France To Speed Up Patient Access To Unapproved Drugs

France's regulatory agency, ANSM, plans to introduce a faster and more equitable system for access to unapproved medicines for individual patients by streamlining its “temporary use authorization” system.

Accessible — France plans to ease access to unapproved drugs for individual patients. • Source: Shutterstock

The French regulatory agency ANSM is streamlining its “temporary use authorization” (ATU) system to speed up individual patients’ access to new drugs that are not yet approved in France and where the patient cannot obtain the medicine through a clinical trial.

The ATU system gives patients access to unapproved new medicines where there is a pressing need, there are no therapeutic...