{"entity":{"id":"ansm","kind":"institution","name":"Agence nationale de sécurité du médicament et des produits de santé (ANSM)","aka":["ANSM","French National Agency for Medicines and Health Products Safety"],"tldr":"France's medicines regulator: it grants compassionate access to unapproved medicines for named patients, authorises clinical trials, and watches the safety of every medicine on the French market.","summary":"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.\n\nFor 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.","asOf":"2026-11-03","links":[{"label":"ANSM (French)","url":"https://ansm.sante.fr"},{"label":"Who we are (French)","url":"https://ansm.sante.fr/qui-sommes-nous/"},{"label":"Early and exceptional access (French)","url":"https://ansm.sante.fr/qui-sommes-nous/nos-missions/faciliter-lacces-a-linnovation-therapeutique/p/encadrer-lacces-precoce-aux-produits-de-sante"},{"label":"Medicines under exceptional access","url":"https://ansm.sante.fr/documents/reference/medicaments-en-acces-derogatoires"}],"tags":[],"related":["sante-publique-france","hospices-civils-de-lyon"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["has-france","ema","inca"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Saint-Denis","country":"FR","lat":48.921,"lng":2.346,"institutionType":"government","website":"https://ansm.sante.fr","programs":["Compassionate access authorisations (AAC)","Compassionate prescribing frameworks (CPC)","Opinion on pre-authorisation early access","Clinical trial authorisation","Pharmacovigilance","Innovation and orientation desk (GIO)"]},"route":"/institutions/ansm/","neighbours":{"institution":[{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"has-france","kind":"institution","name":"Haute Autorité de Santé","route":"/institutions/has-france/"},{"id":"hospices-civils-de-lyon","kind":"institution","name":"Hospices Civils de Lyon (HCL)","route":"/institutions/hospices-civils-de-lyon/"},{"id":"inca","kind":"institution","name":"Institut National du Cancer","route":"/institutions/inca/"},{"id":"sante-publique-france","kind":"institution","name":"Santé publique France","route":"/institutions/sante-publique-france/"}]}}