EMA Management Board: highlights of December 2025 meeting

19 December 2025

Board welcomes political agreement on new pharmaceutical legislation and adopts work programme for 2026

The Management Board opened its meeting welcoming the political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the new EU pharmaceutical legislation. The legislation represents a historic milestone for European medicines regulation and for patients across the EU, creating significant opportunities to strengthen Europe’s position as a leader in pharmaceutical innovation.

The Board adopted EMA’s work programme for 2026, which sets out the Agency’s priorities for the coming year. While EMA will continue to ensure the highest standards in the evaluation and supervision of human and veterinary medicines, work during 2026 will focus on intense preparation for the changes introduced by the new EU pharmaceutical legislation, supporting innovation for public and animal health and investing in developing our staff across the European medicines regulatory network. As EMA carries out its work across these three areas, it will seize opportunities to modernise the regulatory system in response to rapid scientific and technological advances, enhancing efficiency through digitalisation and artificial intelligence, while expanding early development support to enable new medicines to be authorised in the EU as rapidly as possible.

The Board adopted the final programming document for 2026-2028 (to be published at the end of January 2026) and the preliminary programming document for 2027-2029. The Agency's budget for 2026 was also adopted, increasing by 2.6% compared to 2025 to over 615 million euros, driven primarily by increased fee income from the growing product portfolio of centrally authorised products.

A governance structure for the implementation of the new pharmaceutical legislation, once adopted

The Board adopted a governance structure to guide and oversee EMA’s implementation of the pharmaceutical legislation and its impact on the network. A new group, including representatives from EMA, the Management Board and the European Commission, will oversee work across workstreams on the centralised procedure and committees, development support, environmental risks, quality and manufacturing, shortages and other regulatory and legal aspects. Both the centralised procedure/committee and development support workstreams will also include civil society representatives (patients and healthcare professionals). This integrated approach aims to ensure close coordination between EMA, the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Coordination Group for Mutual Recognition and Decentralised Procedures (Human) (CMDh), the Commission, the European medicines regulatory network and stakeholders, throughout the implementation of the new legislation.

Other new pieces of legislation

The Commission updated the Board on the proposals for a revision of the Medical Device Regulation ((EU) 2017/745) and the In Vitro Diagnostic Medical Device Regulation ((EU) 2017/746), which assign new responsibilities to EMA regarding the management of medical device expert panels, to work with the Commission to set up and manage an IT system for reporting and sharing information on supply interruptions or discontinuation of critical medical devices, and to provide support to the national competent authorities for medical devices to facilitate the exchange of experience, cooperation and coordination in certain areas. The Board also welcomed the publication of the Commission's proposed Biotech Act, which is designed to further boost biotech innovation and research in the EU and includes several amendments to the EU Clinical Trials Regulation.

Report from chair of EMA's Paediatric Committee

Dr Sabine Scherer, chair of EMA's Paediatric Committee (PDCO), updated the Board on key activities of the PDCO in 2025, emphasising efforts to facilitate the development of paediatric medicines. She noted that the 2007 EU Paediatric Regulation has significantly augmented the development of medicines for children, resulting in an increased range of treatment options. Nevertheless, children remain underrepresented in clinical development, which is still leading to delayed access to innovative treatments and reliance on off-label prescribing.

Dr Scherer also underlined the importance of further strengthening patient and healthcare professional engagement in paediatric drug development to improve program feasibility and implementation success rates. Looking ahead, Dr Scherer noted that the new pharmaceutical legislation may create an even more favourable environment for paediatric medicine development, positioning the EU to drive innovation that will benefit children across the region.

Data and artificial intelligence in medicines regulation

In the first half of 2026, EMA will launch a competitive tender to extend the work of the Data Analysis and Real World Interrogation Network (DARWIN EU) from 2027 to 2032. DARWIN EU provides the infrastructure, data and tools needed to generate relevant and reliable real-world evidence on diseases, populations and medicine performance across Europe through a federated approach. Since its inception in 2022, more than 100 studies have been initiated and 32 data partners have joined, enabling the use of health data from 188 million patients across 16 European countries to answer research questions around the use of medicines.

The Board also noted the recent activities of the network data steering group. The first data strategy for medicines regulation has been published, outlining a clear approach to ensure that the European medicines regulatory network data assets are well-governed, meet high standards of quality and deliver value to stakeholders. In addition, agreement on a proposal for data training, including modules on artificial intelligence, will be rolled out to the network starting in the first quarter of 2026, through the EU Network Training Centre Learning Management System.

Clinical trials in the EU

The Board was updated on progress with clinical trials in the EU. Since its launch in 2022, the Clinical Trial Information System (CTIS) has received nearly 13,000 initial applications, with over 10,600 clinical trials authorised by EU Member States. Future developments, including the amendments to the Clinical Trials Regulation under the European Commission’s proposed Biotech Act will require changes to CTIS, and the Board noted that the planning for modernising CTIS that is underway may need to be reviewed.

The Accelerating Clinical Trials in the EU (ACT EU) initiative continues to support the implementation of the Clinical Trials Regulation and strengthen the clinical research ecosystem, aiming to deliver better, faster and smarter trials across the EU. Under ACT EU, EMA, the EC and HMA have set ambitious targets to enhance the EU’s attractiveness for clinical research and accelerate patient access to innovative medicines. Progress will be monitored from 2026 through an interactive dashboard for the European medicines regulatory network, as well as regular public reports for stakeholders. The objective of ACT-EU to drive faster clinical trial timelines is also supported by the HMA-led FAST-EU initiative.

Technology capability investment plan to 2028

The Board noted EMA’s technology capability investment plan to 2028, which sets the strategic direction for achieving the technology objectives of the network and its stakeholders in the coming years. The plan addresses information management needs arising from strategic requirements as well new pieces of legislation, such as the new pharmaceutical legislation, and supports the development of a fully digital, efficient and data-driven network. The plan will serve as a guideline for EMA’s technology investment and selection and is published on the EMA website.