摘要
目的为我国干细胞产业发展的监管提供参考。方法总结国内外干细胞临床研究与应用现状、干细胞治疗立法与监管现状,分析干细胞产业的发展现状及我国干细胞产业发展面临的问题,并有针对性地提出建议。结果与美国等发达国家相比,我国干细胞的临床研究及其应用存在伦理机制建设不全,立法欠缺,监管体系不完整等问题。结论建议我国加强对干细胞临床研究伦理机制的建设,针对干细胞产品或干细胞疗法进行立法,建立符合我国基本国情的干细胞产业监管体系,形成干细胞产业研发、成果转化及市场应用的良性循环,以规范、安全地推进我国干细胞产业的发展。
Objective To provide a reference for the regulatory of the development of China′s stem cell industry.Methods The current status of clinical research and application of stem cells,legislation and regulation of stem cell therapy at home and abroad,and the development status of the stem cell industry were summarized.The problems faced by the development of stem cell industry in China were analyzed to put forward targeted suggestions.Results Compared with the developed countries such as the United States of America(USA),China′s clinical research and application of stem cells had problems such as incomplete ethical mechanisms construction,lack of legislation,and incomplete regulatory system.Conclusion It is recommended that China strengthen the construction of ethical mechanisms for clinical research on stem cells,legislate for stem cell products or stem cell therapies,establish a regulatory system for the stem cell industry that is in line with China′s national conditions,and form a virtuous cycle of stem cell industry research and development,achievement transformation,and market application,in order to promote the development of stem cell industry in a standardized and safe manner in China.
作者
曹涵博
张强
王莉芳
蔡虎
冯润东
CAO Hanbo;ZHANG Qiang;WANG Lifang;CAI Hu;FENG Rundong(Shaanxi Institute for Food and Drug Control,Xi′an,Shaanxi,China 710065;Shaanxi Provincial Drug and Vaccine Inspection Center,Xi′an,Shaanxi,China 710065)
出处
《中国药业》
2024年第3期26-30,共5页
China Pharmaceuticals
基金
陕西省药品科学监管和监管科学研究项目[SXYJ202202]。
关键词
干细胞
干细胞疗法
临床研究
监管
stem cell
stem cell therapy
clinical research
regulation
作者简介
第一作者:曹涵博,女,博士,主管药师,研究方向为食品、药品、化妆品质量控制,(电子信箱)Hannecao@163.com;通信作者:冯润东,男,硕士,副主任药师,研究方向为食品、药品、化妆品质量控制,(电子信箱)fengdong83@163.com。
