As of early 2026, France enters a new phase in clinical-research competitiveness with the roll-out of a national “fast-track” authorization pathway for certain clinical trials. Announced on 20 November 2025 by the ANSM together with key health authorities, this mechanism aims to drastically shorten approval timelines - while preserving the highest standards of safety and scientific quality.
What is the French Fast-Track Pathway ?
The new fast-track applies to mononational trials (i.e., conducted only in France), starting with early-phase (phase I or integrated I/II).
Eligibility is limited to trials that meet at least one of the following criteria:
- Investigate a serious, rare or disabling disease with no appropriate existing treatment,
- Target a first-in-class therapy (i.e., a treatment with a novel mechanism of action),
- Include adolescents in trials designed for adults, where scientifically and ethically justified.
Before formal submission via the European portal CTIS (Clinical Trial Information System), sponsors benefit from a pre-submission eligibility check by ANSM to ensure that the trial qualifies for fast-track processing.
Authorization Timelines: What Changes ?
Here is a comparison between the standard process under the European framework and the new French fast-track:
| Situation | Standard timeline | Fast-Track timeline (if eligible) |
|---|---|---|
| Dossier clean (no question) | 31 days | 14 days |
| Dossier with questions / need for clarifications | Up to 106 days | Up to 49 days max |
| Innovative therapies / ATMP (when additional delay applied) | + up to 50 days | No additional delay in fast-track |
This represents roughly a halving of the minimal authorization time, and a major acceleration even when questions arise.
Safety, Ethics and Quality - No Compromise
The fast-track is not about “fast but lax.” The procedure remains grounded in the rigorous, dual-evaluation framework defined by the European regulation:
- The ANSM reviews all scientific, methodological and regulatory aspects of the protocol.
- A separate independent ethics committee — a CPP (Comité de Protection des Personnes) - assesses ethical compliance.
The agencies underline that participant safety and scientific quality remain non-negotiable. The acceleration results from optimization of interactions and processes, not from lowering standards.
Why This Matters for Sponsors, Biotechs and Patients
- Faster trial start → shorter time to first patient in, accelerating the development timeline.
- Greater predictability: sponsors can better forecast their development plan and allocate resources.
- Enhanced attractiveness of France: by reducing regulatory friction, France becomes more competitive internationally for early-phase and high-innovation trials.
- Focus on unmet needs: the eligibility criteria privilege rare diseases, first-in-class therapies and adolescents inclusion - areas where innovation is most needed.
- Support for innovation ecosystem: this can encourage more academic and biotech-led projects, reinvigorating the national clinical-research landscape under the umbrella of the broader France 2030 plan.
A Strategic, Forward-Looking Signal from France
By launching this fast-track scheme, France sends a clear message: it wants to remain at the forefront of clinical innovation. For sponsors navigating a complex regulatory environment in Europe — especially in early-phase, first-in-class or rare-disease development — this new pathway offers a strategic advantage: accelerated access, maintained quality, and high regulatory reliability.
Sources: ANSM
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