On 27 November 2025, a large number of National Competent Authorities (NCAs) and Ethics Committees committed to test a coordinated fast-track approach for evaluating multinational clinical trials.
- This approach, known as FAST-EU (Facilitating and Accelerating Strategic Trials), is part of the overall EU drive to strengthen clinical research in Europe.
- It is coordinated with the European Commission’s upcoming legislative initiative to streamline procedures for multi-national clinical trials in the EU
About the FAST-EU (Facilitating and Accelerating Strategic Trials) initiative
- The FAST-EU approach foresees clear and ambitious timelines and coordination mechanisms.
- The goal is to provide trial sponsors with greater predictability in evaluation and authorisation timelines, strengthen sponsors’ confidence in the European regulatory system and facilitate the attraction of research investment while maintaining scientific, safety and ethical standards.
When is the FAST-EU initiative expected to start?
- The initiative is expected to start in January 2026, and will be part of the wider efforts to enhance collaboration and reliance between national medicines authorities, with the support of the EU.
What does the FAST-EU initiative aim to demonstrate?
- The FAST-EU initiative aims to demonstrate the EU’s capacity for coordination and rapid response, reinforce Europe’s global competitiveness in biomedical research, and ensure that European patients benefit sooner from scientific advancements and therapeutic innovation.
- It also sends a clear signal of commitment to innovation and cooperation within and across member states.
- In contrast to other regions in the world, Ethics Committee opinions of all participating member states are already built into this ambitious process.
Multinational clinical trials in Europe
- Multinational clinical trials account for a significant share of authorised studies in Europe.
- These studies are important, as they enable a sufficient number of patients to be recruited across different countries to obtain robust results and accelerate the development of innovative treatments.
- Facilitating clinical trials in Europe also guarantees the inclusion and representation of European patients in the development of these therapies.
Further details will be communicated through HMA channels in due course.
Source: HMA