Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2026

WHY IT MATTERS

If you take a medicine approved in Europe, this committee's work directly affects whether that drug stays on the market or gets new safety warnings added to its label.

The European Medicines Agency held its monthly safety meeting in May 2026 to review how medicines are being used and whether they're causing any unexpected side effects. The committee looked at new safety concerns and checked on medicines already approved in Europe to make sure they're still safe for patients.

Source: European Medicines Agency (EMA) Description: At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 4-7 May 2026Draft Reference Number…, PRAC statistics: May 2026 , PRAC statistics: May 2026 English (EN) (104.16 KB - PDF)First published:…, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known as Published: 2026-05-08T10:00:00.000Z Note: EMA announcements cover medicines approved in the EU. Orphan designations may not yet be available in the US.