EMA annual report 2025

The Management Board adopted EMA’s annual report for 2025, marking another strong year for medicines regulation in the European Union. EMA delivered 104 positive recommendations for new medicines for human use, including 38 containing a new active substance. The Agency also issued 30 recommendations for new veterinary medicines – the highest number of recommendations for a second consecutive year.

The report highlights key steps taken to optimise medicines assessments, improve access and strengthen medicines availability across the EU. It also outlines EMA’s role in implementing the Health Technology Assessment Regulation, coordinating actions to prevent and mitigate shortages and reinforcing the resilience of the EU medicines regulatory network.

The report, including an interactive digital version, will be published in May 2026.

Preparations for implementation of the new EU pharmaceutical legislation

The Board was updated that the new EU…