中国与欧美CGMP比较研究

发布时间：2018-06-03 00:37

本文选题：药事管理 + GMP　；参考：《上海交通大学》2014年硕士论文

【摘要】：在生产和市场全球化的趋势下,制药行业的竞争愈演愈烈。与欧美制药行业相比,国内的药事管理还处于初级阶段,为了能够在未来的竞争中立于不败之地,我国制药企业必须加强药事管理方面的建设,最主要的是加强现行药品生产质量管理规范CGMP(Current Good Manufacturing Practice)方面的控制,中国药监部门不断地加大对药品生产的监管力度,以保证人民用药安全。中国医药企业虽然已经走过了GMP的初级阶段,但与世界发达国家相比还有差距,认真执行并严格贯彻CGMP还有相当长的路要走。本文通过对药事管理及CGMP相关法律法规及文献的深入研究,综合分析了我国药事管理及GMP的发展进程,并与美国和欧盟等国的CGMP进行比较,以期借鉴发达国家的经验,促进我国CGMP的完善。本文第一章概括介绍了药事管理和CGMP的概念。GMP是药事管理活动在药品生产方面的管理规范,是保证人们用药安全的必须准则,所以国内外制药企业必须通过CGMP认证生产的药品才能上市销售。第二章介绍中国及欧美GMP的发展历程。重点阐述了CGMP得以提出以及实行对制药企业的必要性。第三章重点介绍我国新版GMP实施的现状及与美国、欧盟的比较分析。给出具体的数据和示例,阐释了新版GMP与美国在动态监管及质量风险管理方面,与欧盟在细致性、深入性等方面的不同第四章对全文进行了总结,阐述了本文的主要论点及进一步改善的的地方。
[Abstract]:In the trend of globalization of production and market, the competition of pharmaceutical industry is becoming more and more intense. Compared with the European and American pharmaceutical industry, the domestic pharmaceutical management is still in the initial stage, in order to be able to be invincible in the future competition, our pharmaceutical enterprises must strengthen the construction of pharmaceutical management. The most important thing is to strengthen the control of the current drug production quality management standard CGMP(Current Good Manufacturing Practice). The Chinese drug supervision department continuously strengthens the supervision of the drug production in order to ensure the safety of drug use by the people. Although Chinese pharmaceutical enterprises have passed through the initial stage of GMP, there is still a gap compared with the developed countries in the world, and there is still a long way to go to implement and strictly implement CGMP. Based on the in-depth study of pharmaceutical management and CGMP laws and regulations, this paper comprehensively analyzes the development process of drug management and GMP in China, and compares them with the CGMP of the United States and the European Union in order to learn from the experiences of developed countries, such as the United States of America and the European Union, in order to draw lessons from the experience of the developed countries. To promote the perfection of CGMP in China. In the first chapter of this paper, the concept of drug management and CGMP is introduced, which is the standard of drug management in drug production, and is the necessary criterion to ensure the safety of drug use. So domestic and foreign pharmaceutical enterprises must pass the CGMP certification production of drugs can be sold on the market. The second chapter introduces the development of GMP in China and Europe. The necessity of putting forward and implementing CGMP to pharmaceutical enterprises is emphasized. The third chapter focuses on the implementation of China's new GMP status and comparative analysis with the United States and the European Union. This paper gives specific data and examples, explains the new version of GMP and the United States in terms of dynamic regulation and quality risk management, and the European Union in detail, depth and other aspects of the different chapter IV summarized the full text. The main points of this paper and further improvement are expounded.
【学位授予单位】：上海交通大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：F426.72

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