The European Medicines Agency (EMA) does not publish an official acceptance rate for marketing authorization applications. However, historical data suggests that approximately 70-80% of applications receive a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
Success rates vary by application type, with orphan drugs and generics facing different approval benchmarks. Rigorous pre-submission processes, including scientific advice and protocol assistance, improve approval chances. The EMA emphasizes transparency, providing detailed assessment reports for all applications, regardless of outcome.
