Meeting Highlights – European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 24–27 November 2025

2nd December 2025

Meeting Highlights – European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 24–27 November 2025

Summary:

• During this session, PRAC conducted its full range of responsibilities — evaluating safety signals, reviewing periodic safety update reports (PSURs), risk-management plans (RMPs), and post-authorisation safety studies (PASSs). 

• Notably, the Committee did not start or conclude any new referral procedures this month. 

• The meeting record confirms that existing safety reviews remain ongoing, including for products under procedures related to levamisole-containing medicinal products. 

Link: Meeting highlights – PRAC 24–27 November 2025

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