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论我国药品经营的行政监管

发布时间:2018-08-30 13:59
【摘要】:2016年,山东菏泽发生的“毒疫苗”事件骇人听闻,网络大V、微博、微信等多种媒介对此消息的迅速传播,一时间造成了不小的社会恐慌,与此同时,人民用药安全问题再一次被提上议事日程。对于药品这种切身关系人身体健康和生命安全的特殊商品的经营,出现此种情形,国家负有不可推卸的监管责任。在追责后,痛定思痛,我们仍需要分析这种情况产生的原因,找到我国现有监管模式存在的缺陷,并通过学习借鉴,弥补这些监管上的漏洞,使人民能够放心用药。笔者总共将本文分为四个大部分:本文第一章对我国药品经营行政监管做了简单介绍,并对山东“毒疫苗”事件进行了分析,深入剖析我国药品经营行政监管的必要性,紧接着对我国药品经营行政监管的发展脉络进行了梳理,对我国药品经营行政监管从纵向上进行了把握;第二章简明介绍了我国药品经营行政监管的现状,并从监管主体、法律依据、信息公开等多个方面找出了既有模式存在的缺陷;第三章对先进的药品经营监管模式:美国、日本等国家的监管模式进行了介绍,总结他们的特点及优势所在,并因此得到几点我国药监机关今后如何发展的启示;第四章在前文分析总结的基础上,依据我国现有的药品经营监管模式,分别从监管体制的转变、监管力度的增强、法律体系的构建以及进一步信息公开等方面提出几点完善建议,虽然不算太成熟,但希望能对我国药品经营监管模式的发展进步有点滴贡献。
[Abstract]:In 2016, the "virulent vaccine" incident in Heze, Shandong Province, was appalling. The rapid spread of the news by various media, such as Internet giant V, Weibo and WeChat, caused a great deal of social panic at the same time. Once again, the issue of the safety of drug use by the people has been put on the agenda. The management of medicine, a special commodity which is closely related to the health and safety of human beings, is under the responsibility of supervision and control by the state. We still need to analyze the causes of this situation, find out the defects of our country's existing regulatory model, and make up for these loopholes in supervision through learning and learning, so that the people can rest assured of using drugs. The author divides this article into four parts altogether: in the first chapter of this paper, the author makes a brief introduction to the administrative supervision of drug management in China, analyzes the incident of "toxic vaccine" in Shandong Province, and deeply analyzes the necessity of administrative supervision of drug management in our country. The second chapter briefly introduces the current situation of China's drug management administrative supervision, and introduces the main body of supervision from the point of view of the main body of the supervision, the second chapter gives a brief introduction to the current situation of China's drug management administrative supervision. Legal basis, information disclosure and other aspects to find out the defects of the existing model. Chapter three introduces the advanced drug management regulatory model: the United States, Japan and other countries, summed up their characteristics and advantages. The fourth chapter is based on the previous analysis and summary, according to the existing mode of drug management supervision in China, respectively from the transformation of the regulatory system, the strengthening of supervision. Some suggestions on the construction of legal system and the further disclosure of information are put forward. Although they are not too mature, they hope to make some contributions to the development and progress of the mode of drug management and supervision in China.
【学位授予单位】:兰州大学
【学位级别】:硕士
【学位授予年份】:2017
【分类号】:D922.16

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