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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe


[S08] Deep Dive into China Regulatory Reform from Various Perspective

Session Chair(s)

Ling  Su, PhD

Ling Su, PhD

  • Professor
  • Shenyang Pharmaceutical University, 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)

Xiaofang  Cheng

Introduction to the Revision of the Drug Administration Law

Xiaofang Cheng

  • Principal Staff, Department of Policies and Regulations
  • National Medical Products Administration (NMPA), China
Gao  Jianchao

Overview Requirements for Advanced Therapies Review

Gao Jianchao

  • Center for Drug Evaluation, NMPA , China
Fei  Xu

Introduction to Overseas Inspection of Chinese Drugs

Fei Xu

  • Engineer, Center for Food and Drug Inspection of NMPA
  • National Medical Products Administration (NMPA), China