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[Session 1] Update on Regulatory Environment in East Asia
Session Chair(s)
Jessica (Chih Min) Lin, MBA, MSC
General Manager of Development Division, Chugai Pharma Taiwan Ltd., Taiwan
Junko Sato, PHD
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
US FDA Commissioner Dr. Robert M. Califf has said: “A successful FDA is a critical factor for better public health in this changing world. ...we need to give consumers and patients even more confidence that their food is safe and their medical products are safe and effective.” Since our Eastern Asia population is equivalent to 21.62% of the total world population (and five times America’s), East Asia Regulatory Authorities have an even higher mission to provide people with more confidence in their environment and in safe, efficacious and convenient treatments to alleviate their suffering from disease. In this session, regulatory authorities from PMDA, CFDA, MFDS and TFDA will provide highly-anticipated updates from their respective regulatory environments, and inform industry how to work closely with regulatory authorities to accelerate the review and approval process and approval for new, innovative medicines which can bring great benefit and hope to patients and their families.
Speaker(s)
Noriatsu Kono, MPHARM
Organizational management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Recent topics in PMDA (Support for the practical application of innovation Advancements)
Jianwu Zhang, PHD
Division Director, Drug Registration Department, National Medical Products Administration, China
The Latest Progress on the Reform of Pharmaceutical Review and Approval System in China
Gyu-Han Chae, MSC
Deputy Director / Planning Expert, Pharmaceutical Policy Division, Ministry of Food and Drug Safety (MFDS), Korea, Republic of
Update on Regulatory Environment in Korea
Yi-Chu Lin, PHD
Senior Specialist of the Division of Medicinal Products, TFDA Chinese Taipei, Taiwan
Update on Regulatory Environment in TFDA