我国疫苗安全监管法律研究

发布时间：2018-12-17 06:39

【摘要】：当今社会,医药行业的发展十分迅猛。疫苗产业发展同样令人瞩目。然而,接连的疫苗安全事故相继曝光,疫苗安全成为了热议的焦点,这严重扰乱了我国疫苗市场的秩序,代表疫苗在研发、生产及流通环节存在着严重问题,同时更加反映出我国疫苗安全监管领域存在着的漏洞。本文共分六章。第一章绪论。主要阐述我国疫苗安全监管的研究现状以及本文的研究目的和意义,进而提出本文研究方法。第二章疫苗安全监管概述。首先对相关概念予以阐述。其次,分析我国疫苗监管立法体系。最后,强调加强疫苗监管必要性。第三章国外疫苗安全监管法律体系,通过对美国、德国、日本这三个国家疫苗安全监管体系及相关法律规定的阐述,进而引出我国疫苗安全监管体系中存在的问题,借鉴国外的先进经验,最终提出国外疫苗安全监管法律体系给我国带来的启示。第四章疫苗监管存在问题法律分析。围绕案例,主要从三个方面阐述我国疫苗监管存在问题。即从监管范围、程序以及方式三个角度指出我国疫苗监管中存在的漏洞。第五章针对相关问题的法律建议。首先,制定统一的《疫苗安全法》。其次,完善我国疫苗安全监管方式。本文主要从行政立法、行政检查以及行政处罚三个方面加以论述。在此基础上,提出相关的完善建议。最后,完善疫苗监管程序。主要从疫苗信息公开以及接种疫苗异常反应处理两个方面加以完善。第六章结语。
[Abstract]:Nowadays, the development of pharmaceutical industry is very rapid. The development of the vaccine industry is equally impressive. However, successive vaccine safety accidents have been exposed one after another, and vaccine safety has become the focus of heated discussion. This has seriously disturbed the order of the vaccine market in our country and represents serious problems in the research and development, production and circulation of vaccines. At the same time, it also reflects the loopholes in the field of vaccine safety supervision in China. This paper is divided into six chapters. The first chapter is introduction. The present situation of vaccine safety supervision in China and the purpose and significance of this paper are described, and the research methods of this paper are put forward. Chapter II Overview of vaccine safety supervision. First of all, the related concepts are expounded. Secondly, the legislation system of vaccine supervision in China is analyzed. Finally, the necessity of strengthening vaccine supervision is emphasized. The third chapter of the foreign vaccine safety regulatory legal system, through the United States, Germany, Japan, these three countries vaccine safety regulatory system and related laws and regulations, and then lead to China's vaccine safety regulatory system problems, Draw lessons from the advanced experience of foreign countries, and finally put forward the enlightenment of foreign vaccine safety regulatory legal system to our country. Chapter IV legal analysis of the problems in vaccine supervision. Around the case, mainly from three aspects of China's vaccine regulatory problems. That is to point out the loopholes in vaccine regulation in China from three aspects: supervision scope, procedure and mode. The fifth chapter aims at the related question legal suggestion. First of all, formulate a unified Vaccine Safety Act. Secondly, consummate our country vaccine safety supervision way. This article mainly discusses from three aspects of administrative legislation, administrative inspection and administrative punishment. On this basis, put forward the relevant improvement suggestions. Finally, improve the vaccine regulatory procedures. Mainly from the vaccine information disclosure and vaccination abnormal reaction processing two aspects to be improved. Chapter VI conclusion.
【学位授予单位】：延边大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D922.16;R95

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