建立国家药品标准复审制度的思考与建议  

Thinking and Suggestion on Establishment of National Drug Standard Review System

作　　者：赵宇新[1] 麻广霖[1] ZHAO Yu-xin;MA Guang-lin(Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]国家药典委员会,北京100061

出　　处：《中国实验方剂学杂志》2020年第16期205-209,共5页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：分析在国家药品标准工作中建立复审制度的必要性,为完善国家药品标准工作提供建议。系统分析和总结国家药品标准工作中存在的问题,阐述标准复审制度的目的和意义,总结其他行业实施标准复审制度的情况。目前,国家药品标准工作中存在着工作机制不健全、标准提高工作进展不理想、生产企业对国家标准工作参与度过低、尚未建立顺畅的标准淘汰机制等问题。在国家药品标准工作中实施标准复审制度符合标准管理的客观规律,有助于改善国家药品标准工作的顶层设计、解决药品标准工作中的诸多瓶颈问题、实现药品标准的动态管理、促进药品上市后再评价工作。总而言之,建立和实施标准复审制度,有利于促进国家药品标准工作的发展。The necessity of establishing the review system in the administration of national drug standards was analyzed,in order to provide suggestions for improving the national drug standard work. The problems existed in national drug standard administration were analyzed and summarized,the purpose and significance of standard review system was analyzed,and the implementation of standard review system in other industries was reviewed. At present,there are some problems in the administration of national drug standards,such as imperfect working mechanism, unsatisfactory progress in the improvement of standards, low participation of manufacturers in the work of national standards,and unsmooth elimination mechanism of standards. The establishment of standard review system in national drug standard administration conforms to the objective law of standard management,which is helpful to improve the top-level design of national drug standard activities,solve the bottleneck problems in the durg standard work,realize the dynamic management of national drug standard,and promote the re-evaluation work of drugs after being put on the market. In a word,the establishment and implementation of the standard review system is conducive to the development of national drug standards.

关 键 词：药品标准 《中国药典》 复审制度 淘汰机制 参与度 

分 类 号：R22[医药卫生—中医基础理论] C65[医药卫生—中医学]