1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in France in relation to Decentralized Clinical Trials (“DCT”). It supplements the regulations applicable to the EU and EEA described in the European Medicines Agency (“EMA”) guidebook. The provisions of the Clinical Trials Regulation (EU) No 536/2014 (“EU CTR”), which came into effect in January 2022, may be referred to where national legislation does not specifically address issues.

This guidebook focuses on the procedure to be followed for new clinical trial applications submitted from January 2023 in accordance with the EU CTR, supplemented by French laws and regulations, where these are in existence.

Please note that the majority of the primary and secondary sources consulted during the course of research are published in French, and the information contained in this guidebook does not purport to be an official translation of this original material.