基于问题导向的国家药品抽检计划设计方法探讨  

Discussion of Design Method of National Drug Sampling and Testing Plan Based on Problem Orientation

作　　者：朱嘉亮[1] 陈蕾[2] 王翀[1] 朱炯[1] ZHU Jialiang;CHEN Lei;WANG Chong;ZHU Jiong(National Institute for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药典委员会,北京100061

出　　处：《医药导报》2023年第3期436-442,共7页Herald of Medicine

摘　　要：目的通过分析讨论国家药品抽检计划,提出可行优化举措和建议,推动药品抽检管理模式创新。方法从国家药品抽检计划的制定原则、方法程序、存在问题等方面进行介绍,重点讨论如何对品种遴选、抽样层级划分、检验专项设计,以及购样环节进行科学合理的设计规划。结果将风险管理理念融入品种遴选,探索精准抽样模式,通过深度数据挖掘确定监管重点,建立周期性回顾机制,动态更新抽检方案。结论药品质量抽查检验是上市后药品监管的重要手段之一,必须从顶层设计入手,以问题为导向,制定科学合理的计划方案,才能提高抽检效能,为加强药品监管提供技术支持。Objective To analyze and discuss the national drug sampling and testing plan based on the problem-oriented approach and to put forward feasible optimization measures and suggestions to promote the innovation of drug sampling management mode.Methods This article introduced the principles,methods,procedures,and existing problems of the national drug sampling and testing plan,and discussed how to carry out scientific and reasonable design planning for the selection principle of varieties,the classification of sampling levels,the design of special inspection projects,and the purchase of samples.Results Integrated risk management concept was introduced into variety selection,to explore accurate sampling mode.The regulatory priorities were determined through in-depth data mining to establish a periodic review mechanism and dynamically update the sampling scheme.Conclusion Drug quality sampling inspection is one of the important means of post-marketing supervision.It is necessary to start from the top-level design,formulate a scientific and reasonable plan based on problem orientation,to improve the efficiency of drug sampling,and provide technical support for strengthening drug supervision.

关 键 词：国家药品抽检 计划制定 设计方法 问题导向 

分 类 号：R95[医药卫生—药学]