EMA Management Board: highlights of December 2025 meeting

24th December 2025

EMA Management Board: highlights of December 2025 meeting

Summary: At its December 2025 meeting (highlights published 19th December 2025), the EMA Management Board welcomed the political agreement on the new EU pharmaceutical legislation, describing it as a major milestone for EU medicines regulation and patients. The Board adopted EMA’s 2026 work programme, with a strong focus on preparing for the legislative changes, supporting innovation, and investing in network capability — including digitalisation and artificial intelligence. It also approved EMA’s 2026 budget (a 2.6% increase to over €615 million) and adopted programming documents covering 2026–2028 and the preliminary plan for 2027–2029. 

A key outcome was agreement on a new governance structure to oversee implementation of the pharmaceutical legislation, including a cross-workstream group spanning centralised procedures and committees, development support, environmental risks, quality/manufacturing, medicines shortages and legal aspects — with civil society (patients and healthcare professionals) included in two workstreams. The Board also discussed other upcoming legislation affecting EMA’s role, including proposed revisions to the Medical Device and IVD Regulations (new responsibilities around expert panels and reporting supply disruptions), and noted the European Commission’s proposed Biotech Act, which includes amendments to the EU Clinical Trials Regulation. 

The Board received updates on key operational priorities: future tendering to extend DARWIN EU (real-world evidence network) beyond 2027, rollout of data and AI training across the EU network in early 2026, progress on CTIS (nearly 13,000 applications since 2022, with over 10,600 trials authorised), and adoption of EMA’s Technology Capability Investment Plan to 2028 to support a more digital, data-driven regulatory network. 

Link: EMA Management Board: highlights of December 2025 meeting

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