Forewordby Rui Santos Ivo

I would also like to extend my warm congratulations to our Executive Director, Emer Cooke, on the extension of her mandate until the end of April 2027. Under her leadership, the Agency is well positioned to confidently and collectively navigate the opportunities and challenges ahead, particularly with the revision of the EU pharmaceutical legislation.

This report highlights the remarkable progress we are making in medicines regulation today. Among the many important developments highlighted in this report, the continued momentum in the field of veterinary medicines stands out. For the second consecutive year, EMA has recommended an unprecedented number of veterinary medicines for approval. This suggests the positive impact of the Veterinary Medicines Regulation, introduced in 2022, in fostering product innovation across the European Union (EU).

In 2025, we celebrated EMA’s 30th anniversary and looked back over three decades of medicines regulation with our eyes on the future. EMA’s scientific conference in Amsterdam in June was especially significant in celebrating the role of science in our societies, as well as the latest trends, innovations, and challenges in the field of medicines regulation. I enjoyed meeting past and present EMA and network representatives during the event. We all share enduring values: collaboration, integrity, scientific excellence, and an unwavering commitment to public and animal health.

These are also values being instilled in the newly formed African Medicines Agency, whose Governing Board and heads of African national agencies attended a first-of-its-kind meeting with EMA’s Management Board in June. This was a special and significant moment for the European and African regulatory networks, and it allowed our counterparts to gain insights into the governance and supervisory role of the Management Board across a broad range of activities, including strategic, financial and operational matters.

Currently, we are operating in a period of rapid transformation, defined by new ways of working and major legislative changes. These developments underscore how essential it is for EMA and the network to remain forward looking, agile, efficient, and firmly committed to safeguarding the EU’s high standards for human and animal health while serving all European citizens. They also highlight the need for ever-closer coordination and solidarity across the European medicines regulatory network as we respond to shared pressures on resources, expertise and capacity.

In 2025, we officially launched our EU Medicines Agencies Network Strategy (EMANS) to 2028. This strategy places greater emphasis on the competitiveness of the EU in the development and manufacture of medicines, as well as the use of data and artificial intelligence throughout the medicines lifecycle, and aims to foster innovation, access, emergency preparedness, and sustainability. Preparation is underway for the implementation of the new EU pharmaceutical legislation, including significant investment in the development of staff across the European medicines regulatory network.

With so much change driven by rapid digitalisation, EMANS provides the strategic roadmap to ensure increased demand and manage structural changes effectively. It highlights the importance of continuous learning, upskilling and the development of new capabilities across our network, where the EU Network Training Centre provides comprehensive, high quality scientific and regulatory training, which is now more accessible than ever.

Bringing together assessors and experts from key scientific disciplines — clinical, non-clinical, quality and pharmacovigilance — and from across the EU/European Economic Area (EEA) national competent authorities, provides a unique opportunity to connect, network and share knowledge and experiences, developing a stronger sense of community and enhancing collaboration across the EU medicines regulatory network. Such initiatives are essential to building a truly integrated community of experts, able to respond consistently and effectively to emerging scientific and regulatory challenges.

Another key priority that gathered momentum in 2025 is our work to modernise clinical trials in the EU so it can be a leading destination for clinical research and innovation. I can see we have the tools and unity of purpose to deliver. Central to this transformation is the Clinical Trials Information System (CTIS), which serves as the single-entry point for sponsors and regulators to submit, assess, and oversee trials across the EU. Since its launch in 2022, CTIS has received an increasing number of applications which, in conjunction with other initiatives, ensures a strong axis to this priority.

I believe we are ready as a network for the challenges the future brings, and as Chair of the Management Board, I will continue to focus on supporting the outstanding work of our scientists in Europe, together with my fellow Board members.

Looking ahead, we will focus on prioritising and reinforcing the valuable partnership EMA shares with national agencies and the European Commission, while jointly upholding the strong international reputation of the EMA as a reference regulator.

Thank you for making my first year in this position so memorable. I would like to extend my sincere thanks also to our partners at the European Commission for their collaboration and continued support. My gratitude also goes to my fellow Board members and colleagues in our network, and to the EMA staff, whose commitment, drive and dedication to public health in the European Union is exemplary and underpins our work every day.