药品质量监管研究1.docVIP

学位论文原创性声明 本人郑重声明，所呈交的学位论文，是本人在导师的指导下，独立进行研究工作所取得的成果。除文中已经注明引用的内容外，本学位论文不包括任何其他个人或集体已经发表或撰写过的成果 药品质量监管研究 中文摘要 近几年，我国质量安全事件频发，这与我国现行的品质量监督制度存在很大关系。，通过调查，来真实情况，并且通过的真实性及深度，。 相关概念涵义、特征、性质质量监的法律依据结论与建议 ABSTRACT In recent years, Chinas drug safety events, and Chinas current drug quality supervision system imperfect existence very big relations. Chinese drug supervision and administration system also has some problems, in order to fundamentally solve these problems need the drugs production enterprise and drug regulatory departments between the two together, pharmaceutical production enterprises according to their own under foot, the drugs production enterprise of each link on the strict quality control, to be honest and trustworthy; drug monitoring departments in the exercise of regulatory powers to accomplish lawfully administration, raise the level of business. From the system guarantee of drug information declaration and samples of authentic, scientific and standardized, and increased in the new drug research and registered in fraud crackdown, from the fundamental guarantee of the safety of medicines. In this paper a new information supervision and management experience, through investigation and analysis, to reveal the real situation of the domestic pharmaceutical quality management, and through various events in the authenticity of the description and analysis in depth, in order to further improve and guard against all kinds of adverse drug events and the development of drug management policy to provide a basis. The first chapter: introduction. The main account of the background and significance of this research, literature review and research content and language structure. And summarized the related literatures, proposes the theoretical basis and innovation. The second chapter: drugs and drug quality supervision related concepts. Introduces the meaning, characteristics, properties of drugs, and to our country drug quality supervision system of legal basis to do f