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[S08] Deep Dive into China Regulatory Reform from Various Perspective
Session Chair(s)
Ling Su, PhD
Research Fellow
Shenyang Pharmaceutical University, Yeehong Business School, China
China regulatory reform has caused various changes in drug development in China. The drug development process has been shifted from conventional way to advanced way utilizing improved regulatory system for acceleration of innovative drug development. This session will cover recent regulatory environment for innovative drug and advanced therapy (gene therapy or cell therapy) by agency, and actual experience using new regulatory scheme by industry. Lastly, regulatory activities on intellectual proprietary protection which has been engaged by NMPA is also presented as a hot topic.
Speaker(s)
Introduction to the Revision of the Drug Administration Law
Xiaofang Cheng
National Medical Products Administration (NMPA), China
Principal Staff, Department of Policies and Regulations
Overview Requirements for Advanced Therapies Review
Jianchao Gao
Center for Drug Evaluation, NMPA , China
Senior ReviewerBiological Department
Introduction to Overseas Inspection of Chinese Drugs
Fei Xu
National Medical Products Administration (NMPA), China
Engineer, Center for Food and Drug Inspection of NMPA
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