The European Medicines Agency (EMA) Management Board, at its 12 March 2026 meeting, reviewed the agency's 2025 performance and approved the 2026 work programme, which prioritises implementation of the revised EU pharmaceutical legislation and expansion of the EMA's role in health emergencies, according to minutes published on 4 May 2026.
The Board, chaired by EMA Management Board Chairperson Emer Cooke, noted that in 2025 the EMA approved 78 new active substances and successfully rolled out the European Medicines Verification System. The Board endorsed the 2025 annual report and noted a 95% budget execution rate. For 2026, the work programme also prioritises the new Health Technology Assessment Regulation and the digital transformation of regulatory processes.
Pharmaceutical legislation revision A key discussion point was the revision of the EU pharmaceutical legislation. The Board received an update on the legislative process and stressed the need for adequate resources to support the transition to the new regulatory framework, which aims to foster innovation while ensuring access to affordable medicines. The minutes note that the European Parliament and Council are expected to reach a final agreement by end of 2026.
Digital strategy and cybersecurity The Board discussed the agency's digital strategy, including the development of a common data platform for regulatory submissions under the EU's Digital Europe Programme. The project aims to streamline data sharing between national competent authorities and the EMA. The Board welcomed progress but called for stronger cybersecurity measures.
Medicine shortages coordination On medicine shortages, the Board reviewed the performance of the EU's Single Point of Contact system, which has improved early detection of supply disruptions. However, the Board noted that national authorities still face challenges in coordinating responses and called for enhanced cross-border cooperation.
Stakeholder impact The revised pharmaceutical legislation will affect pharmaceutical companies, which may face higher compliance costs but also benefit from streamlined approval processes. Patients and healthcare providers stand to gain from faster access to innovative therapies. National regulatory authorities will need to adapt to new coordination requirements, while the EMA itself will require additional resources to manage its expanded mandate.
Next steps The EMA will publish its 2025 annual report in June 2026. The Board's next meeting is scheduled for 16 June 2026, where it will discuss the mid-year budget review and progress on the digital strategy.
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