Election of new Management Board Chair
At its March meeting, EMA’s Management Bord elected Rui Santos Ivo as new chair of the Board for a three-year period. Mr Santos Ivo is president of the Portuguese National Authority of Medicines and Healthcare Products (Infarmed) and an associate professor of medicines regulation at the University of Lisbon, Faculty of Pharmacy. He has been a member of the EMA Management Board since 2016 and has served as its vice chair since October 2024. The Board also thanked Lorraine Nolan, Chief Executive of the Irish Health Products Regulatory Authority (HPRA), for her leadership as chair between 2022 and 2025. More details are available in a separate news announcement.
EMA annual report 2024
The Board adopted EMA’s annual report for 2024. Last year, the Agency issued its highest number of positive recommendations for new medicines in 15 years, delivering recommendations for 114 new medicines for human use. Among these, 46 had a new active substance. The Agency also recommended 25 veterinary medicines for marketing authorisation - the highest ever number of recommendations in a year.
The report also highlights EMA’s efforts to strengthen processes and procedures to ensure that the European medicines regulatory network can harness health data and benefit from rapid technological advancements, especially the use of artificial intelligence for the benefit of patients. It also includes an update on EMA’s work to build strong partnerships across the European medicines regulatory network and internationally for a collaborative approach to medicines regulation and global health. Publication of the annual report, including an interactive digital version, is planned for May 2025.
European Medicines Agencies Network Strategy to 2028
The Board adopted the joint European Medicines Agencies Network Strategy (EMANS) to 2028. The strategy, titled ‘Seizing opportunities in a changing medicines landscape’, is a comprehensive review and update of the five-year strategy which was developed to cover the period 2021 to 2025 (EMANS 2025). Extending the timeframe to 2028, the update takes into account progress made to date and the technological advances, environmental challenges and other developments that are reshaping the regulatory landscape. This will lay the groundwork to prepare the network for the implementation of the revised EU pharmaceutical legislation.
The final document will be published shortly, with a separate news announcement.
Revised composition of EMA’s Emergency Task Force
The Board adopted a revised composition of EMA’s Emergency Task Force (ETF) following the departure of four of its members and the expansion of its activities to include selected antimicrobial resistance (AMR) related pathogens. The new composition of the ETF will ensure continuity in EMA’s readiness to protect European citizens from emerging health threats, while also expanding expertise in the critical area of AMR. The revised composition of the task force will be published shortly.
Monitoring EMA’s independence policies
The Board endorsed EMA’s annual report on the implementation of the Agency’s policies related to the independence of members and experts of its scientific committees, Management Board members, Agency staff and members of medical device expert panels.
The report provides facts and figures on controls carried out in 2024 and identifies recommendations for further improvements in 2025, including activities related to the implementation of the recently revised policies on the handling of competing interests of scientific committee members and experts (‘Policy 0044’) and Board members (‘Policy 0058’) that will become effective on 1 May 2025.
The report will be published on the EMA website shortly.
Clinical Trials in the EU
The Board was updated on the 2025 plans for development of the Clinical Trial Information System (CTIS), which focus on further improving the user experience, together with system simplification and modernisation. The Board also received a live demonstration of the new clinical trial map that is accessible from the CTIS public website. The map provides patients and healthcare professionals with easy access to comprehensive, real-time information about clinical trials, including which trials are recruiting and providing contact details for specific trial sites. It responds to requests for a simple, patient-friendly dashboard for CTIS to help stakeholders, particularly patients, locate clinical trials of interest in Europe. The creation of the map facilitates access to clinical research and is an action of the Accelerating Clinical Trials in the European Union (ACT EU) initiative workplan for 2025-2026.