| 国内外药品GMP对比调研报告（三） |
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| 引用本文： | 国家食品药品监督管理局药品认证管理中心. 国内外药品GMP对比调研报告（三）[J]. 中国药事, 2008, 22(12) |
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| 作者姓名： | 国家食品药品监督管理局药品认证管理中心 |
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| 作者单位： | 国家食品药品监督管理局药品认证管理中心,北京,100061 |
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| 摘 要： | 在回顾了我国实施GMP的基本情况,分析了国际药品GMP的现状与特点的基础上,进一步研究对比我国与欧盟、WHO、美国GMP通则之间存在的具体差异,为实现我国药品GMP与国际先进水平接轨提供参考。
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| 关 键 词： | 药品 GMP通则 欧盟 美国 对比研究 |
Contrast Research Report of Domestic and Foreign Drug GMP (3) |
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| State Food and Drug Administration Center for Certification of Drug. Contrast Research Report of Domestic and Foreign Drug GMP (3)[J]. Chinese Pharmaceutical Affairs, 2008, 22(12) |
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| Authors: | State Food and Drug Administration Center for Certification of Drug |
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| Affiliation: | Beijing 100061 |
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| Abstract: | After reviewing the implementation of the basic situation of Chinese GMP,the current situation and characteristics of the international drug GMP were analyzed.In further study,the difference of GMP general rule was compared between China with the European Union,WHO and the United States.It provides reference standards to make level of Chinese drug GMP with the international advanced level. |
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| Keywords: | WHO |
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