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.
作者
张婕颖
赵枫
范瑞雪
张苗苗
冉大强
茅宁莹
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)
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)。
关键词
非现场检查
远程检查
药品
制度
国外经验
off-site inspection
remote inspection
drugs
system
international experiences
