摘要
本文以美国FDA按产品类别重组检查机构的计划为研究对象,剖析该计划的内容及特点,并结合FDA警告信等统计数据初步分析计划的实施效果。结果显示,计划推行后,警告信发放数量有所增加,同时从检查到警告信发放的时间间隔减少,表明FDA检查执法活动愈加严格、高效。建议中国应完善检查队伍分类管理,进一步划分基层检查队伍,并健全部门间沟通协调机制,以此完善中国的药品检查体系。
This article takes FDA reform of inspection agency by product types as the research object,analyzes its content and characteristics,and discusses the implementation effects with the statistical data based on the number of FDA warning letters is sued.The results of the analysis revealed that the number of warning letters issued increased while the interval between inspection and issuing warning letters decreased,which indicated that the FDA inspection and enforcement activities became more effective and effi cient.For further improvement of the drug administration in China,we need to improve the classification of product-based inspection force,and strengthen the interdepartmental coordination.
作者
柳婷婷
陈永法
LIU Ting-ting;CHEN Yong-fa(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China)
出处
《国际药学研究杂志》
CAS
北大核心
2020年第2期104-109,共6页
Journal of International Pharmaceutical Research
基金
2015年国家社会科学基金资助项目(15BZZ052)
中国药科大学“双一流”学科创新团队建设项目(CPU2018GY40)。
关键词
检查队伍专业化
基于产品的检查
项目整合计划
改革
inspection force specialization
product-based inspection
program alignment
reform
