January 2023: France Regulatory Update

On January 19, 2023, a press release was posted on the Ministry of Health and Prevention website’s News/Press page.

On January 18, 2023, work on a minimum viable product (MVP) of a national clinical trial database related with the Information System for Research Involving the Human Person (RIPH 2G) was launched.

During the first half of 2023, the Directorate-General for Health (DGS) and the Digital Health (DNS) along with the Agency for Health Innovation (AIS), will begin work on implementing a national basic MVP for clinical trials. This initiative is a part of the health component of France 2030 “Health Innovation Plan 2030.”

The MVP will be called ECLAIRE (Accessible Interconnected Clinical Tests for Research Open to the Ecosystem).

Santé.fr will be the MVP’s first interface with the national base, with the potential highlighting of certain therapeutic areas according to the public health priorities identified by the Ministry of Health and Prevention.

Working groups in the construction of the MVP will be set up by the end of January, which will include patient associations, manufacturers, and researchers, around themes such as the user experience on Santé.fr, the legal aspects around clinical trial data and the GDPR, the validation circuits of simplified information translated into French as well as the possibility of completing them, and pedagogical elements for volunteers.

Additional information can be found here.