Agence nationale de sécurité du médicament et des produits de santé (ANSM)

The ANSM describes itself as the public body that, in the name of the State, gives access to health products in France and keeps them safe throughout their life. Its own page gives about 1,000 staff on three sites, Saint-Denis, Lyon and Montpellier-Vendargues.

For people with cancer its most visible role is the exceptional-access system created in 2021. The ANSM issues compassionate access authorisations (autorisations d'accès compassionnel, AAC) at a doctor's request for a named patient, for one year and renewable, for medicines that are not being developed for that use; and it sets compassionate prescribing frameworks (cadres de prescription compassionnelle, CPC), for three years and renewable, where an approved medicine is used outside its label. When a company asks the HAS for early access before a marketing authorisation, the ANSM must first give a binding opinion on the presumed benefit and risk. It also authorises clinical trials, keeps the public trial and medicines directories, and sits on the European Medicines Agency's scientific advice working party.