北京中医药大学学报2025，Vol.48Issue(4)：445-450,6.DOI:10.3969/j.issn.1006-2157.2025.04.001
"三结合"注册审评证据体系的定位及"人用经验"价值取向的专家共识
Expert consensus on the positioning of the"Three-in-One"Registration and Evaluation Evidence System and the value of orientation of the"personal experience"
摘要
Abstract
Traditional Chinese Medicine(TCM),as a treasure of the Chinese nation,plays a significant role in maintaining public health.In 2019,the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory,"personal experience"and clinical trials(referred to as the"Three-in-One"System)to promote the inheritance and innovation of TCM.Subsequently,the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system.Owing to the complexity of its implementation,there are still differing understandings within the TCM industry regarding the positioning of the"Three-in-One"Registration and Evaluation Evidence System,as well as the connotation and value orientation of the"personal experience."To address this,Academician WANG Qi,President of the TCM Association,China International Exchange and Promotion Association for Medical and Healthcare and TCM master,led a group of academicians,TCM masters,TCM pharmacology experts and clinical TCM experts to convene a"Seminar on Promoting the Implementation of the'Three-in-One' Registration and Evaluation Evidence System for Chinese Medicinals."Through extensive discussions,an expert consensus was formed,clarifying the different roles of the TCM theory,"personal experience"and clinical trials within the system.It was further emphasized that the"personal experience"is the core of this system,and its data should be derived from clinical practice scenarios.In the future,the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.关键词
三结合/人用经验/临床试验/专家共识Key words
Three-in-One/personal experience/clinical trials/expert consensus分类
医药卫生引用本文复制引用
王琦,梅国强,沈宝藩,王庆国,王晞星,南征,韩明向,高月,肖小河,孙晓波,胡凯文,王永炎,贾立群,冯利,吴承玉,丁霞,肖伟,田金洲,陈士林,朱立国,孙光荣,张大宁,周岱翰.."三结合"注册审评证据体系的定位及"人用经验"价值取向的专家共识[J].北京中医药大学学报,2025,48(4):445-450,6.基金项目
中国工程院战略研究与咨询项目(No.2024-XZ-65) Strategic Research and Consulting Project of Chinese Academy of Engineering(No.2024-XZ-65) （No.2024-XZ-65）
