The Experience and Enlightenment of Cell Therapy Regulation Dual-track System in Japan

doi:10.13523/j.cb.1906020

China Biotechnology

2020, Vol. 40

Issue (1-2): 174-179 DOI: 10.13523/j.cb.1906020

Orginal Article

The Experience and Enlightenment of Cell Therapy Regulation Dual-track System in Japan

LI Yu,ZHANG Xiao(

)

School of Public Health, Southeast University, Nanjing 210009, China

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Abstract

With the development of life science and technology, innovative theories, techniques and clinical research of cell therapy are emerging. Cell therapy in China faces the favorable opportunity for development, and supervision has become an indispensable link to promote its industrialization. In recent years, the National Health Commission of the People’s Republic of China and China Food and Drug Administration have issued a series of policies and regulations to regulate the clinical research and clinical application of cell therapy. However, there are still no clear and detailed explanations on the issues of drug or technical supervision, supervisor and evaluation criteria. The basic content of cell therapy regulation dual-track system in Japan was clarified, its characteristics, and proposes policy recommendations for Chinese cell therapy supervision weresummarized.

Key words： Cell therapy regulation Stem-cell therapy Regenerative medicine

Received: 14 June 2019 Published: 27 March 2020

ZTFLH:

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Corresponding Authors: Xiao ZHANG E-mail: zhangxiao@seu.edu.cn

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Cite this article:

LI Yu,ZHANG Xiao. The Experience and Enlightenment of Cell Therapy Regulation Dual-track System in Japan. China Biotechnology, 2020, 40(1-2): 174-179.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.1906020 OR https://manu60.magtech.com.cn/biotech/Y2020/V40/I1-2/174

Table 1 Comparison of cell therapy regulation between Japan, the U.S. and the European Union

Fig.1 Flow chart of dual-track regulation in Japan

Fig.2 Risk classification criteria

Table 2 Comparison between clinical trial and clinical research

Fig.3 Comparison of cell therapy technology and products in Japan


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