French agency assessing, authorising and monitoring medicines and devices

The French National Agency for the Safety of Medicines and Health Products (ANSM) is the competent authority responsible for regulating medicines, vaccines, and medical devices in France.

It oversees evaluation, market authorisation, and post-market surveillance. Its mission is to ensure quality, efficacy, and safety of health products while enabling access to therapeutic innovations.

ANSM plays a central role in compassionate and early access decisions, as well as in pharmacovigilance and risk monitoring activities.