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医疗机构中药人用经验收集现状分析及对策建议

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为建立符合中药特点的技术评价体系,推进中药传承与创新发展,我国正在构建中医药理论、人用经验和临床试验相结合的中药注册审评证据体系。人用经验支持中药新药注册审评具有重要意义。本文通过调研上海市20家医疗机构分析中药人用经验收集现状和共性问题发现,医疗机构已有意识开展人用经验收集用于中药制剂或新药开发,但目前收集人用经验的硬件条件、人员能力和医疗机构对此项工作的重视程度仍不容乐观,收集过程存在困难,90%的机构认为收集数据的质量无法达到药品注册要求。医疗机构与监管机构应共同努力,通过完善收集方法、统筹提升研究能力、加强信息化系统建设、参照GCP原则加强研究质量管理等,完善并规范中药人用经验收集,以获取高质量证据材料用于支持中药创新转化。
Current situation analysis and countermeasures of human experience collection of traditional Chinese medicine in medical institutions
In order to establish a technical evaluation system in line with the characteristics of traditional Chinese medicine(TCM)and promote the inheritance and innovative development of TCM,China is building a TCM registration and evaluation evidence system combining TCM theory,human experience,and clinical trials.Human experience is of great significance to support the registration and evaluation of new drugs of TCM.Based on the survey of 20 medical institutions in Shanghai,this paper analyzed the current situation and common problems of human experience collection of TCM.It was found that medical institutions had been aware of carrying out human experience collection for the development of TCM preparations or new drugs.However,the hardware conditions,personnel capabilities,and the importance of medical institutions in collecting human experience were still not optimistic.There were difficulties in the collection process.90%of institutions believed that the quality of collected data did not meet the requirements of drug registration.Regulators and medical institutions should work together to improve and standardize the collection of human experience of TCM by improving collection methods,increasing research capabilities,strengthening the construction of information systems,and enhancing research quality management according to GCP principles,so as to ultimately obtain high-quality evidence materials to support the innovation and transformation of TCM.

medical institutiontraditional Chinese medicinehuman experienceresearch and analysis

牟娜、卓阳、高敏洁

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上海药品审评核查中心,上海 201203

医疗机构 中药 人用经验 调研分析

2024

中国新药与临床杂志
中国药学会 上海市食品药品监督管理局科技情报研究所

中国新药与临床杂志

CSTPCD北大核心
影响因子:0.967
ISSN:1007-7669
年,卷(期):2024.43(8)