| 我国新药审批办法及实施现状 |
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| 引用本文： | 张志军. 我国新药审批办法及实施现状[J]. 中国药房, 1994, 0(5) |
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| 作者姓名： | 张志军 |
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| 作者单位： | 卫生部药政管理局 |
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| 摘 要： | 本文着重对我国新药审批依据的主要法规、新药管理范围及分类、新药的临床前研究和临床试验的一般要求、新药的申报及审批等及其实施现状进行了介绍。
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| 关 键 词： | 新药，审批办法，实施现状 |
Procedure for Examination and Approval of New Drugs and Present Situation of Implementation in China |
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| Zhang Zhijun. Procedure for Examination and Approval of New Drugs and Present Situation of Implementation in China[J]. China Pharmacy, 1994, 0(5) |
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| Authors: | Zhang Zhijun |
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| Abstract: | This paper presents the examination and approval of new drugs in China. Emphasis is put on (1) Legal basis of the procedure,(2)range and clasification of new drugs,(3)requirements for preclinical study and clinical trial of new drugs,(4)declaration examination and approval of new drugs,(5)present situation of implementation. |
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| Keywords: | new drug procedure for examination and approval present situation of implementation |
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