中国食品药品监管2024,Issue(9) :150-163.DOI:10.3969/j.issn.1673-5390.2024.09.016

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 Off-site Drug Inspection System:Discussion Based on International Experiences

张婕颖 赵枫 范瑞雪 张苗苗 冉大强 茅宁莹
中国食品药品监管2024,Issue(9) :150-163.DOI:10.3969/j.issn.1673-5390.2024.09.016

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 Off-site Drug Inspection System:Discussion Based on International Experiences

张婕颖 1赵枫 1范瑞雪 1张苗苗 1冉大强 2茅宁莹1
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作者信息

  • 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
  • 折叠

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.

Abstract

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

Key words

off-site inspection/remote inspection/drugs/system/international experiences

引用本文复制引用

基金项目

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)

出版年

2024
中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
参考文献量6
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