【作者】 陈云；

【导师】 田侃；

【作者基本信息】 南京中医药大学 ， 社会医学与卫生事业管理， 2012， 硕士

【摘要】 近年来,随着社会主义市场经济的快速发展和科学技术水平的不断提高,我国医药行业也取得了突飞猛进的发展,满足了公众日益增长的用药需求。但与此同时,也带来了药品质量问题纠纷和药品不良事件的出现,更为严重的是药害事件的频繁发生。由于我国《药品管理法》主要集中在对假药、劣药的规定和管理方面,使得一些符合国家药品标准但仍然对公众健康造成威胁的药品无法律约束,对消费者健康造成极大的损害。我国虽然已制定《药品召回管理办法》,但召回对象界定不清晰,召回程序不科学,法律责任中处罚力度过轻等问题一一凸显,使得药品召回实施中存在较多问题。因此,本文基于上述现状,旨在建立适合我国的药品召回制度。本文首先试图界定本研究中召回“药品”的概念,阐述药品召回制度的发展及理论基础,然后分析我国药品召回制度和存在的问题,以及介绍美国药品召回制度,再通过比较中美药品召回制度,得出美国药品召回制度对我国的启示,最后提出完善我国药品召回制度的立法和政策建议。本文主要包括以下内容：一是界定清楚我国药品召回的对象；二是深入分析了我国药品召回制度和存在的问题；三是系统介绍了美国药品召回制度现状；四是进行中美药品召回制度相关内容比较,得出美国药品召回制度对我国的启示；五是提出了完善我国药品召回制度的思路和建议。本文的创新点在于,通过对FDA网站和SFDA网站实时公示信息数量的情况进行总结和分析,从中美两国药品召回程序和社会规制主体等方面的差异进行研究,并结合我国药品召回制度现状,提出了我国药品召回制度的立法模式,药品召回社会规制主体机构设置设想,以及召回程序中各方责任,具有一定的理论和实践价值。更多还原

【Abstract】 Nowadays, with the rapid development of socialist market economy and the improvement of science and technology, China’s medical industry has also made rapid development, to meet the growing drug needs of public. But at the same time, it also leads to drug quality problems and adverse drug events. The concerning of "Drug Administration Law" is only the guiding of fake or substandard pharmaceuticals. It makes some qualified drug with hidden danger without any legal restriction. Though "Drug Recall Administration" was announced, there are also some problems. For example obscure recalled objects, unreasonable recalling procedure and lightly penalty. The above problems make drug recall hard to be implemented. Based on these situations, our government should establish a suitable drug recall system.Firstly, this paper tries to specify the concept of "drug" which should be recalled, and expounds the development of drug recall system. Secondly, it analyzes the situation of China’s drug recall system. Thirdly, it introduces the drug recall system in America. Then, it compares the drug recall system of China&America. Lastly, it gives some advice about how to improve China’s drug recall system.The content of this article mainly focus on:①introducing objects of recall②analyzing the situation and implement obstacles of China’s drug recall system in depth③introducing the drug recall system of USA④comparing the relevant content of drug recall system between China&USA⑤coming up with some thinking and suggestions of China’s drug recall system.Compared with some relevant reference, this article has some innovation. By comparing&analyzing information form FDA and SFDA website, it discussed the difference of procedure and social regulation subject about drug recall between China and USA. Combined with the status and problems of drug recall in China, this paper proposed legislative models for drug recall, and imagines about how to construct main social regulation institution and responsibilities of relevant sides. It makes sense in theory and practice.更多还原