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The Management Board adopted EMA’s annual report for 2025, marking another strong year for medicines regulation in the European Union. EMA delivered 104 positive recommendations for new medicines for human use, including 38 containing a new active substance. The Agency also issued 30 recommendations for new veterinary medicines - the highest number of recommendations for a second consecutive year.
The report highlights key steps taken to optimise medicines assessments, improve access and strengthen medicines availability across the EU. It also outlines EMA’s role in implementing the Health Technology Assessment Regulation, coordinating actions to prevent and mitigate shortages and reinforcing the resilience of the EU medicines regulatory network.
The report, including an interactive digital version, will be published in May 2026.
The Board was updated that the new EU pharmaceutical legislation implementation governance structure is largely in place for EMA and the network, with leads nominated for the workstreams and all EMA and Management Board sponsors confirmed. The governance structure reflects the necessary joint work on the new legislation by the European Commission, EMA and the EU national competent authorities.
Once the texts have been formally adopted by the Council and the European Parliament, the European Commission will develop a series of delegated and implementing acts with further details on the new requirements and procedures. In addition, EMA will develop guidance to support applicants and marketing authorisation holders in understanding and complying with the new legal framework.
The Board noted the draft roadmap for a coordinated roll-out of electronic product information (ePI) for human medicines across the EU medicines regulatory network. The ePI initiative will improve the timely delivery of up-to-date, accurate and accessible information on EU medicines to patients and healthcare professionals.
Once the new EU pharmaceutical legislation enters into application, ePI will become mandatory for all newly authorised medicines. The roadmap will be communicated to stakeholders and published on the EMA website in the coming weeks.
EMA’s report on stakeholder engagement over the last two years was presented to the Board. The report describes activities involving the Agency’s key stakeholder groups, including patient and consumer organisations, healthcare professional organisations, academia and EU industry organisations.
Throughout 2024 and 2025, stakeholders continued to contribute to the Agency’s core business of evaluating medicines and monitoring their safety. In addition, stakeholders have contributed to shaping the future of the European pharmaceutical environment by taking part in several initiatives including the European Medicines Agencies Network Strategy to 2028, the ethical and effective use of artificial intelligence and digitalisation tools, and the reflection paper on patient experience data. Engagement with academia and industry was also reinforced through dedicated platforms and strategic dialogue. The report will be published on the EMA website.
The Board adopted EMA’s independence report for 2025, covering how the Agency applied its revised rules for handling of competing interests of scientific committee members, experts, Management Board members, staff and medical device expert panel members in force since May 2025. The report provides facts and figures on controls carried out in 2025 and highlights areas for further improvement in 2026. EMA continues to monitor their impact and ensure independence remains a cornerstone of the Agency’s decision‑making. The report will be published on the EMA website shortly.
The Board heard that EMA, along with the Medicine Shortages Single Point of Contact (SPOC) Working Party, under the governance of Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), is monitoring the impact of the war in the Middle East on the supply of medicines in the EU very closely with a view to identifying appropriate mitigation measures, where necessary.
To date, there are no reports of current critical shortages of medicines, however, companies are reporting various levels of disruptions, mostly related to interruptions to air freight and maritime routes, and rising costs. The situation is highly dynamic, and the risk of shortages may increase if disruptions persist.
The Board noted that the vacancy notice for the next EMA Executive Director was published in the Official Journal of the European Union. The next Executive Director will succeed the current Executive Director, Emer Cooke, whose mandate ends on 30 April 2027. The closing date for applications is 19 March 2026 at 12:00 noon CET. See more details on the process in our info sheet.
The Board was updated on the Biotech Act proposals on clinical trials and on the Commission’s Clinical Research Investment Plan, which complements the ACT EU initiative in supporting a stronger EU clinical trial environment.
ACT EU continues implementation of its priority actions. On 20 March, the initiative will hold its first meeting of 2026 of the Multi Stakeholder Platform Advisory Group. Discussions will include the launch of the call for a new stakeholder co‑chair and the revision of the ACT EU multiannual workplan. In April, the first key performance indicators on clinical trial attractiveness and speed will be published.
In 2026, further modernisation and improvements to the Clinical Trials Information System (CTIS) are planned, including the rollout of a new CTIS safety module in June. Improvement plans for CTIS will also consider the implications of changes foreseen in the proposed Biotech Act.