Regulations on cell therapy products in China: a brief history and current status

被引：7
|
作者：
Li, Yijia [1 ]
Verter, Frances [2 ]
Wang, Bin [3 ]
Gu, Ning [4 ]
机构：
[1] Tsinghua Univ, Yangtze Delta Reg Inst, Publ Translat Platform Cell Therapy, Hangzhou 311200, Zhejiang, Peoples R China
[2] Parents Guide Cord Blood Fdn, 23110 Georgia Ave, Brookeville, MD 20833 USA
[3] Nanjing Univ, Affiliated Drum Tower Hosp, Sch Med, Ctr Clin Stem Cell Res, Nanjing 210008, Jiangsu, Peoples R China
[4] Southeast Univ, Sch Biol Sci & Med Engn, Nanjing 211189, Jiangsu, Peoples R China
来源：
REGENERATIVE MEDICINE | 2019年 / 14卷 / 08期
关键词：
cell therapy; china; clinical trial; legal/regulatory; manufacturing; policy; regulation;
D O I：
10.2217/rme-2019-0069
中图分类号：
Q813 [细胞工程];
学科分类号：
摘要：
This report describes changes to cell therapy research and clinical practice in China as a result of guidelines from the central government finalized at the end of 2017. The tables list Chinese authorities and regulations on human cells for medical research over the years 1993-2018. Under the new regulations, cell therapy products (CTPs) are treated like drugs, in alignment with policy in the USA and European Union. At civil institutions in China, there are now two pathways for human clinical trials: research versus pharmaceutical development. At the end of 2018, trials of CTPs were only authorized at 114 approved hospitals. It is hoped that the new policies will help CTPs developed in China gain acceptance by health regulators in the west.
引用
收藏
页码：791 / 802
页数：12
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