中药监管科学驱动下的四川中药产业高质量发展新策略  

New Strategy of High-quality Development of TCM Industry in Sichuan Driven by TCM Regulatory Science

作　　者：华桦 方清茂 李青苗 唐健元 马双成[3,4] 赵军宁 Hua Hua;Fang Qingmao;Li Qingmiao;Tang Jianyuan;Ma Shuangcheng;Zhao Junning(Sichuan Institute for Translational Chinese Medicine,Sichuan Academy of Chinese Medicine Sciences.Key Laboratory of Biological Evaluation of Quality of Traditional Chinese Medicine,National Administration of Traditional Chinese Medicine,Key Laboratory of TCM Translational Medicine of Sichuan Province,Sichuan Daodi Medicine System Development Engineering Technology Research Center,Sichuan Engineering Research Center of Formation Principle and Quality Evaluation of Daodi Medicine,Chengdu 610041,China;Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610752,China;Institute for Control of Chinese Medicine and Ethnic Medicine,National Institutes for Food and Drug Control,Beijing 100050,China;National Medical Products Administration of China,National Key Laboratory of Drug Regulatory Science,Beijing 100037,China)

机构地区：[1]四川省中医药转化医学中心、四川省中医药科学院、国家中医药管理局中药质量生物评价重点研究室、中医药转化医学四川省重点实验室、四川省道地药材系统开发工程技术研究中心、四川省道地药材形成原理与品质评价工程研究中心,成都610041 [2]成都中医药大学附属医院,成都610752 [3]中国食品药品检定研究院中药民族药检定所,北京100050 [4]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：《世界科学技术-中医药现代化》2023年第7期2241-2247,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：2023年度国家药品监督管理局研究课题(2023366):中药监管科学战略研究,负责人:胡镜清;四川省中医药科技产业创新团队专项(2022C009):川产道地药材大健康产品开发与产业化创新团队,负责人:华桦;财政部国家中医药管理局2017年中央财政中医药部门公共卫生服务补助资金(Z135080000022),负责人:赵军宁。

摘　　要：中药监管科学(TCM regulatory science)作为评估受监管的中药材、中药饮片、中成药等中药产品的安全性、有效性、质量和风险获益综合性能的新兴融合科学,其核心是研发符合中药特点的新工具、新标准和新方法。中药监管科学在建立符合中医药特点的中药科学监管体系,加速中药新兴技术产品转化和促进中医药传承创新发展发挥重要的支撑作用。四川作为我国著名的“中医之乡,中药之库”,国家首个中药现代化科技产业基地和国家首批中医药综合改革示范区,在我国中药产业高质量发展具有示范和引领作用。本文基于中药监管科学新工具、新标准、新方法的最新进展,概述了中药监管科学在提高中药监管效能,加速中药新技术新产品转化应用和助推四川中药产业高质量发展的重要作用和前景,对于保障和提升中药监管能力和驱动中药产业健康发展具有重要意义。Traditional Chinese medicine(TCM)regulatory science,as an emerging interdisciplinary science,evaluates the safety,effectiveness,quality,and risk-benefit profile of regulated Chinese medicinal products,including Chinese medicinal materials,Chinese medicinal slices,and Chinese patent medicines.It highlights the development of new tools,standards,and methods that align with the unique characteristics of TCM.TCM regulatory science plays a crucial role in establishing a TCM scientific regulatory system that suits the features of TCM,accelerating the transformation of emerging TCM technologies and facilitating innovation in the inheritance and development of TCM.Sichuan,known as the"hometown of TCM therapies and the treasure trove of TCM",has built the first national modernized TCM technology industrial base and one of the first national comprehensive TCM reform demonstration zones.It plays a demonstrative and leading role in the high-quality development of the TCM industry in China.Based on the latest progress in new tools,standards,and methods of TCM regulatory science,this article overviewed its significant role and prospects in enhancing the efficiency of TCM regulation,accelerating the transformation and application of new TCM technologies and products,and promoting the high-quality development of the TCM industry in Sichuan.It is of great significance for ensuring and improving the regulatory capabilities of TCM and driving the healthy development of the TCM industry.

关 键 词：中药监管科学 川产道地药材 高质量发展 中药产业 四川省 

分 类 号：R288[医药卫生—中药学]