Accelerating the authorization of clinical trials in Europe and France
February 3, 2026
Clinical research is regulated by stringent procedures to ensure the rigorous evaluation of healthcare innovations and the safety, well-being and rights of participants. These essential requirements inevitably contribute to the time needed to assess clinical trial applications. However, new measures will be put in place to speed up these procedures, while upholding the high standards of quality, safety, and ethics.
FAST-EU: A new fast-track procedure for the evaluation of multinational clinical trials in Europe
The National Competent Authorities (NCAs) and Ethics Committees of the European Union and European Economic Area (EU/EEA) have agreed to test a coordinated fast-track approach for the evaluation and authorization of multinational clinical trials. This initiative, known as FAST-EU (Facilitating and Accelerating Strategic Trials), aims to improve the predictability, coordination and efficiency of regulatory timelines.
FAST-EU has just been launched! FAST-EU aligns with upcoming European Commission legislative initiatives designed to streamline procedures for multinational clinical trials. It aims to strengthen collaborations between national medicines authorities, increase Europe’s global competitiveness in clinical research, attract research investment, and enable patients to gain faster access to therapeutic innovations.
Fast-track authorization for some mononational clinical trials in France
In parallel with this European initiative, France will pilot a national fast-track authorization system, starting in the first quarter of 2026, to accelerate the authorization of some mononational clinical trials.
For further details regarding eligible clinical trials and new authorization timelines, consult the website of the French National Agency for the Safety of Medicines and Health Products (ANSM): https://ansm.sante.fr/actualites/la-france-sengage-avec-un-dispositif-fast-track-pour-accelerer-les-autorisations-dessais-cliniques
Santé Active Edition – Synergy Pharm: a clinical research partner
Our experienced medical writing team supports clients throughout the clinical research process by preparing the regulatory and clinical documentation required by health authorities before and after a clinical study.
Our medical writers also contribute to the dissemination of clinical research results by writing publications for peer-reviewed journals (original articles, literature reviews, etc.) and by preparing various communication materials for conferences and meetings (abstracts, posters, slides, proceedings, etc.), as well as resources intended for the general public. Indeed, sharing knowledge with the scientific community, healthcare professionals and patients is essential for promoting transparency, supporting the exchange of lessons learned from trials, and driving progress in research, all of which facilitate the development of new therapeutic approaches and improvements in clinical practice.
Do not hesitate to contact us to discuss your projects!