European Commission, EMA and HMA set ambitious new targets to boost EU clinical trials and patient access to innovative medicines

European Commission, EMA and HMA set ambitious new targets to boost EU clinical trials and patient access to innovative medicines

(IN BRIEF) The European Commission, EMA, and HMA have set new targets to strengthen Europe’s role in clinical research by authorising an additional 500 multinational clinical trials over five years and ensuring that two-thirds of studies begin patient recruitment within 200 days. These goals are part of the ACT EU initiative, which promotes innovation, efficiency, and collaboration in clinical research. Complementary programmes, such as CTR Collaborate, COMBINE, and MedEthicsEU, are designed to streamline procedures, harmonise ethics processes, and integrate regulatory frameworks. A new report reviewing the first three years of the Clinical Trials Regulation shows that around 200 new applications were submitted monthly, including 80 multinational trials, despite the challenges of transition to the CTIS system. With the CTR and CTIS now fully in place, Europe has a stronger foundation for timely, high-quality clinical research.

(PRESS RELEASE) AMSTERDAM, 24-Sep-2025 — /EuropaWire/ — The European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have announced new targets to expand and accelerate clinical trials across the European Union, with the goal of making Europe a more competitive and attractive hub for medical research.

Over the next five years, the EU aims to authorise an additional 500 multinational clinical trials, adding about 100 new approvals each year to the current average of 900. In parallel, it has set an efficiency target to ensure that two-thirds of all clinical trials begin patient recruitment within 200 days of application submission, a marked improvement from the current 50% rate.

These objectives build on the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched jointly by the EC, HMA, and EMA to streamline trial design, strengthen oversight, and improve access for patients to innovative medicines. ACT EU brings together regulators, industry, and patient groups to co-create solutions for clinical trial challenges. Among its priorities are a trial map to connect patients with ongoing studies, new pilot schemes offering advice to trial sponsors, guidance to implement the revised Good Clinical Practice guideline (ICH E6 R3), and support for non-commercial sponsors to run multinational studies.

The broader European regulatory network is also rolling out complementary programmes to support the new targets. The CTR Collaborate initiative encourages national authorities and ethics committees to harmonise procedures and reduce administrative complexity. The COMBINE programme is piloting a single, streamlined process to align the separate frameworks for medicinal products, medical devices, and in-vitro diagnostics. In addition, the MedEthicsEU forum has been established by the European Commission to foster dialogue and knowledge-sharing among ethics committees across EU and EEA Member States.

Progress on these targets will be monitored closely, with updates published monthly on the ACT EU website starting February 2026.

The announcement coincides with the release of a new EU clinical trials report reviewing the first three years of the Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS), which became mandatory in January 2022. The analysis shows that an average of 200 new clinical trial applications were submitted monthly over the transition period, with about 80 of these for multinational studies. While sponsors and regulators were adapting to new legal requirements during this phase, the CTR and CTIS are now fully implemented, providing a solid foundation for a more transparent, efficient, and collaborative clinical trial ecosystem in Europe.

The EMA will host a LinkedIn Live session on 24 September to discuss the new clinical trial targets. Speakers include Marianne Lunzer, Clinical Trials Assessor at the Austrian Agency for Health and Food Safety; Corinna Hartung, Policy Officer at the European Commission; and Ana Zanoletty, Head of the Clinical Trials Transformation workstream.

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SOURCE: European Medicines Agency