Earticle

초록

영어

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

목차

ABSTRACT
 연구 방법
 연구 결과
  미국 FDA
  유럽 EMA
  일본 MHLW 및 PMDA
  중국 CFDA
  ICH
 고찰 및 결론
 감사의 말씀
 참고문헌

키워드

저자

• 송윤경 [ Yun-Kyoung Song | 서울대학교 약학대학, 종합약학연구소, 대구가톨릭대학교 약학대학 ]
• 손민지 [ Minji Sohn | 서울대학교 약학대학, 종합약학연구소 ]
• 전아영 [ Ah Young Jeon | 서울대학교 약학대학, 종합약학연구소, 서울대학교병원, 약제부 ]
• 김재현 [ Jae Hyun Kim | 서울대학교 약학대학, 종합약학연구소 ]
• 지은희 [ Eunhee Ji | 가천대학교 약학대학 ]
• 오정미 [ Jung Mi Oh | 서울대학교 약학대학, 종합약학연구소 ]
• 김인화 [ In-Wha Kim | 서울대학교 약학대학, 종합약학연구소 ] Corresponding author

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615