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Table. 2.

Table. 2.

Expedite programs for the innovative drug development and approval in the United States, the European Union, and the Republic of Korea

Designations Approvals
United States ((FDA) Fast Track Accelerated Approval
Breakthrough Therapy
Priority Review

European Union (EMA) PRIority MEdicines (PRIME) Marketing Authorisation under Exceptional
Accelerated Assessment Circumstances (MAEC)
Conditional Marketing Authorisation (CMA)

Republic of Korea (MFDS) Accelerated Examination* Conditional Permission*
Expedited Review** Conditional Approval***

EMA, European Medicines Agency; FDA, Food and Drug Administration; MFDS, Ministry of Food and Drug Safety

*In accordance with the Pharmaceutical Affairs Act (Amendment 2024)

**In accordance with the Regulation on Pharmaceutical Approvals, Notifications and Reviews (Amendment 2023)

***In accordance with the Regulation on Safety of Pharmaceuticals, etc. (Amendment 2024)

Korean J Clin Pharm 2024;34:39-61 https://doi.org/10.24304/kjcp.2024.34.1.39
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