首页|我国干细胞制剂的监管现状与进展

我国干细胞制剂的监管现状与进展

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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.
Regulatory Status and Progress of Stem Cell Preparations in China
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.

stem cellstem cell therapyclinical researchregulation

曹涵博、张强、王莉芳、蔡虎、冯润东

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陕西省食品药品监督检验研究院,陕西 西安 710065

陕西省药品疫苗检查中心,陕西 西安 710065

干细胞 干细胞疗法 临床研究 监管

陕西省药品科学监管和监管科学研究项目

SXYJ202202

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(3)
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