ATU | Temporary authorisation for use

Q: ATU | Temporary authorisation for use

Temporary authorisation for use of a non-approved medicine The Temporary Authorisation for Use (ATU) was a French framework granting access to medicines before marketing authorisation , in cases of severe diseases without therapeutic alternatives. It could be nominative or cohort-based, with close monitoring by ANSM . Since 2021, this scheme has been replaced by the Early Access ( AAP ) and Compassionate Access ( AAC ) frameworks. They now regulate early patient access to innovative therapies within a modernised regulatory system.

Temporary authorisation for use of a non-approved medicine

The Temporary Authorisation for Use (ATU) was a French framework granting access to medicines before marketing authorisation, in cases of severe diseases without therapeutic alternatives.

It could be nominative or cohort-based, with close monitoring by ANSM. Since 2021, this scheme has been replaced by the Early Access (AAP) and Compassionate Access (AAC) frameworks. They now regulate early patient access to innovative therapies within a modernised regulatory system.