| 中美药品GMP比较研究 |
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| 引用本文： | 刘禹. 中美药品GMP比较研究[J]. 医药工程设计, 2007, 28(6): 43-46 |
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| 作者姓名： | 刘禹 |
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| 摘 要： | 比较中美两国GMP立法的差异,即中美两国GMP在法律和文化上的不同。中国制药企业要达到美国FDAcGMP符合性,应加强建立程序和证据。
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| 关 键 词： | 法律差异 文化差异 程序 证据 |
| 文章编号： | 1008-455X（2007）06-0043-04 |
| 收稿时间： | 2007-09-05 |
| 修稿时间： | 2007-09-05 |
Comparison and Research of Drug GMP in China and USA |
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| Liu Yu. Comparison and Research of Drug GMP in China and USA[J]. Pharmaceutical Engineering Design, 2007, 28(6): 43-46 |
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| Authors: | Liu Yu |
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| Abstract: | In this article, the legal and cultural differences between Chinese GMP and US FDA cGMP were compared. To reach the requirements of US FDA cGMP, Chinese pharmaceutical enterprises should more strengthen the control on procedure and evidence. |
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| Keywords: | FDA cGMP |
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