EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines
Report highlights progress in science, medicines and health in 2025
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Today, 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.
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.
EMA’s efforts further extended to global public health, with three positive opinions for medicines intended for use outside the EU.
On the veterinary side, 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.
Sixteen of the veterinary medicines were vaccines, which was an increase from 14 vaccines in 2024. Seven of the vaccines were approved under exceptional circumstances to respond to animal health emergencies.
For EMA, 2025 was a particularly special year as it marked the Agency’s 30th anniversary – three decades cultivating a world-class regulatory network and making medicines safe and effective for 450 million people and countless animals across the EU. The year also marked the 25th anniversary of the EU Orphan Regulation, which has played a central role in facilitating the development and authorisation of medicines for rare diseases. Sixteen of the recommended human medicines were for the treatment of rare diseases.
The report contains the major achievements of EMA’s scientific committees for 2025 and highlights their strategic goals for the years ahead.
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.
As usual, 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.