Autorisation d’accès précoce (Early access authorisation)

The AAP is an authorization granted by the French authorities allowing a company to market a medicinal product before its full authorization, under certain conditions.

The purpose of the AAP is to offer patients in France suffering from serious or life-threatening diseases early access to innovative medicinal products that have shown promising therapeutic results in initial clinical trials while ensuring the safety of these patients.

The AAP procedure is an accelerated procedure, which allows a medicinal product to be made available to patients before the completion of all clinical trials and the submission of a marketing authorization application (MAA).

The AAP procedure is open to all companies, whether they are based in France or not.

The AAP procedure is managed by the French Medicines Agency (ANSM).