| 新《药品注册管理办法》出台后的药品注册申报工作 |
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| 引用本文： | 吴浩,张清.新《药品注册管理办法》出台后的药品注册申报工作[J].中国新药与临床杂志,2008,27(11). |
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| 作者姓名： | 吴浩 张清 |
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| 作者单位： | 上海市食品药品监督管理局认证审评中心,上海,200020 |
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| 摘 要： | 新《药品注册管理办法》及其配套的《药品注册现场核查管理规定》的出台,对于药品注册申报提出了更高的要求。本文主要说明修订后的《药品注册管理办法》主要变化的内容和要求,并就今后药品研发和注册申报中需要注意的几个问题进行探讨。
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| 关 键 词： | 药品和麻醉品检定 组织和管理 临床试用新药申请 药品注册管理办法 药品注册申报 药品研发 |
Discussion on drug registration application after promulgation of new provisions for drug registration |
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| WU Hao,ZHANG Qing.Discussion on drug registration application after promulgation of new provisions for drug registration[J].Chinese Journal of New Drugs and Clinical Remedies,2008,27(11). |
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| Authors: | WU Hao ZHANG Qing |
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| Institution: | WU Hao ZHANG Qing (Center for Drug Certification , Evaluation,Shanghai Food , Drug Administration,SHANGHAI 200020,China) |
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| Abstract: | The requirements were much higher for drug registration application after the newProvisions for Drug Registrationand its complement regulatory documentRequirements for On-site Verification for Drug Registrationhave been issued.This article is mainly about the change,requirement,and contents of the revisedProvisions for Drug Registration,and provided evaluation interpreted and diseussion of some problems for the drug research and registration application in the foreseen future. |
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| Keywords: | drug and narcotic control organization and administration investigational new application provisions for drug registration drug registration application drug research and development |
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