Clinical Trials: Launch in France of a “fast-track” accelerated review process starting March 16, 2026

The French National Agency for Medicines and Health Products Safety (ANSM) has announced the implementation of a fast-track evaluation process for clinical trials in France. Starting March 16, 2026, sponsors will be able to submit an eligibility application to benefit from a faster regulatory process for certain early-phase clinical trials.

This initiative aims to reduce the time required to obtain approval for clinical trials, enhance France’s appeal as a destination for international clinical research, and facilitate patients’ access to therapeutic innovations.

A mechanism to expedite clinical trial approvals

The national fast-track program is part of France’s strategy to support clinical research. It was developed by the ANSM in collaboration with several institutional stakeholders, including:

• the National Commission for Research Involving Human Subjects (CNRIPH)

• the National Conference of Committees for the Protection of Persons (CNCP)

• the General Directorate for Healthcare Provision (DGOS)

• the Health Innovation Agency (AIS)

The goal is to simplify and expedite the regulatory review of innovative clinical trials while maintaining scientific, ethical, and regulatory standards.

This initiative also complements the European FAST-EU program, which is designed for multinational clinical trials.

Which clinical trials are eligible for fast-track designation?

The expedited procedure primarily applies to early-stage single-country clinical trials, including:

• Phase I trials

• Integrated Phase I/II trials

To be eligible, the trial must meet at least one of the following criteria:

• relate to a serious, rare, or disabling disease for which there is no appropriate treatment;

• involve an innovative mechanism of action or a new therapeutic class (“first-in-class”);

• Include adolescents (ages 12–18) in a clinical development program.

These trials are governed by European Regulation (EU) No. 536/2014 on clinical trials and may include certain protocols involving drugs and in vitro diagnostic medical devices.

Significantly shorter evaluation times

One of the main benefits of the fast-track process is the significant reduction in regulatory review times.

The scheduled deadlines are as follows:

• 14 days to issue an authorization if no issues are raised during the review;

• A maximum of 49 days when requests for additional information are made.

How can developers submit their applications?

To qualify for the program, developers must follow a multi-step process:

1. Submit an eligibility request to the ANSM using the designated form;

2. Receive a response from the ANSM within 48 hours;

3. If eligible, submit the authorization application through the European CTIS (Clinical Trials Information System) portal;

4. Notify the authorities so that the case can be assigned to a Committee for the Protection of Persons (CPP) participating in the fast-track program.

A pilot program to boost the appeal of clinical research in France

The fast-track program is currently being implemented as a pilot project. Its effectiveness will be evaluated based on:

• the evaluation timeframes achieved,

• the number of clinical trials submitted,

• and developers’ interest in this mechanism.

Ultimately, this initiative could help strengthen France’s competitiveness in the field of clinical research by speeding up the evaluation of trials involving therapeutic innovations.

For more information: https://ansm.sante.fr/news/fast-track-process-for-clinical-trials-in-france-sponsors-will-be-able-to-submit-their-applications-as-early-as-march-16, 2026