中药药理与临床2025，Vol.41Issue(1)：17-21,5.
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
唐健元 1王云峰 2谢春光 1杨子峰 3杨忠奇 4王忠 5王保和 6林生 7夏结来 8张磊 9边宝林 10于江泳 11李明权 1丁红 1华桦 12彭涛 13刘晖晖 14杜莹洁 15王京昆 16王丹 17王智磊 1侯晨晨 18杨正林 19米银军 20李在伟 21马忠明 22秦晓岺 23赵军宁 24朱兆云 25熊大经 1余曙光 26王停 27彭成 26舒红平28
作者信息
- 1. 成都中医药大学附属医院,成都 610075
- 2. 中国科学院微电子研究所,北京 100029
- 3. 广州医科大学呼吸疾病国家重点实验室,广州 510120
- 4. 广州中医药大学第一附属医院,广州 510000
- 5. 中国中医科学院临床基础所,北京 100700
- 6. 天津中医药大学第一附属医院,天津 300381
- 7. 北京中医药大学东直门医院,北京 101121
- 8. 空军军医大学军事预防医学系,西安 710032
- 9. 上海中医药大学协同创新中心,上海 201203
- 10. 中国中医科学院中药研究所,北京 100700
- 11. 国家药品监督管理局药品注册司,北京 100037
- 12. 四川省中医药转化医学中心,成都 610041
- 13. 重庆太极医药研究院,重庆 401147
- 14. 华润三九中医药研究院,成都 610093
- 15. 同仁堂研究院,北京 102399
- 16. 云南白药集团中央研究院,昆明 650111
- 17. 粤澳药业有限公司,珠海 519000
- 18. 国家药品监督管理局药品审评中心,北京 100076
- 19. 四川省医学科学院·四川省人民医院,成都 610072
- 20. 四川省中医药管理局,成都 610020
- 21. 四川省药品监督管理局,成都 610020
- 22. 国家中医药管理局科技司,北京 100027
- 23. 国家药品监督管理局科技和国际合作司,北京 100037
- 24. 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
- 25. 云南白药有限公司创新研发中心,昆明 650111
- 26. 成都中医药大学,成都 611137
- 27. 北京中医药大学,北京 100029
- 28. 成都信息工程大学,成都 610225
- 折叠
摘要
Abstract
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 Ex-ploration 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 Profes-sor 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 scien-tific issues in the clinical translation and regulation of syndrome-based TCM new drugs.This paper summarizes the main viewpoints and sug-gestions 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Key words
Syndrome-based TCM new drugs/New drug development/TCM regulatory science/New perspectives/New tools/New stand-ards/New methods引用本文复制引用
唐健元,王云峰,谢春光,杨子峰,杨忠奇,王忠,王保和,林生,夏结来,张磊,边宝林,于江泳,李明权,丁红,华桦,彭涛,刘晖晖,杜莹洁,王京昆,王丹,王智磊,侯晨晨,杨正林,米银军,李在伟,马忠明,秦晓岺,赵军宁,朱兆云,熊大经,余曙光,王停,彭成,舒红平..证候类中药新药临床转化关键科学问题探讨[J].中药药理与临床,2025,41(1):17-21,5.
