文档介绍：药品召回法律制度研究重庆大学专业硕士学位论文学生姓名:洪定鹤指导教师:陈晴副教授专业学位:法律硕士(法学) 重庆大学法学院二○一一年六月 The Drug RecallLegal System Research A Thesis Submitted to Chongqing University in Partial Fulfillment of the Requirement for the Degree of Master of Profession By Hong Dinghe Supervised by Associate Professor Chen Qing Profession: Juris Master(Law) College of law of Chongqing University, Chongqing, China May, 2011 重庆大学硕士学位论文中文摘要 I 摘要药品与公众的身体健康和生命安全息息相关,进入市场后的药品存在缺陷如出现严重的不良反应将导致严重的后果并给消费者带来巨大的损害。当前世界上许多国家为了保障患者的利益,都已经建立了药品召回法律制度并发挥了很好效果。近年来,我国相继发生了不少药品不良反应的事件,在引起关注的同时国家也针对药品召回颁布了药品召回管理办法,这标志着药品召回法律制度在我国的正式建立。药品召回法律制度在我国度仅仅处于起步阶段,从制度的出台到最后的实施和完善,都需要理论研究和实践的探索。国外的药品召回制度在规范程序和可操作性上,都值得我国药品召回制度在完善和推行时借鉴。本文从药品召回的基本理论开始论述,对药品召回及药品召回的法律制度进行理论上的考察,并对药品召回制度的建立和发展沿革进行描述,旨在对药品召回的有较初步的认识。同时通过与相关制度,如一般产品召回、伪劣产品规则及产品三包制度的比较分析中充实药品召回的理论研究层次。在理论探讨的同时, 厘清药品召回的基本架构也是药品召回制度理论的重要部分,在本文的第一部分对包括药品召回的主体、对象、方式、程度和责任在内的基本架构进行了分条的概述,最后从规范和保障角度对药品召回制度功能进行实践层次的考察。在理论研究的同时,借鉴国外的药品召回相关经验,特别是药品召回的具体制度规定对药品召回制度在我国的推行具有重要意义。本文在对域外药品召回制度的考察上,通过比较我国现行药品召回制度推行存在的问题,借鉴国外解决药品召回制度存在问题的措施,力图解决我国药品召回在实施中存在诸如召回案例不高,召回信息不畅等方面的问题。最后提出现阶段我国在完善推行药品召回制度的法律构想,希望通过对这些问题的研究,对我国药品召回的实施在理论支持和实践操作中提供指导。关键词:产品召回制度,药品召回制度,责任重庆大学硕士学位论文英文摘要 II ABSTRACT Drugs closely related to public health and safety. Drugs enter the market after serious defects, such as adverse reactions will lead to serious consequences and enormous damage to consumers. At present, many countries in order to protect the interests of patients, have established a drug recall and the legal system has played a very good recent years, China has undergone a lot of the events of adverse drug reactions, while in countries of concern for Drug Recall issued the "Administration of drug recall", which indicates that the legal system drug recall formally established in China. Drug Recall degree of legal system in China is only in its infancy, from the introduction of the system to the final implementation and i