药品垂直监管体制研究

发布时间：2018-05-08 22:24

本文选题：药品监管 + 垂直管理　；参考：《上海交通大学》2013年硕士论文

【摘要】：药品是用于预防、诊断和治疗人类疾病的物质。药品安全有效直接关系到国民健康和公众安全。药品安全保障需要建立在高效监管的基础上。而药品监管的管理体制是药品监管事业发展的核心问题。因此，要提高药品监管效能，必须先要完善药品监管的管理体制。近年来，我国药品安全领域事故不断，爆发了一系列震惊全国的药害事件，药品安全问题对政府信任带来了巨大的挑战。虽然政府高度重视药品监管工作，但是对药品监管的职能定位和改革目标依然不明确，药品监管的体制改革也在不断进行。本文通过文献研究法、比较分析法和案例分析法等研究方法，回顾了建国以来药品监管体制的历史沿革，着重分析了我国现行的药品监管体制中存在的问题，阐述垂直管理存在的优势和不足，借鉴不同国家先进的监管理念。从公共管理的角度分析指出，，现阶段的中国国情决定了药品监管实施垂直管理有其必然性和必要性：有利于克服地方保护主义；有利于强化区域间统一协调；有利于集中技术监督的力量支撑。建议集中统一药品监管职能，设置独立垂直、专业化的药品监管部门，加快推进药品监管体制改革。
[Abstract]:Drugs are substances used to prevent, diagnose and treat human diseases. Drug safety is directly related to national health and public safety. Drug safety and security needs to be based on efficient supervision. The management system of drug regulation is the core of the development of drug supervision. Therefore, in order to improve the effectiveness of drug regulation, we must first improve the management system of drug regulation. In recent years, there have been a series of accidents in the field of drug safety in China, which have shocked the whole country. The problem of drug safety has brought a great challenge to the government trust. Although the government attaches great importance to the work of drug regulation, the function orientation and reform goal of drug regulation are still unclear, and the system reform of drug regulation is also ongoing. Through the methods of literature research, comparative analysis and case analysis, this paper reviews the history of drug supervision system since the founding of the people's Republic of China, and emphatically analyzes the problems existing in the current drug supervision system in China. This paper expounds the advantages and disadvantages of vertical management, and draws lessons from the advanced supervision ideas of different countries. From the point of view of public administration, it is pointed out that the current situation of China determines the necessity and inevitability of the implementation of vertical management of drug supervision: to overcome local protectionism, to strengthen regional unity and coordination; It is conducive to centralized technical supervision of the strength of the support. It is suggested that the function of drug supervision should be centralized and unified, the independent, vertical and specialized drug supervision department should be set up, and the reform of drug supervision system should be accelerated.
【学位授予单位】：上海交通大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：R954

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