中国药品一致性评价国际借鉴【摘要】我国在制药行业有一项重要的评测规则，那就是中国药品一致性评价。这项规定是在“十二五”期间，在我国专门针对药品质量所颁布的政策中的的一项规范。严格管理，提高药品上市质量，优化制药行业品类结构，扩大药品出口份额，提高我国药品的国际竞争力，对于我国医学、医药的可持续发展，发挥着重要影响。本文系统地阐述了中国药品一致性评价国际借鉴，分析了国内、国外药品一致性评价对我国药品行业发展重要指导意义及深远影响，并提出相应的建议。【关键词】原研药，仿制药，药品一致性评价注：本论文（设计）题目来源于教师的国家级（或省部级、厅级、市级、校级、企业）科研项目，项目编号为： 。International Reference for Chinese Drug Consistency Evaluation[Abstract]Drug consistency assessment is a drug quality requirement in the "Twelfth Five-Year Plan" for National Drug Safety. It is one of the important policies of China's pharmaceutical industry. Strict management, improving the quality of drug review and approval, optimizing the variety structure of the pharmaceutical industry, promoting drug exports, enhancing the international competitiveness of China's drugs, and promoting the sustainable development of China's medicine and pharmaceutical Is of great significance. This article systematically expounds the international reference of Chinese drug consistency evaluation, analyzes the important guiding significance and far-reaching impact of domestic and foreign drug consistency evaluation on the development of China's pharmaceutical industry, and puts forward corresponding suggestions.[Keywords] Original research drug, generic drug, drug consistency evaluation目 录TU1.药品一致性评价的含义UT...................................1TU2.原研药与仿制药UT.........................................2TU2.1.原研药与仿制药的含义UT...........................................2TU2.2.原研药与仿制药的区别UT...........................................2TU2.3.我国仿制药的历...
