中药药理与临床2025，Vol.41Issue(1)：2-5,4.
中药监管科学研究者联盟(TCMRSC)工作机制
Working Mechanism Meeting of the TCM Regulatory Science Coalition
于江泳 1刘春 2马双成 3王海南 1王停 4张俊华 5唐健元 6华桦 7耿兴超 8阳长明 9宋海波 10蒋露11
作者信息
- 1. 国家药品监督管理局药品注册司,北京 100037
- 2. 国家药品监督管理局药品监管司,北京 100037
- 3. 国家药典委员会,北京 100061
- 4. 北京中医药大学,北京 100029
- 5. 天津中医药大学,天津 301617
- 6. 成都中医药大学附属医院,成都 610000
- 7. 四川省中医药转化医学中心,成都 610041
- 8. 中国食品药品检定研究院,北京 100050
- 9. 国家药品监督管理局药品审评中心,北京 100037
- 10. 国家药品监督管理局药品评价中心,北京 100076
- 11. 国家药品监督管理局科技国合司,北京 100037
- 折叠
摘要
Abstract
In accordance with the"Implementation Plan for Strengthening the Construction of a Scientific Regulatory System for Drug Supervision"issued by the National Medical Products Administration,which calls for the establishment of a collaborative innovation system for regulatory science with leadership from drug regulatory authorities and comprehensive participation from society,as well as the deployment requirements from the 2024 National Conference on Drug Supervision and Management regarding the establishment of a new mechanism for transforming sci-entific research in the regulation of traditional Chinese medicine(TCM),the working mechanism of the TCM Regulatory Science Coalition(TCMRSC)has been established with the joint efforts of experts and scholars from government,industry,academia,and research institutions in the fields of TCM technological innovation and regulation.Adhering to the principles of"equality,freedom,openness,collaboration,effi-ciency sharing,and integrated innovation",this platform provides a non-profit,purely academic exchange platform for TCM regulatory science research,offering intellectual support and inspiration for the development of TCM regulatory science.To date,the TCMRSC working mecha-nism has successfully held three specialized working meetings,focusing on TCM regulatory science issues such as"substitutes for rare and en-dangered medicinal materials","feeding herbal extracts","new drug development based on preventive treatment of diseases",and"key sci-entific issues in clinical translation of the new traditional Chinese medicine drugs for syndromes".These discussions are of significant impor-tance for accelerating the progress of TCM regulatory science research,speeding up the transformation and market entry of emerging TCM products,and enhancing the scientific regulatory level of TCM.关键词
中药监管科学/中药监管科学研究者联盟/工作机制/专题会议/珍稀濒危中药材替代品/中药提取物投料/治未病中药新药/证候类中药新药引用本文复制引用
于江泳,刘春,马双成,王海南,王停,张俊华,唐健元,华桦,耿兴超,阳长明,宋海波,蒋露..中药监管科学研究者联盟(TCMRSC)工作机制[J].中药药理与临床,2025,41(1):2-5,4.
