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[Session 2] Regulator’s Perspective for Drug Development Using Asia MRCT
Session Chair(s)
Yoshiko Komuro, PHD
Director, Office of Research Administration, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Minsoo Park
, KCGI, Korea, Republic of
NDAs based upon the results of MRCTs (multi-regional clinical trials) are steadily increasing. Drug development using Asian MRCTs is especially expected to be a pivotal strategy for global or Asian applications because of the high degree of similarity of ethnic factors within the region. Regulatory authorities have also released guidelines/notices to promote their respective country’s participation in MRCT and to use the clinical data from MRCT for regulatory applications. On the other hand, challenges in evaluating MRCT data remain. In this session, Asian regulators will share their review experiences of NDAs using such development strategies, and the current status surrounding MRCTs in Asia. Planning development strategies, review discussion matters, and future issues will also be discussed.
Speaker(s)
Siyuan Qian
Senior Reviewer, Associate Chief Pharmacist, Office of Clinical Evaluation II , CDE, CFDA, China
Regulator's Perspective for Drug Development using Asia MRCT (CDE, CFDE)
I-Chun Lai, MD, MS
Senior Director, Division of Consultation, Center for Drug Evaluation, Taiwan, Taiwan
Regulatory Perspectives of Asian MRCT (T-CDE)
Nam Soo Kim
Deputy Director, Biopharmaceutical Policy Division, Ministry of Food and Drug Safety (MFDS), Korea, Republic of
Regulatory Management of NDA and MRCT in Korea
Naoto Kato
Director, Office of New Drug III / International Senior Training Coordinator, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Experiences of Multi Regional Clinical Trials (MRCTs) (Asian Trials)