FAST-EU (Facilitating and Accelerating Strategic clinical Trials in the EU) is a voluntary pilot project supported by the HMA (Head of Medicines Agencies) with a planned duration of one year. It stems from a commitment to innovation and cooperation between different Member States and aims to increase Europe's global competitiveness in biomedical research and ensure that European patients benefit more quickly from scientific developments.

The project envisages an accelerated assessment of multinational clinical trials in the European Union, with a maximum overall timeframe of 70 days from CTIS submission to the conclusion of the trial authorization process, including the sponsor's response time to any requests from the Competent Authorities. 

The parallel validation and assessment workflows, the strengthened role of the RMS, and the integration into the project of the Ethics Committees of all participating Member States aim at increasing the confidence of the industry in the European regulatory system and, by simplifying and accelerating procedures, intend to attract investment in research, while maintaining high scientific, safety and ethical standards.

The project is crucial because, to date, multinational clinical trials account for a very high percentage of all trials authorized in Europe. It is important to ensure that the development of innovative treatments is accelerated and that there are greater inclusion and an effective representation of European patients in the global trials.