15th – 16th October 2019

Kerry Hotel Pudong, Shanghai

China's regulatory summary

China's regulatory summary

Can Hospitals in China Manufacture Cell Therapies?

Cell and gene therapy regulations in China are changing fast. Keeping up to date is vital and we  recently spoke with Dr. Frances Verter, who has co-authored a paper titled ‘Regulations on Cell Therapy Products in China: a brief history and current status’*. She summarised some of the key learnings for us on how hospitals or civil institutions play a role and we’re happy to share them. Dr Verter’s whole paper will be published in Future Medicine later in August.

China has reviewed and rectified all regulations on the development of cell therapy products (CTPs) in civil institutions, releasing new guidelines in 2015 that became effective at the end of 2017.

1.    Under the current national regulations, China treats CTPs as biologic drugs, consistent with regulatory practices in Western nations.
2.    All approvals of CTPs under the old Chinese regulations have been erased, and no CTPs have been approved under the new regulations yet.
3.    During 2018, the Chinese government agencies that regulate medical research and development were also reorganized.
4.    The Chinese guidelines for development of CTPs are formed by a national expert committee, but enforcement is at the hospital level.
5.    At the end of 2018, China had 114 hospitals with approval to develop CTPs, including 102 civil hospitals plus 12 military and police hospitals.
6.    China now has two registries for human clinical trials: an internal registry for research trials and the existing ChiCTR registry for pharmaceutical trials.
7.    China has a new data base for products that have submitted IND applications to seek market approval.
8.    Policies in China continue to evolve and there is already a draft policy to expand the number of hospitals that can develop and administer CTPs.

Phacilitate Leaders Asia 2019

Registration for Phacilitate Leaders Asia and World Stem Cell Summit China, our inaugural advanced therapy conference in China is now live.

*Authors: Yijia Li(1), Frances Verter (2), Bin Wang(3), Ning Gu (4)

1       Public Translational Platform for Cell Therapy, Yangtze Delta Region Institute of Tsinghua University, Zhejiang, Hangzhou 311200, China

2       Parent’s Guide to Cord Blood Foundation, 23110 Georgia Ave., Brookeville MD 20833, United States

3       Center for Clinic Stem Cell Research, Affiliated Drum Tower Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210008, China