文献类型：期刊文献

英文题名：Realistic Dilemma and Solution of Stem Cell Application Supervision in China

作者：Xie, Xuekai[1];Chen, Jiajv[2];Chen, Yichao[3];Tao, Shuren[4]

机构：[1]East China Univ Sci & Technol, Sch Law, Shanghai, Peoples R China;[2]Zhejiang Univ Finance & Econ, Sch Law, Hangzhou, Zhejiang, Peoples R China;[3]Jinan Univ, Law Sch & Intellectual Property Sch, Guangzhou, Guangdong, Peoples R China;[4]Univ Sci & Technol China, Intellectual Property Res Inst, 96 Jinzhai Rd, Hefei 230026, Anhui, Peoples R China

年份：2022

卷号：31

期号：1-2

起止页码：1

外文期刊名：STEM CELLS AND DEVELOPMENT

收录：;WOS:【SCI-EXPANDED(收录号:WOS:000731449300001)】；

语种：英文

外文关键词：stem cell; regulatory system; two-track system; stem cell medical therapy; stem cell medicine

摘要：The regulatory system for the use of stem cells in China has experienced three stages of development. The internal reason for the constant changes is a lack of understanding of the legal nature of stem cells as a special object, and the external reason is the failure to reach a balance between encouraging and restricting the use of stem cells. With the introduction of China's first special regulations on stem cells in 2015, a dual-track application system for stem cell drugs and therapies has begun to take shape, but there still exists several problems such as gaps in the provisions of the upper law and unclear division of supervisory responsibilities. With respect to the regulatory system, a dual-track system with drug regulation as the mainstay and medical therapy as the supplement should be clarified. In terms of supervision design, stem cell medical therapy should be managed hierarchically according to the degree of risk, and a model should be formed in which the Ministry of Science and Technology conducts general supervision of the entire process, and the Health Commission and the Drug Administration conduct special supervision of clinical applications.