The Management Board adopted EMA’s work programme for 2025, which outlines how the Agency will adapt to the rapidly evolving medicines landscape and prepare for the transition to the European Medicines Agencies Network Strategy (EMANS), which is currently being updated to 2028. Key drivers include an ever-growing product portfolio, the new European Commission’s priorities with an increasing focus on managing medicines shortages, as well as the application of the EU Health Technology Assessment (HTA) Regulation and the entry into force of the New fee regulation in January 2025.
In 2025, the Agency will maintain its focus on accelerating and optimising the assessment of key medicines, improving both accessibility and availability of medicines, as well as working on the approach to future-proofing medicines regulation in the EU in preparation for the new pharmaceutical legislation.
The final programming document for 2025-2027 was adopted and will be published on EMA’s website towards the end of January 2025. The Board also adopted the preliminary programming document for 2026-2028.
The Board adopted the Agency’s budget for 2025, which increased by almost 24% compared to 2024, to a total of over 600 million euros, as a result of the New fee regulation which enters into force on 1 January 2025, and the growing activities of the network. The New fee regulation provides a sound financial basis to support the operations of the European medicines regulatory network, as well as the objectives outlined in the EMANS to 2028.
The Board noted that EMA’s processes and systems are on track for the coming into effect of the New fee regulation. It adopted revised working arrangements between EMA and the Member States which will be published on the EMA website shortly. A new webpage with an overview of information for stakeholders related to the Regulation is available.
The Board adopted EMA’s revised policy on handling of competing interests of scientific committee members and experts (‘Policy 0044’). Following endorsement of the draft revision of the policy by the Board in October 2024, a public consultation on the draft revised policy ran from 10 October to 10 November 2024. After review and due consideration of comments received, no major changes to the policy’s principles are proposed. Clarifications have been made, in particular to some definitions. The final policy, as well as a high-level overview of the contributions received during the consultation and how comments have been addressed by EMA, will be published on the EMA website with a news announcement in January 2025.
EMA’s policy on handling competing interests of Management Board members (‘Policy 0058’) has also been revised to align, where needed, with Policy 0044, including on rules to handle interests from Management Board members related to involvement with or affiliation to a research organisation. The new policies will become effective in May 2025.
At the end of a busy year of work on shortages for EMA and the European medicines regulatory network, the Board heard that the European Shortages Monitoring Platform (ESMP) has now gone live with a core set of functionalities. This digital platform is an important deliverable of the Agency’s extended mandate, enabling the quick and efficient exchange of information between regulators and pharmaceutical companies on shortages of medicines. It is also a major milestone in the effort to tackle medicine shortages and ensure that medicines are available to patients when and where they need them most.
The Board adopted an updated version of the Union list of critical medicines, which was first published in December 2023. The latest version contains 270 actives substances of medicines for human use. It is a key tool to support the EU’s efforts to prevent shortages and safeguard the supply of medicines for which a shortage could cause significant harm to patients and pose challenges to health systems. The list, which will be updated annually, will be published on EMA’s website shortly, with a revised questions-and-answers document.
The Board thanked the HMA/EMA Taskforce on Availability of Medicines (TF-AAM) for their pioneering work that built the foundations for EU cooperation on medicine shortages. Set up voluntarily by the Member States and EMA in 2016, at a time when the Agency had no formal responsibilities regarding shortages of medicines, the Taskforce will now be dissolved and its activities transferred to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and the Medicines Shortages Single Point of Contact (SPOC) Working Party.
The Board heard updates from the European Commission and EMA on the upcoming application of the EU Health Technology Assessment (HTA) Regulation, set to take effect on 12 January 2025.
EMA presented highlights of its implementation activities at the intersection of regulatory processes and HTA assessment. The Board noted the Agency’s first experiences with the new parallel notification by companies which intend to submit a marketing authorisation application for regulatory assessment by EMA and for joint clinical assessment by EU-HTA bodies under the new HTA Regulation. The collaborative work at this intersection is covered by the new legal framework for exchanging confidential information with the new HTA structure.
The Board endorsed step two of the relaunch of EMA’s clinical data publication. Clinical data underpinning initial marketing authorisation applications, extensions of therapeutic indications and line extensions will be published on the Agency’s clinical data website, starting with opinions adopted by the Agency’s human medicines committee (CHMP) from May 2025.
Clinical data for medicines that were approved while EMA’s policy was suspended can be requested via a standard webform to EMA. Requests for these clinical data packages will then be processed by EMA and published on its clinical data website.
Step one of the re-launch started in September 2023 with non-COVID medicines with a new active substance (initial marketing authorisation applications only).
The Board was updated on ACT EU, the initiative jointly led by Member States, European Commission and EMA to strengthen clinical trials in the EU. Ten thousand clinical trial applications have been submitted in the Clinical Trials Information System (CTIS) since January 2022. The Board acknowledged the efforts to encourage the transition of all ongoing clinical trials to CTIS by 30 January 2025. This marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable. The priority going forward is to continue to strengthen the clinical trial environment. Feedback from stakeholders will be reflected in the upcoming revision of the Accelerating Clinical Trials in the EU (ACT EU) workplan.