European Medicines Agency (EMA) 2025 Annual Report

Official summary:

"EMA released its 2025 annual report, highlighting progress in bringing innovative, safe and effective medicines to patients. The report outlines the most important achievements in evaluating and monitoring human and veterinary medicines along with a selection of key figures. The digital report includes improved accessibility features and is complemented by an interactive timeline of milestones, additional documents, audio-visual materials and infographics."

"Other important activities covered by the report include the Agency officially launching the EU Medicines Agencies Network Strategy (EMANS) to 2028, maintaining the Union list of Critical Medicines, and operating the European Shortages Monitoring Platform (ESMP) that became operational in 2025.

In addition, the report highlights the Agency’s preparation for the implementation of the new pharmaceutical legislation and explores how digitalisation and AI continued to transform EMA’s work in 2025 – moving from exploration to practical application.

The second chapter of the report is dedicated to core statistics and trends illustrating the Agency’s activities in the regulation of medicines. More detailed statistical information about EMA can be found in the Agency’s annual activity report which will be published prior to 1 July 2026."

Key figures from the report:

• In 2025, EMA recommended 104 human medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before.
• 3 positive opinions for medicines intended for use outside the EU.
• EMA recommended 30 medicines for marketing authorisation – the highest number of recommendations for a second consecutive year. Of these, 13 had a new active substance. 16 of the recommended human medicines were for the treatment of rare diseases.
• 16 of the veterinary medicines were vaccines, which was an increase from 14 vaccines in 2024. 7 of the vaccines were approved under exceptional circumstances to respond to animal health emergencies.