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[Session 4] Drug Development in China; Recent Regulatory Changes and the Impacts
Session Chair(s)
Ling Su, PHD
Research Fellow
Yeehong Business School, China
The regulatory reform in China that started in mid-2015 has entered the third year and is progressing well. In 2017, the China Food and Drug Administration (CFDA) became a regulatory member of ICH. These changes have brought about major changes in the pharmaceutical R&D and regulatory processes in China. The clinical trial review and approval process, the increasing trend of in- and out-license collaborations and simultaneous development, and the Marketing Authorization Holder program are among the most notable areas enhanced by the reform. In these session, speakers from the CFDA and the industry will share with the audience the update of the reform progress and their experience and perspectives on how the reform has changed the drug development in China.
Speaker(s)
Update on Regulatory Reform
Dan Zhang, MD, MPH
Fountain Medical Development Ltd. (FMD), China
Experience of MAH Pilot in China
Li Ning, MD, PHD
Shanghai Junshi TopAlliance Biosciences, China
CEO
Experience of In-Licensing Product and Leveraging on Overseas Early Clinical Data for China Development
Min Dong
EOC Pharma, China
SVP, Clinical Development
Accelerating the Development of Life-Changing Medicines for Chinese Patients through Innovation and Partnership
George Chen, MD, MBA
AstraZeneca China, China
Senior VP, Global Medicines Development, Head of China Development Unit