| 美国药品审评制度改革对我国的启示 |
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| 引用本文： | 耿晓雅,邵蓉.美国药品审评制度改革对我国的启示[J].北方药学,2015(4):139-140. |
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| 作者姓名： | 耿晓雅 邵蓉 |
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| 作者单位： | 中国药科大学国际医药商学院 南京 211198 |
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| 摘 要： | 本文概述了我国药品审评现状，介绍了美国药品审评制度改革经验，探讨如何提升我国药品审评的质量和效率。研究认为，我国应完善审评法规体系，增加资源投入，规范审评程序、细化时限规定、制定审评模板，进行质量管理，构建制度评价体系。
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| 关 键 词： | 药品审评 美国 制度改革 |
The Illumination of Drug Review System Reform in American for China |
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| Geng Xiaoya
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Shao Rong.The Illumination of Drug Review System Reform in American for China[J].BEIFANG YAOXUE,2015(4):139-140. |
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| Authors: | Geng Xiaoya Shao Rong |
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| Institution: | Geng Xiaoya;Shao Rong;International Pharmaceutical Business School,China Pharmaceutical University; |
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| Abstract: | This paper explores how to improve the quality and efficiency of China's drug review by summarizing the current situation of drug review in china and introducing the experience of drug review reform in American. The study suggests that China should improve legal system, increase review resources, regulate review process, detail drug review timeline, develop review template, proceed quality management, and build regulatory evaluation system. |
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| Keywords: | Drug Review American Institutional Reform |
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