中药药理与临床2025，Vol.41Issue(1)：12-17,6.
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
王停 1张俊华 2唐健元 3杨忠奇 4李平 5张声生 6华桦 7任武贤 8李锋 9周水平 10周贝 11王琦 1马秀璟 11薛斐然 11唐志书 1吕泽 12刘春 13于江泳 14王海南 14赵军宁 15仝小林 16李梢 17周思源 11马双成 18李馨龄 19叶祖光 20谢晓余21
作者信息
- 1. 北京中医药大学,北京 100029
- 2. 天津中医药大学,天津 301617
- 3. 成都中医药大学附属医院,成都 610000
- 4. 广州中医药大学第一附属医院,广州 510000
- 5. 中日友好医院,北京 100029
- 6. 首都医科大学附属北京中医医院,北京 100010
- 7. 四川省中医药转化医学中心,成都 610041
- 8. 亚宝药业集团股份有限公司,山西 044000
- 9. 瑞阳制药股份有限公司,山东 256100
- 10. 天士力医药集团股份有限公司,天津 300000
- 11. 国家药品监督管理局药品审评中心,北京 100037
- 12. 国家中医药管理局中药科技与发展处,北京 100010
- 13. 国家药品监督管理局药品监管司,北京 100037
- 14. 国家药品监督管理局药品注册司,北京 100037
- 15. 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
- 16. 中国中医科学院广安门医院,北京 100053
- 17. 清华大学,北京 100084
- 18. 国家药典委员会,北京 100061
- 19. 国家药品监督管理局药品评价中心,北京 100076
- 20. 中国中医科学院中药研究所,北京 100700
- 21. 中国中医科学院中药监管科学中心,北京 100700
- 折叠
摘要
Abstract
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 Labo-ratory 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 sum-mary.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 deliv-ered by Academician Wang Qi from Beijing University of Chinese Medicine and Professor Li Shao,Director of the Institute of TCM-X at Tsing-hua 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,uni-versities,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 Acad-emician 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 provide new ideas and methods for the development and regulation of new TCM drugs for preventive treatment,and to offer strong support for advancing the research,development,and scientific regulation of these drugs in China.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Key words
Preventive treatment of diseases/New drug research and development/Traditional Chinese medicine regulatory science/New ide-as/New tools/New standards/New methods引用本文复制引用
王停,张俊华,唐健元,杨忠奇,李平,张声生,华桦,任武贤,李锋,周水平,周贝,王琦,马秀璟,薛斐然,唐志书,吕泽,刘春,于江泳,王海南,赵军宁,仝小林,李梢,周思源,马双成,李馨龄,叶祖光,谢晓余..基于治未病的中药新药研制与监管科学问题探讨[J].中药药理与临床,2025,41(1):12-17,6.
