首页|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

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

扫码查看
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.
Current Situation and Optimization for China's Off-site Drug Inspection System:Discussion Based on International Experiences
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.

off-site inspectionremote inspectiondrugssysteminternational experiences

张婕颖、赵枫、范瑞雪、张苗苗、冉大强、茅宁莹

展开 >

中国药科大学国际医药商学院

山东省食品药品审评查验中心

非现场检查 远程检查 药品 制度 国外经验

2023年中国药品监督管理研究会课题江苏省科学技术厅软科学研究项目江苏省社科基金一般项目江苏省高校哲学社会科学研究项目

2023-Y-Y-019BR202206822JZB0022021SJA0075

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
年,卷(期):2024.(9)
  • 6