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Update from the CFDA
Session Chair(s)
Ling Su, PhD
Research Fellow
Shenyang Pharmaceutical University, Yeehong Business School, China
In August 2015, China’s State Council issued an document entitled "The Opinions on Reforming Review and Approval Process for Drugs and Medical Devices", unveiling a long-awaited major regulatory reform plan, with five main goals: to improve regulatory review and approval quality, address the drug application backlog, upgrade quality of generic drugs, promote innovative drug research and development, and to enhance regulatory transparency. Since then, many reform measures have been implemented. In this session, members from various organizations in the China Food and Drug Administration (CFDA) in will discuss the major initiatives and progress, as well as the future directions of the regulatory reform in China.
Learning Objective : Identify and understand the latest CFDA’s activities and initiatives in regulatory reform as well their impacts on Chinese pharmaceutical regulation and enforcement; Recognize China’s evolving regulatory environment and future development.
Speaker(s)
CDE Reform Measures
Zhimin Yang, MD
National Medical Products Administration (NMPA), China
Deputy Director, Center for Drug Evaluation
Strengthen Regulatory Enforcement on Clinical Trial Integrity and Data Quality
Rong Zhang, MS
China Food and Drug Administration (CFDA), China
Deputy Chief Technician, Center For Food and Drug Inspection
ADR Monitoring in China
Duo Dong
China Food and Drug Administration (CFDA), China
Deputy Division Director, National Center for ADA Monitoring
Panelist
Xiaoling Qin
China Food and Drug Adminsitration (CFDA), China
Deputy Director General, Department of International Cooperation
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