本文通过对美国医药产品召回制度和相关典型案例的介绍,初步解析了美国FDA在实施药品、医疗器械监督召回中,值得我国借鉴的一些成功经验。同时,报告简要阐述和分析了上海市1家大型药品批发企业和1家药品生产企业的近年召回情况,提出了我国建立和完善地方缺陷药品、医疗器械召回制度的重要意义和基本构想。
<<This article is intended to,through introducing the medical product recall system and related typical cases in USA,analyze the successful experience of FDA in implementation recall of drugs and medical devices,which can be used for our reference;and briefly introduce and analyze the recalls of one large drug wholesale company and one drug manufacturer in Shanghai in recent years,and propose the significance and the basic conception for establishing the recall system of defective drugs and medical devices.
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