Gene Therapy Legislation in France
The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs can be regulated under the contained use and/or the deliberate release frameworks. A decision is taken case-by-case. Applicants should submit the dossier to the Ministry of Research (Ministère de l'Enseignement supérieur, de la Recherche et de l'Innovation) for the classification and the conditions of contained use of the GMO. The Ministry of Research gives an opinion on the type of contained use regarding manufacturing and administration and it also states whether this research presents a risk of deliberate release of GMO into the environment. When a risk of deliberate release is identified, the applicant should submit a second dossier to the Ministry of Environment (Ministère de la Transition écologique et solidaire) for the deliberate use assessment. The applications to seek authorization under the clinical trials framework and under the GMO framework are not linked; both applications can be submitted in parallel.
Additional information on the conduct of clinical trials can be found at:
- https://www.enseignementsup-recherche.gouv.fr/cid66768/o.g.m.-en-milieu-confine-procedure-ad ministrative.html
- https://www.hautconseildesbiotechnologies.fr/en/demarche/cas-particulier-dossiers-recherche-bi omedicale-veterinaire-produits-therapie-genique-ou-0
- https://ansm.sante.fr/Activites/Medicaments-et-produits-biologiques/Essais-cliniques-portant-sur-l es-medicaments-et-produits-biologiques/(offset)/0
- Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
- High Council for Biotechnology
- Minister of Research (MESR), covering the contained use aspect.
Application forms to seek authorisation for the GMO aspects
Application forms can be found at: https://duo.adc.education.fr/duo/connexion.jsp
Public consultation
There is a public consultation on GMO aspects prior to granting authorization for a period of between 15 to 30 days.
National authorities involved
Authorization of clinical trials:
Agence Nationale de Sécurité du Médicament et des produits de Santé (ANSM)
143/147 bld Anatole France 93285 Saint Denis CEDEX
e-mail:
https://ansm.sante.fr
Authorisation of GMO aspects:
Ministère de l’enseignement supérieur, de la recherche et de l’innovation (MESRI): Competent authority under the contained use framework.
e-mail:
https://www.enseignementsup-recherche.gouv.fr/
Ministère de la Transition écologique et solidaire (MTES): Competent authority under the deliberate release framework.
e-mail:
https://www.ecologique-solidaire.gouv.fr/
Haut Conseil des biotechnologies (HCB): The HCB is an independent body whose role is to inform public decision-making. It delivers opinions on all biotechnology-related issues.
246, boulevard Saint Germain, 75007 Paris
https://www.hautconseildesbiotechnologies.fr
(Last reviewed by the Competent Authority: December 2017)