The Temporary Authorization for Use (Autorisation Temporaire d’Utilisation – ATU) was a former French regulatory framework that allowed access to innovative medicines before marketing authorization (MAA) for patients with serious diseases lacking therapeutic alternatives.
It was replaced in July 2021 by the new Compassionate Use Authorization (AAC) & Early Access Authorization (AAP) systems, which consolidated and modernized early access pathways.
Key takeaways
- Purpose:
Allowed early patient access to promising treatments before official marketing authorization, while ensuring safety and monitoring. - Types of ATU:
- Nominative ATU: For a named patient at the request of a physician.
- Cohort ATU: For groups of patients, requested by the manufacturer.
- Regulator:
- Managed exclusively by ANSM (French National Agency for Medicines and Health Products Safety).
- Conditions:
- Serious or rare disease.
- No satisfactory treatment alternative.
- Medicine had to show a positive benefit-risk profile based on clinical data.
- Duration & Obligations:
- Temporary, renewable authorization.
- Required follow-up data collection and monitoring.
- Transition to AAP (2021):
- ATUs were abolished and integrated into the AAC (Compassionate Use Authorization) & AAP (Early Access Authorization) systems.
- The new framework unified nominative and cohort procedures, strengthened data collection (PUT-RD), and clarified pricing/reimbursement rules.
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