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…