中国食品药品监管Issue(1)：74-85,12.DOI:10.3969/j.issn.1673-5390.2025.01.007
基于政策文本的分析探讨我国药品检查体系的变迁
Exploring the Changes in China's Drug Inspection System Based on Policy Text Analysis
摘要
Abstract
Objective:This study aims to examine the evolution of China's drug inspection system and provide recommendations for its further optimization.Methods:Using the text analysis tool"Micro-Word Cloud",67 drug inspection-related policies from 1984 to 2024 were quantitatively analyzed.The historical trajectory of the drug inspection system was explored from three dimensions:system,institution,and personnel.Results:The evolution of the drug inspection system can be categorized into three phases:the initial exploration period(1984～2002),the rapid development period(2003～2015),and the quality improvement and efficiency enhancement period(2016～2024).From a system perspective,drug inspection regulations have been gradually improved,incorporating digital and international innovations,with the focus shifting from result-based supervision to whole-process supervision.Institutionally,the functions and management methods have improved over time,with growing emphasis on synergy and cooperation among drug inspection institutions.In terms of personnel,the importance of building a professional and specialized team of inspectors has gained increasing attention,with relevant policies enacted to provide clear legal status and support.Conclusion:To further improve drug inspection efficiency and better safeguard public medication safety,recommendations include enhancing the management of drug inspector team,accelerating the development of intelligent drug inspection systems,promoting whole-process risk management in drug inspection work,and advancing the internationalization of the drug inspection process.关键词
药品检查体系/政策文本/制度/机构/人员Key words
drug inspection system/policy text/system/institution/personnel分类
医药卫生引用本文复制引用
范瑞雪,张婕颖,李军,严迪磊,茅宁莹..基于政策文本的分析探讨我国药品检查体系的变迁[J].中国食品药品监管,2025,(1):74-85,12.基金项目
2024年度江苏高校哲学社会科学研究重大项目(2024SJZD128) （2024SJZD128）
2024年度江苏省社科应用研究精品工程重点资助项目(24SYA-029) （24SYA-029）
2024年度江苏省社科应用研究精品工程一般资助项目(24SYB-015) （24SYB-015）
