我国药品非现场检查制度现状与优化——基于国外经验的探讨  

Current Situation and Optimization for China’s Offsite Drug Inspection System:Discussion Based on International Experiences

作　　者：张婕颖 赵枫 范瑞雪 张苗苗 冉大强 茅宁莹[1] ZHANG Jie-ying;ZHAO Feng;FAN Rui-xue;ZHANG Miao-miao;RAN Da-qiang;MAO Ning-ying(School of International Pharmaceutical Business,China Pharmaceutical University;Shandong Center for Food and Drug Evaluation&Inspection)

机构地区：[1]中国药科大学国际医药商学院 [2]山东省食品药品审评查验中心

出　　处：《中国食品药品监管》2024年第9期150-163,共14页China Food & Drug Administration Magazine

基　　金：2023年中国药品监督管理研究会课题(2023-Y-Y-019);江苏省科学技术厅软科学研究项目(BR2022068);江苏省社科基金一般项目(22JZB002);江苏省高校哲学社会科学研究项目(2021SJA0075)。

摘　　要：本文通过分析我国药品非现场检查制度概况,采用词频、词云分析国内外药品非现场检查制度内容,总结国外药品非现场检查制度经验,并提出关于推进我国药品非现场检查制度规范化的思考,包括明确药品非现场检查工具在药品检查工作中的定位,加快出台药品非现场检查制度规范文件,明确非现场检查的适用场景及工作程序,更好地保障药品非现场检查工作质量。This paper analyzes the current situation of China's off-site inspection system and employs word frequency and word cloud analysis to examine the content of domestic and foreign off-site drug inspection systems.By summarizing the experiences of these international systems,the paper puts forward suggestions to promote the standardization of China's off-site inspection system,including clarifying the role of off-site inspection tools in drug inspection,accelerating the issuance of standardized documents for the off-site inspection system,defining applicable scenarios and procedures for off-site inspections,and ensuring the quality of off-site drug inspections.

关 键 词：非现场检查 远程检查 药品 制度 国外经验 

分 类 号：R95[医药卫生—药学]