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[Session 6] Drug Development in China; Recent Regulatory Changes and the Impacts
Session Chair(s)
Ling Su, PhD
Research Fellow
Shenyang Pharmaceutical University, 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)
The Evolving Multi-National Company’s China Development Strategy
Janet Lu, MS, RPh
Roche , China
Head of Regulatory Asia Pacific
Challenges & Opportunities of Innovative Drugs’ Development in China -A Biotech Company’s Perspective
Xiaojun (Wendy) Yan, MD, MBA
BeiGene (Beijing) Co., Ltd., China
Senior Vice President, Chief Regulatory Officer
Development Strategy Adaptions of Pharmaceutical Companies to China Regulatory Reform –Japanese Industry’s Perspective-
Tetsuomi Takano, RPh
Drug R&D Expert, Japan
Editor-in-Chief
Jianwu Zhang, PhD
CFDA, China
Principal Staff, Department of Drug and Cosmetics Registration
Qingzhu Huang
CDE, CFDA, China
Staff, Assistant Engineer, Office of Review Management
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