An ATU (temporary authorisation for use) is the French version of compassionate use and is granted by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France subject to the following conditions:
– Specials are to be used for treating, preventing or diagnosing serious or rare diseases
– No other appropriate treatment is available
– There is sufficient scientific evidence to show their efficacy and safety
In practice, there are two kinds of ATU: cohort ATUs and named patient ATUs.
In France, the ANSM grants an RTU (temporary recommendation for use) to cover off-label prescriptions that do not comply with the marketing approval obtained, as long as:
– There is a therapeutic need
– The risk/benefit ratio is considered as favourable, in particlular in reference to published scientific data concerning efficacy and tolerance
The aim is to ensure that medicinal products are used safely through patient follow-up organised by the laboratories concerned.
We have created a team specialised in handling and following up ATUs and RTUs and ready to share its experience with you and provide advice on your projects.