国家药品标准物质保障供应的实施要点研究  

Key points on complement of continuous supply for national drug reference standards

作　　者：高志峰[1] 骆晨 刘明理[1] 赵宗阁[1] 王青[1] 孙会敏[1] GAO Zhi-feng;LUO Chen;LIU Ming-i;ZHAO Zong-ge;WANG Qing;SUN Hui-min(National Institute for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国新药杂志》2024年第3期216-220,共5页Chinese Journal of New Drugs

基　　金：国家食品药品监督管理总局委托研究课题:药品检验机构能力建设标准研究(M201404)。

摘　　要：标准物质是药品检定的重要物质基础,国家药品标准物质由中国食品药品检定研究院组织研制、标定和供应。近年来随着公众对健康需求的逐年提升,药品标准和药品检验技术水平逐渐提高,标准物质品种的数量也大幅增长,保障全品种供应的难度陡增,供应率一直维持在96%。为解决4%的紧缺差距,中国食品药品检定研究院通过疏导研制过程中的堵点和卡点,制定预警监测和精准供应双举措,最终在2022年7月首次实现了标准物质全品种100%保供。本文通过对用户需求数据进行分析,对标准物质的研制全链条进行梳理,对流程各环节所需时限进行统计,研究得出标准物质品种的需求速度、预警周期以及精准供应方法,从而构建了标准物质的接续供应循环体系,并提出持续优化循环体系的关键指标、建立智能需求反馈系统、构建协同模式推进动态100%保供等措施,为进一步提高标准物质管理的工作效率提供参考。Reference standards are the important material basis for drug control,and legal distribution of the national drug reference standards is one of the basic functions of NIFDC.In recent years,with the increasing public health demand,the level of Drug standards and Drug inspection technology has gradually improved,making the number of reference standards increase significantly.It is difficult to ensure the supply of all varieties,resulting in the supply rate maintained at 96%.In order to solve the shortage gap of 4%,NIFDC has developed two measures of early warning monitoring and accurate supply by dredging the blocking points and sticking points in the development process.Finally,100%guaranteed supply of all kinds of reference standards is going to be achieved in July 2022 for the first time.This paper analyzes the user demand data,combs the whole chain of the development of reference standards,makes statistics on the time limit required for each link of the process,and studies the demand speed and early warning cycle of reference standards,as well as precise supply methods,so as to build a continuous supply cycle system of reference standards.This paper also puts forward measures to continuously optimize the key indicators of the circulation system,establishes an intelligent demand feedback system,builds a collaborative model to promote dynamic 100%%o guaranteed supply,providing reference for further improving the efficiency of reference standards management.

关 键 词：药品 标准物质 供应 

分 类 号：R95[医药卫生—药学]