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Session 1: Update on Regulatory Environment in East Asia
Session Chair(s)
Yoshiko Komuro, PHD
Director, Office of Research Administration
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Minsoo Park
KCGI, Korea, Republic of
With the accelerated globalization of drug development in recent years, the importance of clinical development utilizing multi regional clinical trials (MRCT) especially in east Asian region is increasing mainly because of the higher similarity of ethnic factors within the region. Under such circumstances, Case of new drugs approved based on the results of MRCT in east Asian region are accumulating. In addition, since the postmarketing safety measures including the maintenance of labeling required by the regulatory agency varies in each region, Marketing Authorization Holders have to deal with each local regulations. In this session, experts from each regulatory agency will introduce the recent regulatory issues about drug development and safety measures in each region. Furthermore, topics regarding the new framework which some regulatory agencies have started to facilitate innovative drug development will be also introduced. It is expected to be helpful for drug development and fostering in east Asian region by understanding and utilizing the updated regulatory information.
Speaker(s)
Update on Regulatory Environment in MHLW/PMDA
Koshin Kiyohara, MPHARM, MSC
Ministry of Health, Labour and Welfare (MHLW), Japan
Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau
Update on Regulatory Environment in MFDS
Myung-jung Kim, MS
Ministry of Food and Drug Safety (MFDS), Korea, Republic of
Director, Clinical Trials Management Division, Pharmaceutical Safety Bureau
Update on Regulatory Environment in TFDA
Hsueh-Yung (Mary) Tai, MS
TFDA, Taiwan
Deputy Director, Division of Medicinal Products