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中药卓越监管体系的构建策略与前景展望

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伴随着中药工业化、现代化、国际化进程,中药监管体系构建与能力提升正处在全球化监管合作与监管协调发展的战略机遇期.加快打造具有中国特色、符合中药特点、全球领先的中药卓越监管体系是我国构建"科学、高效、权威"药品监管体系战略的重要组成部分,是中国式现代化药品监管实践的新要求,是统筹高水平安全监管和产业高质量发展的新举措.中药卓越监管体系作为新时代赋予药监人的新任务和新目标,其构建策略可概括为3个层次、5个维度和3个机制:要聚焦中国特色、中药特点、全球领先3个层次进行立体布局,要综合法规制度、组织机构、科技支撑、产业发展、国际影响5个维度进行系统设计,要围绕中药全链条监管工作协调会商机制、中药监管科学研究者联盟工作机制及中药监管全球化政策协调机制3个工作进行方法创新,强化基础学科向监管应用转化,支持中药科学监管决策,推进高质量中药传承创新发展和高水平中药监管国际合作协调.
Strategies and Prospects for Building an Excellent Regulatory System for Traditional Chinese Medicine
With the industrialization,modernization,and internationalization of traditional Chinese medicine(TCM),the regulatory system of TCM is currently experiencing a strategic opportunity to enhance global regulatory cooperation and coordination capabilities.Accelerating the development of a global leading TCM excellent regulatory system(TCM-ERS)with Chinese characteristics and in line with TCM's unique features is an important part of China's strategy to build a"scientific,efficient and authoritative"drug regulatory system.It represents a new requirement for drug regulatory practices in Chinese-style modernization and a novel measure to coordinate high-level safety regulation with high-quality industrial development.The construction strategy of TCM-ERS,as a new task and goal assigned to drug regulatory authorities in the new era,can be summarized into three aspects:(1)a three-dimensional layout around three levels:Chinese characteristics,TCM characteristics,and global leadership.(2)a system from five dimensions:laws and regulations,organizational structure,technological support,industrial development,and international influence.(3)three working mechanisms:a TCM full chain coordination and consultation mechanism(TCM-FCCCM),a TCM regulatory science coalition mechanism(TCM-RSCM)and a TCM global policy coordination and regulation mechanism(TCM-GPCRM).Furthermore,it supports the transformation of basic disciplines into regulatory applications,assist scientific regulatory decision-making,and promote the inheritance and innovation of TCM.

traditional Chinese medicine(TCM)TCM regulatory scienceTCM excellent regulatory systembuilding strategiesdevelopment prospects

赵军宁

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国家药品监督管理局药品监管科学全国重点实验室

中药 中药监管科学 中药卓越监管体系 构建策略 前景展望

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(2)
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