pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Comparison of the expedited programs that provide the innovative drug development and approval among the United States, the European Union, and the Republic of Korea
| FDA | EMA | MFDS | |
|---|---|---|---|
| Intensive regulatory guidance | Fast Track | PRIority MEdicines (PRIME) | Accelerated Examination |
| Breakthrough Therapy | |||
| Conditional approval | Accelerated Approval | Marketing Authorisation under Exceptional Circumstances (MAEC) | Conditional Permission |
| Conditional Marketing Authorisation (CMA) | |||
| Shorter review clock | Priority Review | Accelerated Assessment | Accelerated Examination |
EMA, European Medicines Agency; FDA, Food and Drug Administration; MAA, marketing authorisation application; MFDS, Ministry of Food and Drug Safety