PRAC highlights from May 2026 meeting

18th May 2026

Summary:
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) met from 4th to 7th May 2026 to review a range of medicine safety issues across the EU. The committee assessed new and ongoing safety signals, evaluated risk management measures, and made recommendations to ensure that medicines continue to have a positive benefit-risk balance. Updates included reviews of suspected adverse reactions, considerations for product information changes, and discussions on pharmacovigilance procedures aimed at improving patient safety. These outcomes contribute to ongoing monitoring efforts and inform regulatory actions across member states.

Link: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-may-2026

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