Insights

On 26 November 2025, several National Competent Authorities (NCAs) and Ethics Committees across the EU/EEA announced the launch of a coordinated fast-track approach for evaluating multinational clinical trials, named FAST-EU (Facilitating and Accelerating Strategic Trials).

This significant initiative is part of the EU’s broader strategy to strengthen clinical research in Europe. It is aligned with the European Commission’s forthcoming legislative proposal to streamline procedures for multinational trials and is designed to offer greater predictability, efficiency, and collaboration in the clinical trial authorization process.

FAST-EU sets clear and ambitious timelines, with enhanced coordination mechanisms among NCAs and Ethics Committees. By improving regulatory reliability and reducing administrative barriers, the model aims to attract more research investment, foster innovation, and ensure European patients gain timely access to cutting-edge treatments.

The initiative will officially begin in January 2026 and plays a central role in bolstering Europe's position in global biomedical research. It reinforces the EU's commitment to high scientific, safety, and ethical standards while supporting patient inclusion and accelerating development timelines.

RPN will provide any further update and is available to provide full regulatory support for Clinical Trials.