Overview of regulatory procedures in France

Overview of regulatory procedures in France

Act No. 2012-300 of March 5, 2012 (the Jardé Law) on research involving human subjects has amended the classification and regulatory procedures of research on humans. This Act will come into force once the implementing decrees are published in the French Official Journal. The information on this page will be updated when this happens.

The National Agency for the Safety of Medicines and Health Products (ANSM), created by the Act of December 29, 2011 on improving the safety of medicines and health products, replaced AFSSAPS on May 1, 2012, following the publication of Decree No. 2012-597 of April 27, 2012.
Cases previously dealt with by the AFSSAPS are now handled by the ANSM.

For biomedical research with or without health products

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For clinical research using biological samples of human origin
(excluding embryos, embryonic stem cells, material from terminated pregnancies and the procurement of organs and tissues from deceased donors)

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For clinical research using personal health data
Incomplete or reversible anonymity means that the person remains identifiable by:
- their full identity. This is referred to as directly identifiable data;
- a code which replaces the person’s full identity. This is referred to as indirectly identifiable data;
- cross-checking information (such as where the medical care is taking place, the disease, gender, date of birth, etc.). This is also referred to as indirectly identifiable data.
In all of the above cases, in the absence of compliance with a baseline methodology (e.g. the CNIL’s MR-001), or if there is no applicable baseline methodology, the following procedures should be adopted:

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