darwin EU: Making health data count
PSUSA/00000594/202506
Human medicines European public assessment report (EPAR): MicardisPlus, telmisartan,hydrochlorothiazide, Date of authorisation: 19/04/2002, Revision: 37, Status: Authorised
Human medicines European public assessment report (EPAR): Tyruko, natalizumab, Date of authorisation: 22/09/2023, Revision: 3, Status: Authorised
16th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 31 March 2026, 13:00 (CEST) to 31 March 2026, 18:00 (CEST)
PSUSA/00002846/202504
Orphan designation: Overview