基于治未病的中药新药研制与监管科学问题探讨  

Discussion on Scientific Issues Related to the Development and Regulation of New Chinese Medicine Based on Preventive Treatment of Diseases

作　　者：王停[1] 王琦[1] 仝小林[2] 李梢[3] 周思源 马双成 李馨龄 叶祖光[7] 谢晓余 张俊华[9] 唐健元 杨忠奇[11] 李平[12] 张声生[13] 华桦 任武贤 李锋 周水平 周贝 马秀璟 薛斐然 唐志书 吕泽 刘春 于江泳 王海南 赵军宁 WANG Ting;WANG Qi;TONG Xiaolin;LI Shao;ZHOU Siyuan;MA Shuangcheng;LI Xinling;YE Zuguang;XIE Xiaoyu;ZHANG Junhua;TANG Janyan;YAN Zhongqi;LI Ping;ZHANG Shenheng;HUA Hua;REN Wuxian;LI Feng;ZHOU Shuiping;ZHOU Bei;MA Xiujing;XUE Feiran;TANG Zhishu;LV Ze;LIU Chun;YU Jiangyong;WANG Hainan;ZHAO Junning(Beijing University of Chinese Medicine,Beijing 100029;Guang'anmen Hospital of the China Academy of Chinese Medical Sciences,Beijing 100053;Tsinghua University,Beijing 100084;Center for Drug Evaluation,National Medical Products Administration,Beijing 100037;National Pharmacopoeia Commission,Beijing 100061;National Center for Drug Evaluation,National Medical Products Administration,Beijing 100076;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700;Center for Regulatory Science of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700;Tianjin University of Traditional Chinese Medicine,Tianjin 301617;Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610000;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Chuangzhou 510000;China-Japan Friendship Hospital,Beijing 100029;Bejing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 10010;Sichuan Institute for Translational Chinese Medicine,Chengdu 610041;Yabao Pharmaceutical Group Co.,Ltd.,Shanxi 044000;Reyoung Pharmaceutical Co.,Ltd.,Shandong 256100;Tasly Pharmaceutical Group Co.,Ltd.,Tianjin 300000;Science and Technology Development Division of TCM,National Administration of Traditional Chinese Medicine,Beijing 100010;Department of Drug Supervision,National Medical Products Administration,Beijing 100037;Department of Drug Registration,National Medical Products Administration,Beijing 100037;National Medical Products Administration,National Key Laboratory for Drug Regulatory Science,Beijing 100037)

机构地区：[1]北京中医药大学,北京100029 [2]中国中医科学院广安门医院,北京100053 [3]清华大学,北京100084 [4]国家药品监督管理局药品审评中心,北京100037 [5]国家药典委员会,北京100061 [6]国家药品监督管理局药品评价中心,北京100076 [7]中国中医科学院中药研究所,北京100700 [8]中国中医科学院中药监管科学中心,北京100700 [9]天津中医药大学,天津律301617 [10]成都中医药大学附属医院,成都610000 [11]广州中医药大学第一附属医院,广州510000 [12]中日友好医院,北京100029 [13]首都医科大学附属北京中医医院,北京100010 [14]四川省中医药转化医学中心,成都610041 [15]亚宝药业集团股份有限公司,山西044000 [16]瑞阳制药股份有限公司,山东256100 [17]天士力医药集团股份有限公司,天津300000 [18]国家中医药管理局中药科技与发展处,北京100010 [19]国家药品监督管理局药品监管司,北京100037 [20]国家药品监督管理局药品注册司,北京100037 [21]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12-17,共6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)工作机制第二次专题工作会议(TCMRSC 24-2)于2024年10月25日在北京中医药大学和平街校区召开。会议由北京中医药大学国家药品监督管理局中医药研究与评价重点实验室承办,主题为“基于治未病的中药新药研制与监管科学问题探讨”,北京中医药大学王停教授主持会议。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。第二部分由中国中医科学院仝小林院士主持,北京中医药大学王琦院士、清华大学北京市中医药交叉研究所所长李梢教授进行主旨报告,分享了治未病类中药新药研发的多元临床价值及已取得的学术成果。第三部分来自政府部门、高校、科研院所、临床医院、企业的30余名专家围绕“基于治未病的中药新药研制与监管科学问题探讨”进行专题研讨。第四部分仝小林院士进行专题研讨总结。与会专家围绕治未病类中药新药研发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,希望能为治未病类中药新药研发和监管提供新思路和新方法,为推动我国治未病类中药新药研发和科学监管提供有力支撑。The second special working meeting of the TCM Regulatory Science Coalition(TCMRSC)working mechanism(TCMRSC 24-2)was held on October 25,2024,at the Beijing University of Chinese Medicine,Heping Street campus.The meeting was organized by the Key Laboratory of Traditional Chinese Medicine Research and Evaluation under the National Medical Products Administration at Beijing University of Chinese Medicine.The theme of the meeting was"Exploring Development and Regulatory Science Challenges in New Traditional Chinese Medicine Drugs Based on Preventive Treatment of Diseases".The meeting was chaired by Professor Wang Ting from Beijing University of Chinese Medicine.The meeting was divided into four parts:background introduction,keynote reports,specialized discussion,and meeting summary.The first part,background introduction,was presented by Researcher Zhao Junning from the National Medical Products Administration.The second part was chaired by Academician Tong Xiaolin from the China Academy of Chinese Medical Sciences,with keynote reports delivered by Academician Wang Qi from Beijing University of Chinese Medicine and Professor Li Shao,Director of the Institute of TCM-X at Tsinghua University.They shared insights into the diverse clinical values and academic achievements in the development of new TCM drugs for preventive treatment.The third part of the meeting featured a specialized discussion,with over 30 experts from government departments,universities,research institutes,clinical hospitals,and enterprises.The discussion focused on the development and regulatory science challenges of new TCM drugs based on preventive treatment of diseases.The fourth part concluded with a summary of the discussion,presented by Academician Tong Xiaolin.The experts engaged in broad and in-depth discussions on the scientific issues related to the research,development,and regulation of new TCM drugs for preventive treatment of diseases.This article organizes the key perspectives and recommendations put forward by the experts,aiming to provid

关 键 词：治未病 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]