The competent authority for research gene therapy medical products is the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS). The AFSSAPS carries out three core missions: scientific and medico-economic evaluation; laboratory control and advertising control; inspection of industrial sites. The Agency also coordinates vigilance activities relating to all products for which it is relevant. It also takes policing decisions in the name of the State with respect to two principles: contradiction and transparency. Decisions are discussed and motivated through the evaluation by a network of internal and external experts. The AFSSAPS operates as the unique portal for applications. In order to conduct a clinical gene therapy trial in France several bodies have to be consulted. Final authorization is granted by the head of the AFSSAPS. A specific streamlined procedure has been set up.

Gene therapy trial sponsors have to submit a single report to the AFSSAPS according to a specific application format including all information required by the review bodies. These include two commissions in charge with regulation of GMOs, the Commission de Génie Génétique (CGG; for determining the risk level of the organism and appropriate containment level) and the Commission de génie biomoléculaire (CGB; for evaluating the risk for release and determining an appropriate containment period and tests to be performed). The evaluation of the risk/benefit ratio of the proposed trial, the review of manufacturing processes, quality of the end product including viral validation and inspections are under the control of the AFSSAPS. Finally, the initiation of a clinical trial requires approval by a local bioethics committees, called Comité Consultatif de Protection des Personnes se Prêtant à une Recherche biomédicale (CCPPRB).

When taking a final decision, AFSSAPS takes into account its own evaluation, the advices of the CGG and CGB and the opinion of the CCPPRB. An approval can only be provided with the agreement of the Minister of the Environment and the Minister of Research. A single approval is provided, covering all aspects.

See also: Gene therapy in Germany and in Europe: regulatory issues. Qual. Assur. J. 1997; 2: 141-152. giving an outline on the regulatory issues of gene therapy in France.

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