Implementation of a Fast-Track Procedure: Accelerating Clinical Trial Authorisations from 2026

From the first quarter of 2026, a new national fast-track authorisation scheme will be implemented to strengthen the attractiveness of France as a research hub and to provide patients with faster and more secure access to therapeutic innovations.

The speed at which clinical trials are authorised and implemented has become a major competitiveness factor in attracting research projects. The numerous administrative delays observed so far have placed Europe—and France in particular—behind other geographical areas, even as the continent seeks to strengthen its scientific and medical leadership.

The fast-track scheme therefore aims to significantly reduce ANSM evaluation timelines, while maintaining high standards of safety and scientific rigour. It is intended for both academic and industrial sponsors.

To this end, the scheme applies exclusively to mono-national clinical trials and is primarily intended for:

Early-phase trials:

• Phase I
• Integrated Phase I/II

Trials meeting at least one of the following criteria:

• Conducted in the context of a serious, rare or disabling disease for which no appropriate treatment is available;
• Involving a first-in-class innovation, i.e. a treatment based on a completely new mechanism of action;
• Promoting the inclusion of adolescents in adult trials, thereby facilitating paediatric research.
  

Eligibility requirements

To benefit from this scheme, sponsors must:

• Meet the eligibility conditions, particularly with regard to the type of trial, the disease studied, the mechanism of action involved and the possible inclusion of adolescents;
• Obtain validation from the ANSM confirming the eligibility of the clinical trial;
• Submit their application via the CTIS portal;
• Provide a complete and compliant dossier in order to avoid additional questions likely to extend the timelines.

Prior eligibility verification will be carried out by the ANSM before the project evaluation process is initiated.

New timelines, in the absence of ANSM questions

The European procedure provides timelines of 31 days with no questions and up to 106 days in case of clarification requests, with an additional 50 days for advanced therapy medicinal products. The French fast-track reduces these timelines to 14 days with no questions, a maximum of 49 days with clarifications, and no additional time for ATMPs.

A pilot phase will be launched upstream to test the system and optimise processes before full deployment in 2026.

However, this accelerated authorisation process does not exempt sponsors from complying with the usual regulatory requirements, namely obtaining:

• A favourable opinion from the ANSM on the scientific, methodological and regulatory aspects of the protocol;
• An opinion from the competent Research Ethics Committee (CPP) concerning ethics and the protection of participants’ rights.
  

Conclusion

The launch of the fast-track procedure in 2026 represents a major step forward for French clinical research. By significantly reducing authorisation timelines, France aims to strengthen its international attractiveness in biomedical research, increase the number of early-phase trials, and improve patient access to the most recent treatments.

Sources:
ANSM – France commits to a fast-track scheme to accelerate clinical trial authorisations

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