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对药用辅料与药品关联审评审批申报资料要求的解读与思考
对药用辅料与药品关联审评审批申报资料要求的解读与思考
任连杰1,马玉楠1,蒋 煜1,张凌超2

1 国家食品药品监督管理总局药品审评中心,北京 100038; 2 国家食品药品监督管理总局药品化妆品注册管理司,北京 100053
Interpretation and thinking of contents of the application dossier for evaluation  and approval of pharmaceutical excipients associated with drug products
(1 Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China;  2 Department of Drug and Cosmetics Registration, China Food and Drug Administration, Beijing 100053, China)

摘要参考文献相关文章

起始页:2128

摘要:[摘要] 通过对国内外药用辅料注册申报资料要求的梳理分析,对国家食品药品监督管理总局发布的药用辅料与药品关联审评审批申报资料要求(总局通告2016年155号附件2)进行详细解读,并对相关管理模式、尚需解决的问题以及未来的发展要求提出思考。

关键词:[关键词] 药用辅料;关联审评;申报资料

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基金项目:

作者简介:

Abstract:[Abstract] Based on summaries and analyses of the contents of application documents of pharmaceutical excipients both in China and some developed countries, the contents of the application dossiers for evaluation and approval of pharmaceutical excipients associated with drug products were interpreted in depth. The administration modes, issues to be solved and future development of industries were also discussed.

Key words:[Key words] pharmaceutical excipients;associated evaluation;application dossier

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