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Regulations and Guidelines for Planning and Design of Multi-regional Clinical Trials
Korean J Clin Pharm 2018;28(2):146-153
Published online June 30, 2018
© 2018 Korean College of Clinical Pharmacy.

Yun-Kyoung Song1,2, Minji Sohn1, Ah Young Jeon1,3, Jae Hyun Kim1, Eunhee Ji4, Jung Mi Oh1, and In-Wha Kim1*

1College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul 08826, Republic of Korea
2College of Pharmacy, Daegu Catholic University, Gyeongbuk 38430, Republic of Korea
3Department of Pharmacy, Seoul National University Hospital, Seoul 03080, Republic of Korea
4College of Pharmacy, Gachon University, Incheon 21936, Republic of Korea
Correspondence to: * In-Wha Kim, College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 08826, Republic of Korea
Tel: +82-2-880-7736, Fax: +82-2-882-9560 E-mail:
Received December 6, 2017; Revised May 14, 2018; Accepted May 15, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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.
Keywords : Multi-regional clinical trials, global drug development, guideline, regulation

June 2018, 28 (2)
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