体细胞治疗(技术)临床研究和临床应用监管完善研究  

Research on improved regulation for clinical research and application of somatic cell therapy (technology)

作　　者：郑媛媛 霍增辉[1] ZHENG Yuanyuan;HUO Zenghui(School of Humanities,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学人文学院,北京102488

出　　处：《卫生软科学》2024年第7期41-45,共5页Soft Science of Health

摘　　要：查阅我国体细胞治疗在监管层面的相关规定及文献,分析我国体细胞治疗临床研究和临床应用监管现状。发现我国体细胞治疗临床研究和临床应用存在监管体系尚不健全、没有分级分类监管、监管职权存在交叉、对伦理委员会监管不足、处罚力度不足等问题。并提出完善监管体系、采取分级分类监管、明确监管职权、完善伦理委员会的监管制度、加大对医疗机构及医务人员的监管力度等建议。The relevant regulations and literatures referred to regulation of somatic cell therapy are reviewed to analyze the current regulation of clinical research and application of somatic cell therapy in China.It is found that there are some problems in clinical research and clinical application of somatic cell therapy in China,such as incomplete supervision system,no hierarchical and classified supervision,overlapping supervision powers,insufficient supervision for ethics committee and insufficient punishment.It also puts forward suggestions on improving the supervision system,adopting hierarchical and classified supervision,clarifying the supervision powers,improving the supervision system of ethics committee,and strengthening the supervision for medical institutions and medical personnel.

关 键 词：体细胞治疗 临床研究 临床应用 监管 

分 类 号：R329.2[医药卫生—人体解剖和组织胚胎学]