Emer Cooke, EMA’s Executive Director: 2025 achievements in medicine regulation

19 December 2025

EMA's Executive Director shares her end-of-year message and takes stock of EMA's work in 2025.

2025 was a special year for EMA, its staff and the whole European Medicine Regulatory Network, as it marked three decades since the inception of the Agency, three decades of progress in science and medicines across the EU.

This year is also special because it sets us up for a bright future ahead. The agreement on the new pharmaceutical legislation is a historic milestone for medicines regulation in Europe and for patients across the EU, a golden opportunity to become more agile and efficient. Our direction is clear: a fast path from innovation to safe and effective medicines. Towards this vision, in 2026, we will focus our efforts in three areas:

First, we will take advantage of the strengthened legislative framework to reimagine how EMA works. We have a unique opportunity to adapt our regulatory system to deal with rapid scientific and technological advances, while increasing efficiency through smart digitalisation and use of artificial intelligence.

Second, we will intensify our support for innovation for public and animal health. We will further enhance our early development support to enable new medicines to be authorised in the EU as rapidly as possible.

Third, we will continue to invest in our staff and build the network of tomorrow. This investment in the European medicines regulatory network’s workforce will help build capacity and capability so that we can fully embrace the new challenges and opportunities that lie ahead.

At the end of the year, we can look with pride at its achievements. In 2025, we recommended 104 new medicines for human use. Almost 40% of them contain a completely new active substance. In the veterinary area, we recommended a record-breaking 30 new medicines, among them several new vaccines. There were many remarkable new treatments, both in human and veterinary medicine, and let me highlight just a few:

• the first treatment to delay the onset of stage 3 type 1 diabetes in adults and children from 8 years of age;
• the first treatment against Duchenne muscular dystrophy in patients from the age of six who can walk;
• the first vaccine in the EU to protect adolescents from the age of 12 against Chikungunya;
• two new bluetongue vaccines to protect sheep and cattle.

Beyond the evaluation of new medicines, we recommended changes to the way the antibiotic azithromycin is used in the EU to minimise the development of antimicrobial resistance. We also recommended measures to minimise the risk of suicidal thoughts with finasteride and dutasteride medicines, used by men to treat androgenetic alopecia.

2025 has yet again proven that when we collaborate, we can achieve anything.

EMA, the Commission and the Heads of Medicines Agencies set new ambitious targets to increase the number of multinational clinical trials taking place in the EU. We also launched a new clinical trials map in all EU languages to provide patients and healthcare professionals with easy access to comprehensive, real-time information about clinical trials conducted in their area.

The strength of a coordinated system is key to addressing the shortages problem at EU level. The launch of the European Shortages Monitoring Platform in January 2025 provides a strong technical backbone for our work with EU national authorities and actors across the supply chain to prevent and manage shortages.

We embraced new partnerships and strengthened the ones we have, to rebuild trust in science. Timely, clear and accurate health information - delivered with empathy and targeted to the needs of diverse audiences - is crucial to our public health mission.

We coordinated communication campaigns with national competent authorities, the European Commission, our sister agencies and organisations representing patients and healthcare professionals. To expand our reach and diversify our audiences, we worked with content creators for the first time to promote safe and responsible use of GLP-1 medicines. In an environment where misinformation spreads faster than facts, we must embrace innovative approaches to communication and stakeholder engagement.

Europe has always been a place where ideas spark change. It has world-class science and world-class expertise. We need to protect and promote these strengths. We need a Europe where facts matter, innovation thrives, and collaboration wins. The future is ours to shape - let’s shape it together, with science.