‘Fast track’: France’s new accelerated clinical trial authorisation pilot initiative launches
On 16 March 2026, the French medicines agency ANSM launched a new Fast Track pilot procedure to accelerate authorisations for clinical trials of medicinal products conducted in France.
In a context of strong international competition, the initiative aims to speed up approvals, attract more trials to France, and provide patients with faster access to innovative therapies.
Under EU Clinical Trials Regulation 536/2014, applications must be submitted through the CTIS portal and undergo a dual assessment:
- scientific/regulatory evaluation by ANSM,
- ethical review by an ethics committee.
The Fast Track applies to trials meeting at least one criterion:
- serious, rare or debilitating conditions with no adequate treatment,
- first trial in a therapeutic class with a new mechanism of action,
- inclusion of adolescents in an adult‑focused study.
Target approval timelines:
- 14 days when no issues arise (down from 31),
- 49 days if questions are raised (down from 106),
- For ATMPs, a maximum of 62 days.
This French initiative anticipates the upcoming FAST‑EU European programme, aiming for a 70‑day overall assessment timeline for multinational trials.
Full articule on unyer's website.