On 16 March 2026, France’s National Agency for the Safety of Medicines and Health Products (“ANSM”) launched a pilot fast-track procedure for the authorisation of clinical trials on medicinal products for human use (”MPHU”) that are carried out in France.

As highlighted by the ANSM, against a backdrop of fierce international competition in clinical research on MPHU, the speed of authorisation and the start of clinical trials for MPHU is a major strategic challenge. Therefore, the fast-track initiative’s aim is to attract more of such projects to France with the goal of offering patients earlier access to innovative therapies.

Since 31 January 2022, the EU Clinical Trials regulation (regulation 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use) has governed the conduct of clinical trials on MPHU. In terms of administrative handling, all authorisation applications must be submitted via the Clinical Trial Information System (“CTIS”) portal, which centralises all applications to competent authorities within the European Union.

However, in substance, authorisation of a clinical trial remains subject to a dual assessment. In France, the ANSM assesses the scientific, methodological and regulatory aspects of the trial protocol, whilst an ethics committee (or comité de protection des personnes) examines its ethical basis.

Only if both assessments are positive can administrative authorisation to conduct the trial be granted.

In terms of shortening processing times, the ANSM states that the pilot fast-track procedure will offer academic and industrial sponsors an accelerated pathway for approval of clinical trials conducted in France and falling under the EU Clinical Trials regulation – or those combining trials involving MPHU and in vitro diagnostic medical devices –  which meet at least one of the following criteria:

• • The trail concerns a serious, rare or debilitating disease for which no appropriate treatment is currently available;
  • It is the first trial in a therapeutic class with a completely new mechanism of action; and/or
  • It involves the inclusion of adolescents in a clinical trial centred on adults.

In terms of the CTIS application procedure, the fast-track initiative will involve the ANSM verifying the trial’s eligibility prior to submission via the CTIS portal, with the ANSM undertaking to provide a response within 48 hours.

Once the clinical trial application has been submitted via the CTIS portal, the ANSM has indicated that, where the sponsor’s application raises no issues following the ANSM’s and the ethics committee’s assessments, the authorisation timeframe under the fast-track initiative will be capped at 14 days.

This promises to cut in half the 31-days assessment timeframe set out under the EU Clinical Trials regulation.

Where the clinical trial application raises issues following the ANSM’s and the ethics committee’s assessments, the fast-track authorisation timeframe will be extended to a maximum of 49 days, in comparison to 106 days under the EU Clinical Trials regulation.

Finally, as concerns advanced therapy medicinal products (“ATMP”), an additional assessment period of up to 50 days applies under the current procedure. While the ANSM initially indicated that no extended evaluation period would apply to ATMP, its Advice to Applicants, also released this month, mentions a maximum timeframe of 62 days.

The ANSM’s pilot will be closely monitored by pharmaceutical companies who have long highlighted the long delays in obtaining clinical trial authorisation.

To give but one example, Leem, the association for pharmaceutical companies operating in France, has recently cited the drastic difference in wait times for new treatments to reach patients in France compared to other EU countries with the result that “Procedures are taking longer, innovations are on hold, and so are patients”.[1]

The French initiative has launched in advance of the European Heads of Medicines Agencies FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) pilot programme, which promises to offer an accelerated assessment of multinational clinical trial applications in advance of the arrival of the new Eu regulation of so-called EU Biotech Act.

The FAST-EU sponsor’s guide published on 21 January 2026 states that FAST-EU aims for an overall duration of 70 calendar days from CTIS submission to conclusion of the clinical trial application, including sponsor response times.

Sponsors have been able to express their interest in taking part in FAST-EU since 30 January 2026, although no launch date has been announced.

[1] Make France a European leader in healthcare innovation, 17 November 2025 (La France à l’Heure des choix – Accélérons l’accès au progrès thérapeutique ! | Leem).