证候类中药新药临床转化关键科学问题探讨  

Exploration of Key Scientific Issues in Clinical Translation of Syndrome-Based TCM New Drugs

作　　者：唐健元 于江泳 杨正林[3] 朱兆云 熊大经[1] 余曙光[5] 王停[6] 彭成[5] 舒红平[7] 王云峰[8] 谢春光[1] 杨子峰[9] 杨忠奇[10] 王忠[11] 王保和[12] 林生 夏结来 张磊[15] 边宝林[16] 李明权[1] 丁红[1] 华桦 彭涛 刘晖晖 杜莹洁 王京昆 王丹 王智磊 侯晨晨 米银军 李在伟 马忠明 秦晓岺 赵军宁 TANG Jianyuan;YU Jiangyong;YANG Zhenglin;ZHU Zhaoyun;XIONG Dajing;YU Shuguang;WANG Ting;PENG Cheng;SHU Hongping;WANG Yunfeng;XIE Chunguang;YANG Zifeng;YANG Zhongqi;WANG Zhong;WANG Baohe;LIN Sheng;XIA Jielai;ZHANG Lei;BIAN Baolin;LI Mingquan;DING Hong;HUA Hua;PENG Tao;LIU Huihui;DU Yingjie;WANG Jingkun;WANG Dan;WANG Zhilei;HOU Chenchen;MI Yinjun;LI Zaiwei;MA Zhongming;QIN Xiaoling;ZHAO Junning(Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610075;Department of Drug Registration,National Medical Products Administration,Beijing 100037;Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital,Chengdu 610072;Innovation and Research Center of Yunnan Baiyao Group Co.,Ltd.,Kunming 650111;Chengdu University of Traditional Chinese Medicine,Chengdu 611137;Beijing University of Chinese Medicine,Beijing 100029;Chengdu University of Information Technology,Chengdu 610225;Institute of Microelectronics,Chinese Academy of Sciences,Beijing 100029;State Key Laboratory of Respiratory Diseases,Guangzhou Medical University,Guangzhou 510120;The First Affliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510000;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381;Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 101121;Department of Military Preventive Medicine,Air Force Medical University,Xi'an 710032;Shanghai Innovation Center of TCM Health Service,Shanghai University of Traditional Chinese Medicine,Shanghai 201203;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Bejing 100700;Sichuan Institute for Translational Chinese Medicine,Chengdu 610041;Chongqing Taiji Medical Research Institute,Chongqing 401147;Research Institute of Traditional Chinese Medicine,China Resources Sanjiu Pharmaceutical Co.,Ltd.,Chengdu 610093;Tongrentang Research Institute,Beijing 102399;Central Research Institute of Yu

机构地区：[1]成都中医药大学附属医院,成都610075 [2]国家药品监督管理局药品注册司,北京100037 [3]四川省医学科学院·四川省人民医院,成都邢610072 [4]云南白药有限公司创新研发中心,昆明月650111 [5]成都中医药大学,成都611137 [6]北京中医药大学,北京100029 [7]成都信息工程大学,成都610225 [8]中国科学院微电子研究所,北京100029 [9]广州医科大学呼吸疾病国家重点实验室,广州510120 [10]广州中医药大学第一附属医院,广州510000 [11]中国中医科学院临床基础所,北京100700 [12]天津中医药大学第一附属医院,天津津300381 [13]北京中医药大学东直门医院,北京101121 [14]空军军医大学军事预防医学系,西安安710032 [15]上海中医药大学协同创新中心,上海201203 [16]中国中医科学院中药研究所,北京100700 [17]四川省中医药转化医学中心,成都610041 [18]重庆太极医药研究院,重庆401147 [19]华润三九中医药研究院,成都610093 [20]同仁堂研究院,北京102399 [21]云南白药集团中央研究院,昆明650111 [22]粤澳药业有限公司,珠海519000 [23]国家药品监督管理局药品审评中心,北京100076 [24]四川省中医药管理局,成都610020 [25]四川省药品监督管理局,成都610020 [26]国家中医药管理局科技司,北京100027 [27]国家药品监督管理局科技和国际合作司,北京100037 [28]国家药品监督管理局、药品监管科学全国重点实验室,北京100037

出　　处：《中药药理与临床》2025年第1期17-21,共5页Pharmacology and Clinics of Chinese Materia Medica

摘　　要：中药监管科学研究者联盟(TCM Regulatory Science Coalition, TCMRSC)工作机制2024年第三次专题工作会议(TCMRSC24-3)于2024年11月28日在成都召开。会议由成都中医药大学附属医院发起并承办,主题为“证候类中药新药临床转化关键科学问题探讨”,唐健元教授主持会议。会议分为背景介绍、主旨报告、专题研讨、会议总结四个部分进行。第一部分由国家药品监督管理局赵军宁研究员进行背景介绍。第二部分由四川省医学科学院·四川省人民医院杨正林院士主持,云南白药有限公司创新研发中心研发总监朱兆云院士、成都中医药大学附属医院唐健元进行主旨报告,分享了证候类中药新药研究临床试验认识和体会,以及探讨证候类中药新药临床转化关键科学问题和已取得的学术成果。第三部分来自政府部门、高校、科研院所、医院、企业的40余名专家围绕证候类中药临床试验方法、证候类中药研究质量控制和证候类中药临床疗效评价进行专题研讨。第四部分由国家药品监督管理局科技和国际合作司司长秦晓岺进行专题研讨总结。与会专家围绕证候类中药新药临床转化和监管中的相关科学问题进行了广泛、深入的讨论,本文整理了专家们的主要观点和建议,希望能为证候类中药新药临床转化和监管提供新思路和新方法,为推动我国证候类中药新药临床转化和科学监管提供有力支撑。The third thematic working meeting of the Traditional Chinese Medicine Regulatory Science Coalition( TCMRSC 24-3) was held in Chengdu on November 28,2024. Hosted by the Hospital of Chengdu University of Traditional Chinese Medicine,the meeting focused on Exploration of Key Scientific Issues in the Clinical Translation of Syndrome-based TCM New Drugs and was chaired by Professor Tang Jianyuan.The meeting was structured into four parts: background introduction,keynote presentations,thematic discussions,and meeting summary. The first part featured a background introduction by Dr. Zhao Junning from the National Medical Products Administration. The second part,chaired by Academician Yang Zhenglin from the Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital,included keynote presentations by Academician Zhu Zhaoyun from the Innovation and Research Center of Yunnan Baiyao Group Co.,Ltd. and Professor Tang Jianyuan,who shared insights on the key scientific issues and academic achievements in the clinical translation of syndrome-based TCM new drugs. The third part involved over 40 experts from the government,colleges and universities,research institutions,hospitals,and enterprises,who discussed the clinical trial methods,quality control,and clinical efficacy evaluation of syndrome-based TCM new drugs. The fourth part was a summary of the thematic discussions by Qin Xiaoling,director of the Department of Science,Technology and International Cooperation,National Medical Products Administration. The attending experts conducted extensive and in-depth discussions on related scientific issues in the clinical translation and regulation of syndrome-based TCM new drugs. This paper summarizes the main viewpoints and suggestions of the experts,aiming to provide new perspectives and methods for the clinical translation and regulation of syndrome-based TCM new drugs,thereby offering robust support for their development and scientific regulation in China.

关 键 词：证候类中药新药 新药研发 中药监管科学 新思路 新工具 新标准 新方法 

分 类 号：R288[医药卫生—中药学]