12/01/2025  |  Mikael Salmela/Joséphine Pour/Léanne Fortuna  |  Hogan Lovells

https://www.hoganlovells.com/en/publications/france-introduces-a-fasttrack-scheme-for-the-authorisation-of-certain-clinical-trials 

France will introduce in 2026 a “fast-track” pathway aimed at accelerating the authorisation of certain mono-national clinical trials. Reserved in particular for early-phase studies, serious diseases without available treatment, first-in-class trials and the trials including adolescents, the ANSM may grant approval within 14 days (no questions) or 49 days (with questions). Prior to the official submission of on the European CTIS, sponsors must obtain, from the ANSM an eligibility confirmation that their trial meets the fast-track criteria. However, this procedure does not entail any exemption to the applicable scientific and ethical requirements.

France introduces a fast-track authorisation pathway for clinical trials
In a press release published on 20 November 2025, the ANSM announced the introduction, as of the first quarter of 2026, of a national accelerated authorisation pathway (“fast-track”) applicable to certain clinical trials conducted on French territory. This initiative forms part of the “France 2030” plan and reflects the intention to strengthen France’s attractiveness for clinical research.

A procedure limited to mono-national clinical trials and meeting specific criteria
The fast track applies solely to mono-national clinical trials, meaning those conducted exclusively in France, and meeting one of the following criteria:

• being in an early-phase trial (phase I or integrated phase I/II); or
• meeting one of the following conditions:
  • concerning a serious, rare or disabling disease for which no appropriate treatment is available;
  • a “first-in-class” trial exploring an entirely new mechanism of action; and/or
  • enabling the inclusion of adolescents in a study initially designed for adults.
  • Eligibility is verified by the ANSM prior to submission of the application through the European Clinical Trial Information System (CTIS).

Shortened timelines, subject to the absence of questions from the ANSM
For applications included in this accelerated pathway:

• where no questions are raised following the assessment, authorisation may be granted within 14 days, compared with the current standard timeline of 31 days;
• where questions are raised, the maximum timeline is set at 49 days, compared with the current standard of 106 days for applications subject to questions.

No additional timeline would be required for the review of an advanced therapy medicinal product, for which timelines are usually extended. The fast-track procedure would therefore also be completed within a timeframe of 14 to 31 days.

The fast track will initially be implemented in the form of a pilot phase.

This acceleration of the authorization process does not exempt sponsors from complying with the regulatory requirements that are usually applicable, as follows:

1. the favourable opinion of the ANSM on the scientific, methodological and regulatory aspects of the protocol; and
2. the opinion of the competent ethics committee (Comité de protection des personnes – CPP) on ethical issues and the rights of the individuals concerned.

Legal and strategic implications of this new procedure
The fast-track pathway addresses several legal and strategic implications:

• Accelerated access to innovation. The significant reduction in authorization delays aims to give patients priority access to experimental treatments offering major therapeutic benefits, particularly for serious conditions or those with no alternative treatments.
• Improved attractiveness for clinical research. Shorter delays are a competitive advantage for sponsors, industrial or academic, wishing to conduct their trials in France.
• Maintenance of safety requirements. ANSM emphasizes that this acceleration does not compromise the level of rigor expected for applications, ensuring scientific quality and participant safety.

What will be the obligations upon sponsors?
To benefit from this pathway, sponsors must:

• comply with the eligibility conditions (type of trial, disease area, novel mechanism, adolescent inclusion);
• obtain ANSM validation of the eligibility of their clinical trial;
• submit their application through CTIS portal;
• provide a complete and compliant dossier upfront, notably to avoid questions that would extend the timeline;
• cooperate with the authorities and respond promptly to any requests for additional information.

The “fast-track” pathway announced by the ANSM constitutes a significant improvement of the clinical trial authorisation process in France, as it halves the timelines while maintaining the legal requirements of safety and ethics. Its implementation could strengthen France’s position in international clinical research, provided that the stakeholders are prepared to engage in an accelerated and rigorous process.

However, this improvement pertains only to the ANSM’s authorisation procedure. Sponsors must remain attentive to the timelines required, where applicable, by other authorities when additional steps are necessary depending on the type of trial concerned. For example, for clinical trials whose characteristics do not allow compliance with Reference Methodology 001, sponsors must anticipate a 4-month timeline before the CNIL to obtain authorisation to collect and process health data. In the absence of adoption of the draft law on simplifying the economic environment, in cases involving the collection of biological samples requiring export, or the import of samples for the purposes of the clinical trial, sponsors must expect a 3-month wait to obtain authorisation from the Ministry of Higher Education and Research.

This development therefore represents a major step forward, but one can only hope that accelerations or simplifications will also be introduced at the level of the other authorities involved in the implementation of a clinical trial in France.

Next Steps
The details of the pilot phase have not yet been communicated and will provide greater clarity on the practical steps sponsors will need to complete in order to benefit from this procedure. Our specialised team remains at your disposal for any questions you may have on this matter.