| 我国药品注册管理法规体系的形成及现状思考 |
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| 引用本文： | 张晓东,李连达. 我国药品注册管理法规体系的形成及现状思考[J]. 中国新药与临床杂志, 2010, 0(2) |
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| 作者姓名： | 张晓东 李连达 |
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| 作者单位： | 中国中医科学院医学实验中心;国家食品药品监督管理局药品审评中心; |
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| 摘 要： | 随着我国药品监管法律法规体系的逐步形成,药品注册管理的有关法规也经历了不断的补充和完善,构成了独立的药品注册管理法规体系。本文回顾了我国药品注册管理法规体系的形成和发展过程,对我国药品注册管理法规体系的现状以及当前面临的一些问题进行了分析和探讨。
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| 关 键 词： | 立法,药物 临床试用新药申请 组织和管理 药品注册 |
Development of law and regulation system of drug registration in China and views on its current status |
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| ZHANG Xiao-dong,,LI Lian-da. Development of law and regulation system of drug registration in China and views on its current status[J]. Chinese Journal of New Drugs and Clinical Remedies, 2010, 0(2) |
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| Authors: | ZHANG Xiao-dong LI Lian-da |
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| Affiliation: | ZHANG Xiao-dong1,2,LI Lian-da1(1.Experimental Research Center,China Academy of Chinese Medical Sciences,BEIJING 100700,China,2.Center for Drug Evaluation,State Food , Drug Administration,BEIJING 100038,China) |
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| Abstract: | With the development of law and regulation system of drug administration in our country,the regulations on drug registration have been ameliorated and turned into an independent law and regulation system of drug registration.This paper reviewed the course of formation and development,and analyzed the current status and some problems it is confronted with. |
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| Keywords: | legislation drug investigational new drug application organization and administration drug registration |
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