麻醉药品和精神药品监管主体法律问题研究

发布时间：2018-01-23 20:10

  本文关键词： 麻醉药品 精神药品 监管主体 模式　出处：《天津师范大学》2014年硕士论文　论文类型：学位论文

【摘要】：麻醉药品和精神药品是否安全,直接关系到广大人民群众的生命健康乃至社会的公共安全。随着我国医药卫生事业的发展,麻醉药品和精神药品监管已经成为行政法学界学者们共同关注的问题。文章意在对我国麻醉药品和精神药品行政监管主体的法律问题进行实践探索和研究,逐步完善我国麻醉药品和精神药品监管主体模式。 文章分为引言、正文和总结三部分。引言部分通过介绍发生在湖南湘潭的麻醉药品和精神药品流失事件,提出我国麻醉药品和精神药品监管主体方面存在的法律问题。正文部分从四个方面对我国麻醉药品和精神药品监管主体的法律问题展开论述。首先,文章第一部分对麻醉药品和精神药品监管的基本理论和法制基础分析。对麻醉药品、精神药品、药品监管、监管主体的基本概念进行了阐述。然后从法律角度和药事管理学角度分析了麻醉药品和精神药品监管的必要性。在此基础上,总结分析了我国麻醉药品和精神药品监管的法律法规基础。第二部分首先,阐述了美国麻醉药品和精神药品监管主体模式；其次,介绍了我国麻醉药品和精神药品监管主体的沿革及我国麻醉药品和精神药品监管主体的模式。对比分析了美国和我国在麻醉药品和精神药品监管主体模式上的异同。第三部分从CFDA的设置和法律定位、药品监管部门的人员构成、麻醉药品和精神药品监管主体模式以及医药行业协会的发展状况等角度分析。总结了我国麻醉药品和精神药品监管主体设置方面存在的问题。第四部分为我国麻醉药品和精神药品监管主体模式的完善。首先分析我国麻醉药品和精神药品监管主体设置存在问题的原因；其次,从法律角度提出完善措施。主要包括：健全我国麻醉药品和精神药品监管的法律法规体系、实现药品技术监管与行政监管相统一,确保监管主体独立性、加快中介组织立法,促进医药行业协会发展等方面提出了完善措施。文章最后得出结论,提出我国麻醉药品和精神药品监管主体模式应当逐步摆脱“一体,多部门”的混合监管模式,形成独立、统一、高效和公正的“独立监管”的主体模式。
[Abstract]:The safety of narcotic drugs and psychotropic drugs is directly related to the life and health of the broad masses of the people as well as the public safety of society. The regulation of narcotic drugs and psychotropic drugs has become a common concern of scholars in the field of administrative law. The purpose of this article is to explore and study the legal issues of the subject of administrative supervision of narcotic drugs and psychotropic drugs in China. Gradually improve the main mode of supervision of narcotic drugs and psychotropic drugs in China. The article is divided into three parts: introduction, text and summary. The introduction introduces the loss of narcotic drugs and psychotropic drugs in Xiangtan, Hunan province. The main body of the paper discusses the legal problems of the subject of narcotics and psychotropic drugs supervision in China from four aspects. First of all. The first part of the article analyzes the basic theory and legal basis of the supervision of narcotic drugs and psychotropic drugs, as well as the supervision of narcotic drugs, psychotropic drugs and drugs. The basic concept of the subject of supervision is expounded. Then the necessity of supervision of narcotic drugs and psychotropic drugs is analyzed from the point of view of law and drug management. This paper summarizes and analyzes the legal and regulatory basis of the supervision of narcotic drugs and psychotropic drugs in China. The second part first expounds the main model of the supervision of narcotic drugs and psychotropic drugs in the United States. Second. This paper introduces the evolution of the subject of narcotics and psychotropic drugs supervision in China and the mode of the main body of the supervision of narcotic drugs and psychotropic drugs in China. The differences between the main body modes of the supervision of narcotic drugs and psychotropic drugs in the United States and China are compared and analyzed. The third part from the CFDA settings and legal positioning. The composition of the drug regulatory department. This paper analyzes the main model of the supervision of narcotic drugs and psychotropic drugs and the development of pharmaceutical trade association, summarizes the problems existing in the subject setting of the supervision of narcotic drugs and psychotropic drugs in China. 4th part is the main body of the supervision of narcotic drugs and psychotropic drugs in China. The perfection of the subject mode of the supervision of intoxicated drugs and psychotropic drugs. Firstly, the reasons for the problems in the subject setting of the supervision of narcotic drugs and psychotropic drugs in China are analyzed. Secondly, from the legal point of view to improve the measures, including: improve our country's narcotic drugs and psychotropic drugs regulatory system of laws and regulations, to achieve the unity of drug technical supervision and administrative supervision, to ensure the independence of the main body of supervision. Finally, the paper draws a conclusion that the main mode of supervision of narcotic drugs and psychotropic drugs in our country should gradually get rid of "integration". The multi-department mixed supervision mode forms the independent, unified, efficient and impartial main body mode of "independent supervision".
【学位授予单位】：天津师范大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
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本文编号：1458136