刍议我国药品技术审评原则和程序的新变化  

New developments in the principle and procedure of technical evaluation on drugs in China

作　　者：李艳坤[1] 邢花[1] 陈宇[2] 张岩柏[3] 

机构地区：[1]沈阳药科大学,沈阳110016 [2]清华大学深圳研究生院,深圳518055 [3]武警沈阳指挥学院门诊部,沈阳110113

出　　处：《中国新药杂志》2012年第10期1073-1075,1139,共4页Chinese Journal of New Drugs

摘　　要：2011年初国家药品监督管理局审评中心进行了内部机构的重组,随后颁布了《药品技术审评原则和程序》及相关文件来指导药品审评中心的工作。本文通过初步分析机构改革和《药品技术审评原则和程序》及相关文件的新特点,研究其影响及意义,优点与不足。为CDE提出尚需完善的建议,希望对其发展有所帮助。In early 2011, Center for Drug Evaluation （CDE） of the State Food and Drug Administration conducted the internal reorganization, and issued the ＂Drug Technical Review of the Principles and Procedures＂ and related documents to guide the work of the CDE. This paper preliminarily analyzed the new features of institutional reform and of the ＂Drug Technical Review of the Principles and Procedures＂ and related documents, to evaluate its effects and significance, the advantages and disadvantages. This paper also put forward the suggestions for CDE perfected to promote its rapid development.

关 键 词：审评原则 审评程序 机构重组 

分 类 号：R95[医药卫生—药学]