Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years.

Fiche publication

Date publication

mai 2021

Journal

European journal of cancer (Oxford, England : 1990)

Auteurs

Membres identifiés du Cancéropôle Est :
Dr BOUDALI Lotfi

Tous les auteurs :
Jacquet E, Kerouani-Lafaye G, Grude F, Goncalves S, Lorence A, Turcry F, Brunel L, Belgodere L, Monard A, Guyader G, Boudali L, Albin N

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/33838392

Résumé

The cancer incidence continues to rise worldwide. Medical innovation has a major impact on patient survival, but within drug development, it can take more than 10 years to obtain marketing authorisation (MA). The time required for access to therapeutic innovation remains critical, so France has developed a specific expanded access program named ATU, which allows the administration of drugs before the European Medicines Agency (EMA) approval. The purpose of this study is to put in perspective the average time to access antineoplastic drugs worldwide, taking into account ATU, US Food and Drug Administration (FDA) and EMA approvals.