What is an ATU ?
In France, the use of pharmaceutical specialties is subject to conditions guaranteeing their therapeutic value, their quality and their safety.
In most cases, a marketing authorization (MA) issued by the National Health Authorities is required to market the pharmaceutical specialty. Obtaining this MA is long and while waiting for this authorisation, patients may not benefit from treatment.
The authorities can grant earlier access to a drug: the temporary authorization for use (ATU) under certain circumstances :
- When it is needed to treat, prevent or diagnose serious or rare disease.
- When there is no suitable treatment available on the market.
- If the efficacy of the medicinal product and its safety in use are presumed and if the treatment cannot be postponed.
There are two types of ATU
The "ATU cohort" is precribed for a group of patients, and the "nominative ATU" prescribed individually for each patient.
The nominative ATU is prescribed under the responsibility of the physician when the drug is likely to be of benefit to the patient, and each prescription is subject to validation by ANSM (French National Health Authorities).