EMA PRAC meeting highlights — 12–15 January 2026

21st January 2026

EMA PRAC meeting highlights — 12–15 January 2026

Summary:
At its 12–15 January 2026 meeting, PRAC continued its regular monitoring of post-authorisation safety information for medicines authorised in the EU. The Committee reviewed safety signals and ongoing risk-assessment procedures across a range of products, including updates to Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) submitted by Marketing Authorisation Holders. PRAC also assessed data from post-authorisation safety studies (PASS) to ensure that the benefit-risk profile of medicines remains positive in real-world use.

The Committee provided guidance to continue monitoring issues of interest — such as potential safety signals under review — and confirmed that no new safety referrals were initiated during this session. PRAC’s deliberations help support timely regulatory actions where new risks are confirmed or additional risk-minimisation measures are needed.

Link: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-12-15-january-2026

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