Korean J Clin Pharm.  2024 Mar;34(1):39-61. 10.24304/kjcp.2024.34.1.39.

Comparison of the Expedited Programs for Innovative Drug Development and Approval among United States, European Union, and Republic of Korea

• Park J
• Shin H
• Lee JI

• KMID: 2564360
• DOI: http://doi.org/10.24304/kjcp.2024.34.1.39

Abstract

Background
The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs.
Methods
The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa- tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance.
Results
FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions.
Conclusion
Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

Keyword

Accelerated approval; breakthrough therapy; fast track; marketing authorization under exceptional circumstances; priority review