Authorization for human embryo research
Published on 4 April 2025
Research on the human embryo is strictly regulated by law, and requires prior authorization issued by the Agence de la biomédecine, after consulting the Conseil d'orientation. On this page, you will find the procedure to follow, as well as the documents you need to submit your application to the Agency.
Initial request
Applications should preferably be sent electronically, by registered letter with acknowledgement of receipt, or delivered by hand with receipt, to the following address: juridique@biomedecine.fr Agence de la biomédecine - Direction juridique - 1 avenue du Stade de France 93212 Saint-Denis La Plaine Cedex - France
After checking the admissibility of the authorization application, the Agency acknowledges receipt. Where the required documents or information are missing, the Agency sets a deadline by which they must be supplied.
The General Management of the Agence de la biomédecine notifies the applicant establishment or organization of its decision within 4 months of submission of the application. Silence on the application during this period is deemed to constitute an implicit decision to refuse authorization.
The person in charge of the research sends an annual report to the Agency's General Management, together with the final research report as soon as it has been completed.
Obligations of authorized teams
Once authorized, teams must declare the actual start date of their project using the following form (to be sent to juridique@biomedecine.fr):
Request for modification of research protocol authorization
The Agency must be systematically informed by letter of any modification occurring during the implementation of an authorized embryo research protocol.
The Agency's legal department will then indicate whether the change constitutes a substantial modification. In this case, a new authorization application file must be submitted. It will then be examined according to the same procedure as the initial application (see above).
If this is not the case, only the technical information required by the Agence de la biomédecine to keep files up to date will need to be provided.
Renewal request
Authorizations for embryo research are issued for a maximum of 5 years. In accordance with legislative and regulatory provisions, the person responsible for the research must send the Agency a final report on completion of the research.
If you have not yet completed your research protocol, or if you wish to continue conserving embryos for research purposes, you must submit a new application for authorization to the Agency.
The application will be processed under the same conditions as the initial application (see above).
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