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Table. 3.

Table. 3.

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

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

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