European initiative accelerates authorization of multinational clinical trials
28 nov 2025
The Heads of Medicines Agencies (HMA), of which INFARMED – the National Authority for Medicines and Health Products, I.P. – is a member, has launched an accelerated assessment procedure for multinational clinical trials, unprecedented in Europe.
An announcement published on the HMA website describes the FAST-EU (Facilitating and Accelerating Strategic Trials) project as a response to the needs of the sponsors for this type of studies: to increase the predictability of evaluation and authorization timelines, in order to strengthen sponsors’ confidence in the European regulatory system and attract more research to the European space, while maintaining scientific, safety and ethical standards.
This initiative also represents a clear benefit for European patients, by allowing an earlier access of innovative therapies in the clinical investigation phase and ensuring that the European population is properly represented in the data that supports future authorizations.
FAST-EU is part of the European Union effort to strengthen clinical research, and is aligned with the European Commission's upcoming legislative initiative aiming to simplify procedures applicable to multinational clinical trials.
The approach sets clear and ambitious timelines and strengths coordination mechanisms between Member State National Authorities and Ethics Committees. The initiative is expected to be launched in January 2026.
