Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (EMEA/V/MRL/003649/MODF/0004)
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
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
Human medicines European public assessment report (EPAR): Waskyra, etuvetidigene autotemcel, Date of authorisation: 09/01/2026, Status: Authorised