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EMA newsOct 2, 2026

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October

EMA reports that its safety committee, PRAC, reviewed safety signals, risk management plans, periodic safety reports and post-authorisation safety studies at its monthly meeting. These assessments concern medicine developers and authorisation holders; no referral procedures were started or concluded.

Why it matters: EMA reports that PRAC reviewed seven post-authorisation safety study protocols and nine study results.

Safety and recallsAI summary
Read at EMA

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