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[Session 6] Drug Development in China; Recent Regulatory Changes and the Impacts
Session Chair(s)
Ling Su, PHD
Research Fellow, Yeehong Business School, China
Since August 2015, under the guidance of the State Council’s “Opinions on the Reform of Drug and Medical Device Review and Approval System,” the CFDA has revealed and implemented a series of measures to reform the regulatory system in China. Its major objectives are to improve the review and approval processes for drugs and medical devices, to encourage innovation, to ensure clinical trial data quality, and to enhance quality of generic drugs. In addition to many regulatory changes, the Drug Administration Law is also under revision. This reform will prove to have broad impact on the pharmaceutical R&D and business in China for both local and multinational companies. In this session, three regulatory experts from different types of enterprises in China and Japan will share their experience and perspectives on the ongoing reform and exchange their opinions with CFDA/C-CDE speakers in panel discussion.
Speaker(s)
Janet Lv, MS, RPH
Senior Consultant, Roche Pharma Product Development China, Roche , China
The Evolving Multi-National Company’s China Development Strategy
Xiaojun (Wendy) Yan, MD, MBA
Strategic Advisor, DIA BOD, China
Challenges & Opportunities of Innovative Drugs’ Development in China -A Biotech Company’s Perspective
Tetsuomi Takano, RPH
Editor-in-Chief, Drug R&D Expert, Japan
Development Strategy Adaptions of Pharmaceutical Companies to China Regulatory Reform –Japanese Industry’s Perspective-
Jianwu Zhang, PHD
Division Director, Drug Registration Department, National Medical Products Administration, China
Qingzhu Huang
Staff, Assistant Engineer, Office of Review Management, CDE, CFDA, China