| 浅析《药品注册现场核查管理规定》 |
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| 引用本文： | 高鹏. 浅析《药品注册现场核查管理规定》[J]. 中国药事, 2008, 22(11) |
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| 作者姓名： | 高鹏 |
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| 作者单位： | 天津市药品审评中心,天津,300070 |
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| 摘 要： | 分析了《药品注册现场核查管理规定》的出台对药品注册现场核查工作可能产生的影响,对《规定》中的一些内容进行了探讨。
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| 关 键 词： | 药品 注册 现场核查 |
Preliminary analysis of Requirements for On-site Verification for Drug Registration |
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| Gao Peng. Preliminary analysis of Requirements for On-site Verification for Drug Registration[J]. Chinese Pharmaceutical Affairs, 2008, 22(11) |
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| Authors: | Gao Peng |
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| Affiliation: | Tianjin Drug Evaluation Center;Tianjin 300070 |
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| Abstract: | The new SFDA regulation:Requirements for On-site Verification for Drug Registration was analyzed and the impact to present work of on-site verification was concluded. |
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| Keywords: | drug registration on-site verification |
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