Introductionby Emer Cooke

Breakthroughs for humans and animals

At the heart of our work is the impact we make on people’s lives. In 2025, EMA recommended 104 medicines for human use for marketing authorisation in the EU. This includes medicines representing important innovation or contributions to public health.

Among them:

• A treatment for bladder cancer, one of the most common cancers in the EU, affecting over 200,000 people each year.
• A vaccine to protect young people from 12 years of age and adults against disease caused by the Chikungunya virus.
• The first oral medicine to treat postpartum depression following childbirth (Zurzuvae).

Out of the 104 recommended medicines, 16 were for the treatment of a rare disease. Our efforts extended to global public health, with three positive opinions for medicines intended for use outside the EU, including a medicine to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents. Veterinary medicines also achieved new heights in 2025. For the second year in a row, EMA recommended a record number of veterinary medicines for approval, highlighting how the 2022 Veterinary Medicines Regulation fosters innovation. Thirty medicines in total were recommended for marketing authorisation, including 16 vaccines and 13 medicines with a new active substance, which had not previously been authorised in the EU.

Realising the opportunity of the new pharmaceutical legislation

Europe’s life science landscape is transforming fast. The revision of the EU pharmaceutical legislation presents a once-in-a-generation opportunity to simplify, integrate and modernise the medicines framework. It offers us new scope to address availability and supply of medicines in Europe and support our commitment to build public trust in medicines regulation.

With the political agreement reached between the European Commission, Parliament and Council, we are set to realise our ambition to build a more streamlined, modern regulatory system that provides a fast path from innovation to safe and effective medicines. The legislation introduces instruments fit for today’s science: regulatory sandboxes, platform technology approaches, strengthened availability obligations and clearer pathways for advanced therapies. This modernisation is further bolstered by the upcoming EU Biotech Act, which aims to remove barriers to innovation and boost Europe’s global competitiveness. EMA is ready to ensure these pieces of legislation translate into real-world results through our support for developers across the medicines lifecycle.

The legislation introduces instruments fit for today’s science: regulatory sandboxes, platform technology approaches, strengthened availability obligations and clearer pathways for advanced therapies. This modernisation is further bolstered by the upcoming EU Biotech Act, which aims to remove barriers to innovation and boost Europe’s global competitiveness. EMA is ready to ensure these pieces of legislation translate into real-world results through our support for developers across the medicines lifecycle.

Unifying to address availability

Ensuring availability of medicines remains one of our most unifying challenges – and responsibilities. Over the past few years, the Agency’s expanded mandate has positioned us as the central coordinator for the EU’s response to medicines shortages, shifting from reactive mitigation to proactive, data-driven preparedness.

We maintain the Union List of Critical Medicines andoperate the European Shortages Monitoring Platform (ESMP), which became operational in 2025, to ensure rapid information exchange on supply and demand with regulators and companies.

Working side-by-side with Member States, we activated the Voluntary Solidarity Mechanism on multiple occasions to resolve critical shortages, and we issued targeted recommendations to secure continuity of supply of certain medicines.

Looking ahead, the Critical Medicines Act will introduce complementary instruments that will help to fortify the EU’s resilience and protect patients against medicine shortages. In many ways, this work shows Europe its best: coordinated, proactive and all invested in solving a common public health problem.

Turning data into decisions

Digitalisation and AI continued to transform our work in 2025 as we moved from exploration to implementation. In July, we published our first Observatory Report showcasing real AI use across the medicines network, including seven qualification procedures and four scientific advice processes related to AI tools. These included deep learning-based image analysis for liver disease, machine learning to assess radiographic progression in psoriatic arthritis, and digital twins in rare disease trials.

We also aligned with partners on how best to regulate this fast-developing technology. Together with the FDA, we developed principles for the use of AI in medicine development, from early research and clinical trials to manufacturing and safety monitoring. Across EMA, more than 100 AI use cases are being explored – from support in drafting assessment reports to improving signal detection and enhancing shortage management.

DARWIN EU reached a new scale in 2025 with a threefold rise in studies to support our understanding of medicines usage in Europe. It now includes 30 data partners across 16 countries, covering approximately 180 million patients. DARWIN EU studies in 2025 supported high‑impact regulatory and public health questions, including: safety assessments such as suicidality risks linked to doxycycline and GLP‑1 agonists, monitoring medicine shortages, and evaluations of mpox vaccine effectiveness.

Contributing to public health globally

In an increasingly unpredictable world where public health challenges routinely cross-national borders, our international partnerships have never been more vital. From further supporting the establishment of the African Medicines Agency (AMA) to continued work on harmonisation of scientific guidelines (ICH and VICH) and collaborations with the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA), 2025 was a year in which we continued to strengthen our global ties in response to a growing need for coordination and alignment.

In June, EMA hosted a landmark meeting at our Amsterdam office, bringing together the AMA Governing Board and the heads of several African national authorities as observers to meet with the EMA Management Board. It was the first meeting of its kind between the European and African regulatory networks. There is an abundant need for smart, effective, and coordinated medicines regulation, and collaboration is essential to finding sustainable solutions to shared regulatory challenges.

In October, my final ICMRA Summit as chair featured discussions on our evolving role as communicators and on key topics such as reliance and developing common approaches to AI. Even though EMA’s two mandates at the helm of the coalition have now been completed, as a member of the Coalition, I remain deeply committed to supporting its work and objectives in the years ahead.

Last year also marked a decade of formal collaboration with the WHO. Together, we have tackled global health challenges through scientific cooperation, capacity-building, and efforts to enhance regulatory efficiency. This long-standing partnership remains a cornerstone of our global engagement.

Making a difference for every patient

WHO launched a public health campaign in 2024 on the theme that antimicrobial resistance is invisible, but its victims are not. This campaign highlights the silent crisis that antimicrobial resistance has become, causing 35,000 deaths annually in Europe and imposing significant costs on all systems. Coordinated action is essential to combat this health crisis.

The International Coalition of Medicines Regulatory Authorities (ICMRA) provides a unique platform for international regulators and other key stakeholders to develop strategic responses to antimicrobial resistance. At the 11th ICMRA Summit in November 2024, EMA co-chaired a crucial panel discussion on this topic where international regulators shared feedback and insights. This led to the publication of a statement reiterating the critical importance of preserving the effectiveness of antimicrobials and the crucial role regulators play in addressing the challenge collaboratively.

On the veterinary side we have a remarkable success story to tell. One of our past projects, the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project, has significantly reduces sales of veterinary antibiotics in the EU. ESVAC was a voluntary project – a concerted effort by farmers, veterinarians and national authorities – that led to sales of veterinary antibiotics in Europe dropping by more than 50 % over 12 years. This demonstrates that we can reduce antimicrobial resistance through a combination of monitoring, collecting data and communication. These principles are now embedded in EU legislation. The collection of data on sales and use of veterinary antimicrobials is now mandatory for all Member States.