中药人用经验研究质量管理指南  

Guidelines for quality control of human use experience study on traditional Chinese medicine

作　　者：唐雅琴[1,2] 杨忠奇 唐兆安[3] 元唯安 唐健元 邹冲[6] TANG Ya-qin;YANG Zhong-qi;TANG Zhao-an;YUAN Wei-an;TANG Jian-yuan;ZOU Chong(the First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China;Guangdong Clinical Research Academy of Chinese Medicine,Guangzhou 510405,China;the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,Changsha 410007,China;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China;Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China;Jiangsu Province Hospital of Traditional Chinese Medicine,Nanjing 210029,China)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405 [2]广东省中医临床研究院,广东广州510405 [3]湖南中医药大学第一附属医院,湖南长沙410007 [4]上海中医药大学附属曙光医院,上海200021 [5]成都中医药大学附属医院,四川成都610075 [6]江苏省中医院,江苏南京210029

出　　处：《中国中药杂志》2024年第17期4801-4804,共4页China Journal of Chinese Materia Medica

基　　金：广东省中药监管科学研究基地项目(2020JDB07);广东省中药人用经验临床评价技术重点实验室项目(2022ZDB06);广东省药品监督管理局科研项目(粤药监2023950);2023年度广东省中医药局科研平台专项(20233011,20233012)。

摘　　要：2023年2月国家药品监督管理局发布《中药注册管理专门规定》,明确提出鼓励在中医临床实践过程中开展高质量的人用经验研究,获得支持中药注册的充分证据;同时提出人用经验研究应符合相关要求,并接受药品注册核查。为规范中药人用经验研究,获取高质量支持注册申请的人用经验数据,促进研究规范化和标准化,按照国家相关法律法规和国家药品监督管理局药品审评中心人用经验研究技术指导原则要求,充分考虑中医药临床特点,中国药学会中药临床评价专业委员会组织制定《中药人用经验研究质量管理指南》,包括开展人用经验研究医疗机构条件、研究者、申办者、药学关键信息及要求、研究方案、伦理审查要点、研究实施过程的要求、人用经验研究风险管理与受试者保护等内容。该文件经过专家多轮征求意见,最终形成适用于支持药品注册的中药人用经验研究指南性文件,用以指导规范开展中药人用经验研究。National Medical Products Administration released the Special provisions on the administration of registration of traditional Chinese medicine(TCM)in February 2023,encouraging high-quality human use experience(HUE)study in TCM clinical practice to obtain sufficient evidence for TCM registration support.The provisions suggested that the HUE study should meet the relevant requirements and accept the drug registration verification.This paper aims to standardize the HUE study,obtain high-quality HUE data to support registration applications,and promote the standardization of research.In accordance with the relevant laws and regulations of the state and the requirements of the technical guidelines for the HUE study in the drug review center of the National Medical Products Administration,the clinical characteristics of TCM were considered,and the Clinical Evaluation Committee of Traditional Chinese Medicine of the Chinese Pharmaceutical Association organized and formulated the Guidelines for quality control of human use experience study on traditional Chinese medicine,including the conditions of medical institutions carrying out HUE study,researchers,sponsors,key information and requirements of pharmacy,research programs,key points of ethical review,requirements of the research imple-mentation process,risk management,and subject protection of HUE study.After several rounds of consultation with experts,a guideline document suitable for supporting drug registration and guiding HUE study on TCM was finally formed.

关 键 词：人用经验 质量管理 指南 

分 类 号：R288[医药卫生—中药学]