我国部分地区药品零售连锁监管政策分析  

Analysis of Drug Retail Chain Supervision Policy in Some Regions of China

作　　者：张磊 ZHANG Lei(Fujian Center for Drug Inspection)

机构地区：[1]福建省药品审核查验中心

出　　处：《中国食品药品监管》2025年第2期78-91,共14页China Food & Drug Administration Magazine

摘　　要：本文通过检索省级药品监管部门网站,汇总了我国13个地区有关药品零售连锁监管政策,并通过横向与纵向对比方式,对不同地区在药品连锁总部门店数量准入标准、仓储准入标准、委托配送、门店间药品调拨、网络销售、兼并重组、连锁总部停业期间门店药品的处理、电子化首营资料和配送清单、药品“批零一体”发展9个方面的差异和共性进行了分析。同时探讨了当前出现的药品“批零一体”监管要求不明确、连锁总部企业无序发展、连锁总部委托储存配送部分监管要求不明确、连锁门店缺乏规范化管理等问题,并进行了相关思考,以期为制定和持续优化药品零售连锁监管政策提供参考。This paper collected regulatory policies pertaining to drug retail chains in 13 regions by examining the websites of provincial drug administration departments.It analyzes the differences and commonalities among these regions in nine key aspects:entry standards for the total number of chain store branches;entry criteria for chain headquarters'warehousing;commissioned distribution;inter-store drug transfers;online sales of drugs by chain stores;mergers and acquisitions;handling of drugs in chain stores during the temporary closure of headquarters;electronic initial sale information and distribution lists;and the integrated development of drug wholesale and retail.The study also discusses emerging regulatory requirements for integrated pharmaceutical wholesale and retail,disorderly growth of chain headquarters,unclear guidelines for entrusted storage and distribution by chain headquarters,and the lack of standardized management of individual chain stores.Relevant reflections and recommendations are proposed with the aim of informing the formulation and continuous optimization of drug retail chain regulatory policies.

关 键 词：药品零售连锁 法规政策 监管 标准 对比 

分 类 号：R95[医药卫生—药学]