France advances towards alignment with EU Clinical Trial Regulation

Eveline Van Keymeulen

On 18 November 2016, Decree No. 2016-1537 concerning research on humans came into force. The Decree implements related Order No. 2016-800 adopted last June to align French rules on clinical trials of medicinal products with the EU Clinical Trials Regulation (Regulation (EU) No. 536/2014), which is expected to enter into force no earlier than 2018.

The decree confirms the competence of the National Agency for Medicines and Health Products Safety (ANSM) for the technical/scientific evaluation of trials on health products. It also establishes the terms and conditions to conduct research on humans, in particular:

  • Definitions on types of research (for example on medical devices, or cosmetics etc.) and provisions concerning research involving genetically modified organisms.

  • Authorisations for first-in-human drug clinical trials, which will be issued for a three-year period by the Regional Health Agencies.

  • Vigilance rules, including sponsor’s insurance obligations, definitions/types of adverse effects and related safety/suspension and reporting obligations on the sponsor/researcher.

  • Operating rules for the National Commission on Research on Humans (mission, composition, functioning and organisation).

  • Operating rules on the intervention, (random) assignment and vigilance role of the ethics committees (Comités de protection des personnes).

  • Rules entitling sponsors to request that the National Insurance Bodies (Caisses d’Assurance Maladie) cover authorised experimental or auxiliary medicines or products subject to the research provided they do not give right for reimbursement, as well as related provisions for dispensing pharmacies.

The decree has been published in parallel with an Executive Decision and Decree which reinforce the mechanism of a single convention simplifying the procedure for commercial research on humans in health facilities and centres.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, November 2016 Issue (Thomson Reuters).

This post was originally authored by Patricia Carmona Botana.

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