France: Navigating Clinical Trial Compliance Before the January 2025 Deadline

On 31 January 2022, European Regulation No. 536/2014 (CER) on clinical trials of medicinal products officially came into force, replacing Directive 2001/20/EC (EC Directive). This marked the beginning of a three-year transition period, during which clinical trial authorizations granted under the EC Directive have remained valid.

However, as of 31 January 2025, any clinical trial that has not transitioned to the CER legal framework will lose its authorization.

The Importance of Compliance

The responsibility of ensuring compliance with the new regulation rests squarely on clinical trial sponsors. In France, ANSM has stated any clinical trial involving a medicinal product or an advanced therapy medicinal product authorized under the EC Directive and with at least one active site on French territory as of 31 January 2025, is subject to this transition requirement.

ANSM has actively raised awareness among sponsors about the implications of the new legal framework. Sponsors are urged to initiate the transition of their trials to the CER framework promptly, considering the time needed for application reviews.

The Transition Process

Sponsors must apply for transition authorization through the Clinical Trials Information System (CTIS). This process does not involve a new assessment, as the documentation used for the original trial authorization is already accessible to competent authorities.

However, non-compliance carries significant risks. According to the European Commission, sponsors who fail to transition their clinical trials by 31 January 2025, deadline could face corrective measures, potentially halting their trials and restricting the use of associated data by sponsors and investigators. ANSM also has set an earlier cut-off which sponsors are required to confirm their intent to transition by 16 December 2024, to avoid these measures.

As of 31 January 2025, the deadline approaches, and the urgency for sponsors to transition their clinical trials to the CER framework cannot be overstated. The harmonized processes under the CER not only ensure regulatory compliance but also drive advancements in patient care and clinical research across Europe.

Sponsors must act decisively to meet the transition requirements, safeguarding the continuity of their trials and the valuable data they generate.

Source: French National Agency for Medicines and Health Product Safety (ANSM)