What is the difference between AP1 and AP2 in France?

Q: What is the difference between AP1 and AP2 in France?

Differences between AP1 and AP2 in France: AP1 : Early Access before marketing authorization ( MAA ) → allows use of an innovative medicine still under regulatory review. AP2 : Early Access after marketing authorization (MAA) but are still awaiting reimbursement approval and/or completion of final price negotiations → ensures patient access during the pricing/HTA process. Both require: serious/rare/disabling disease, no alternative, urgent need, strong presumption of efficacy/safety, and real-world data collection ( PUT-RD ) .

Differences between AP1 and AP2 in France:

AP1: Early Access before marketing authorization (MAA) → allows use of an innovative medicine still under regulatory review.
AP2: Early Access after marketing authorization (MAA) but are still awaiting reimbursement approval and/or completion of final price negotiations → ensures patient access during the pricing/HTA process.

Both require: serious/rare/disabling disease, no alternative, urgent need, strong presumption of efficacy/safety, and real-world data collection (PUT-RD).