Date of Publication: 10-Feb-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting held on 24–27 November 2025. The document captures key discussions on safety signal evaluations, periodic safety update reports, risk management plans, post-authorisation safety studies, and ongoing benefit–risk assessments of centrally authorised medicines.
The minutes provide important insight into how emerging safety data is reviewed and how regulatory conclusions are shaped within the EU pharmacovigilance framework.
KEYWORDS: Pharmacovigilance, Safety Signal, Risk Management Plan (RMP)
REFERENCE: https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-24-27-november-2025_en.pdf