한국임상약학회지 (Korean Journal of Clinical Pharmacy)

  • 제34권1호
  • /
  • Pages.39-61
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  • 2024
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  • 1226-6051(pISSN)
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  • 2508-786X(eISSN)
한국임상약학회 (Korean College Of Clinical Pharmacy)
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한국, 미국, 유럽의 혁신적 의약품 개발 및 허가제도 비교 연구

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

  • 박지연 (서울대학교 약학대학 종합약학연구소) ;
  • 신혜원 (서울대학교 약학대학 종합약학연구소) ;
  • 이장익 (서울대학교 약학대학 종합약학연구소)
  • Jiyeon Park (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Hyewon Shin (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Jangik. I. Lee (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
  • 투고 : 2024.01.27
  • 심사 : 2024.03.15
  • 발행 : 2024.03.31
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초록

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 information 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 innovative medication development.

키워드

과제정보

논문을 작성하고 검토하는데 도움을 주신 서울대학교 약학대학의 임하연 연구원님, 정열매 연구원님, 강민서 연구원님, 유승현 연구원님께 감사드립니다.

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