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The French Fast-Track is an accelerated regulatory pathway designed to shorten approval timelines for eligible Phase I and integrated Phase I/II clinical trials conducted in France.
By reducing assessment timelines while maintaining rigorous scientific and ethical standards, it helps sponsors bring innovative therapies into clinical development faster.
The programme is managed by the French regulatory authority, ANSM, which assesses eligibility requests and oversees the fast-track review process.
Eurofins Optimed supports sponsors throughout the Fast-Track application process and the conduct of early-phase clinical trials in France.
From regulatory strategy and submission support to clinical trial execution in our dedicated Phase I unit, our experts help you maximise the benefits of this accelerated pathway and keep your development programme on track.