National Competent Authorities and Ethics Committees across the EU/EEA have agreed to test a new coordinated fast-track process for the assessment of multi-national clinical trials. The initiative, called FAST-EU (Facilitating and Accelerating Strategic Trials), aims to make clinical research in Europe more efficient and attractive for sponsors.

Indeed, FAST-EU introduces clear timelines and stronger coordination, helping build confidence in the European regulatory system while maintaining high scientific, ethical and safety standards.

The pilot will start in January 2026 and supports broader EU efforts to enhance cooperation and reliance between national medicines authorities. A key element is the early and coordinated involvement of Ethics Committees from all participating Member States, ensuring robust ethical oversight within an accelerated process.

Multi-national clinical trials are essential for generating reliable evidence and enabling European patients to benefit sooner from innovative treatments. By simplifying and accelerating trial evaluation, FAST-EU reinforces Europe’s commitment to research, innovation and timely patient access to new medicines.

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