医疗机构基于“三结合”中药新药研发及管理体系的构建  

The System Construction of Research and Development and Management of TCM New Drug in Medical Institutions Based on the“Three Combination”Review Evidence

作　　者：路遥[1] 申琳 鲁雨荍 刘殿娜 王乐[1] 陈旭[3] Lu Yao;Shen Lin;Lu Yuqiao;Liu Dianna;Wang Le;Chen Xu(Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Beijing Municipal Medical Products Administration,Beijing 100053,China;Tsinghua University,Beijing 100084,China)

机构地区：[1]北京中医药大学东方医院,北京100078 [2]北京市药品监督管理局,北京100053 [3]清华大学,北京100084

出　　处：《中国药事》2024年第2期147-151,共5页Chinese Pharmaceutical Affairs

基　　金：2021年度国家药品监督管理局委托研究课题(基于临床经验方-医疗机构制剂-中药新药研发模式的策略研究)。

摘　　要：目的:在中药审评审批制度改革的政策背景下,围绕医疗机构,探索中医药理论、人用经验和临床试验相结合(简称“三结合”)的审评证据体系落地举措,为医疗机构中药制剂及中药新药研发提供参考。方法:根据“三结合”审评证据体系下中药新药研发的相关要求,从机构层面加强人用经验研究相关配套建设,从管理层面搭建中药研发、成果转化服务平台,从临床层面规范开展人用经验研究,构建医疗机构中药新药研发及管理体系。结果:医疗机构中药新药研发及管理体系的构建,有助于将临床诊疗数据转变为支持中药新药注册的人用经验证据,通过提高中药研发水平促进中药新药转化。结论:在医疗机构构建基于“三结合”的中药新药研发及管理体系,是“三结合”审评证据体系落地、政策引导研发实践的路径之一。Objective:Under the policy background of the reform of the traditional Chinese medicine(TCM)review and approval system,the implementation measures of the review evidence system combining TCM theory,human use experience and clinical trials(referred to as the"three combinations")are explored centering on medical institutions,to provide references for the research and development(R&D)of TCM preparations and new drugs in medical institutions.Methods:According to the relevant requirements of the R&D of TCM new drugs under the"three combinations"review evidence system,the construction of supporting facilities related to human use experience research at the level of medical institutions was strengthened,the service platform of R&D of TCM and achievement transformation was built at the management level,and human use experience research at the clinical level was standardized,to build a R&D and management system for TCM new drugs in medical institutions.Results:The construction of R&D of TCM new drugs and management system in medical institutions is helpful to transform clinical diagnosis and treatment data into empirical evidence supporting the registration of TCM new drug,and promote the transformation of TCM new drug by improving the level of R&D of TCM new drug.Conclusion:The establishment of R&D of TCM new drugs and management system based on"three combinations"in medical institutions is one of the ways to land the evidence system of"three combinations"review and guide the research and development practice.

关 键 词：“三结合”审评证据体系 人用经验 医疗机构 中药新药研发 中药新药转化 医疗机构中药制剂 

分 类 号：R95[医药卫生—药学]