[Summary Compassionate prescription in dermatology]

The availability of medicines in France is based on obtaining a Marketing Authorization (MA) issued by the European Medicines Agency (EMA). However, this procedure does not cover all medical needs, such as certain rare diseases or specific clinical forms of certain diseases not covered by the MA wording. In order to better secure these off-label prescriptions, in 2021, the french legislature created two procedures: compassionate access authorization (CAA) issued for a specific patient at the request of a clearly identified practitioner responsible for monitoring the patient; and the compassionate prescribing framework (CPF) which provides a regulatory framework for drugs without marketing authorization in a specific indication for rare, serious, or debilitating diseases after analysis of a scientific file suggesting a favorable risk-benefit ratio. The prescriptions made within these frameworks are monitored according to a temporary use protocol and a data collection system that allows the tolerance of these treatments and, potentially, their effectiveness to be assessed. Examples of drugs that have obtained AACs or CPCs in the field of dermatology are presented.