What is the role of HAS in early access programs in France?
HAS assesses and grants early access authorizations for innovative [...]
Can patients apply directly for expanded access?
No, patients cannot apply directly. A licensed physician must apply [...]
Who grants compassionate use authorizations in France?
The ANSM (French National Agency for Medicines and Health Products [...]
What is the Early Access Authorization (AAP) in France?
AAP is a French program allowing access to innovative medicines [...]
Is there an FDA in France?
France does not have an FDA. The equivalent authority of [...]
What is the regulatory body of pharma in France?
The main regulatory authority for pharmaceuticals in France is the [...]
What is the role of an exploitant in France?
Role of an "Exploitant" in France: In the French pharmaceutical system, [...]
What is the difference between AP1 and AP2 in France?
Differences between AP1 and AP2 in France: AP1: Early Access [...]
What is the difference between the ATU and AAP programs in France?
The ATU (Temporary Authorization for Use) was the former French [...]
What is the Early Access Program (AAP) in France?
The Early Access Authorization (AAP) is a regulatory framework that [...]
