关于《中药标准管理专门规定》的解读与思考  

Interpretation and Reflection of Special Regulations on the Management of Traditional Chinese Medicine Standards

作　　者：赵宇新[1,5] 汪祺 顾杰[3] 何轶 于江泳 王海南 马双成 赵军宁 ZHAO Yuxin;WANG Qi;GU Jie;HE Yi;YU Jiangyong;WANG Hainan;MA Shuangcheng;ZHAO Junning(Chinese Pharmacopeia Commission,Beijing 100061,China;National Institutes for Food and Drug Control,Beijing 102629,China;Center for Drug Evaluation NMPA,Beijing 100076,China;National Medical Products Administration,Beijing 100037,China;State Key Laboratory of Drug Regulation Science,Beijing 100061,China)

机构地区：[1]国家药典委员会,北京100061 [2]中国食品药品检定研究院,北京102629 [3]国家药品监督管理局药品审评中心,北京100076 [4]国家药品监督管理局,北京100037 [5]药品监管科学全国重点实验室,北京100061

出　　处：《中国药学杂志》2025年第2期109-113,共5页Chinese Pharmaceutical Journal

摘　　要：目的 对《中药标准管理专门规定》有关情况进行说明,提出中药标准工作的建议。方法 对《中药标准管理专门规定》的主要内容进行分析,概况其主要特点,梳理后续应开展的有关工作。结果 《中药标准管理专门规定》在构建符合中医药特点的标准体系、优化中药标准工作机制、明确各方工作责任以及完善中药标准技术体系等方面做出积极探索。结论 应进一步加强中药标准工作机制建设,完善中药标准相关技术要求,加强各类标准间的协调。OBJECTIVE To explain the main content of the Special Regulations on the Management of Traditional Chinese Medicine Standards and propose suggestions on management of traditional Chinese medicine standards.METHODS The main content and key features of the Special Regulations on the Management of Traditional Chinese Medicine Standards was analyzed,and the suggestions were proposed to strengthen the management of traditional Chinese medicine standards.RESULTS The Special Regulations on the Management of Traditional Chinese Medicine Standards was focused on the reform of mechanism of management of Chinese medicine standards,such as building standard system that conforms to the key characteristics of traditional Chinese medicine,optimizing the management program of traditional Chinese medicine standards,clarifying the responsibilities of interested parties,and improving the technical system of traditional Chinese medicine standards.CONCLUSION The mechanism for traditional Chinese medicine standards should be optimized,the technical requirements related to traditional Chinese medicine standards should be improved,and all kinds of standards should be coordinated.

关 键 词：中药标准 中药标准管理专门规定 标准工作机制 

分 类 号：R95[医药卫生—药学]