| 美国药品安全监管机制改革研究 |
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| 引用本文： | 郗昊,姚蕾.美国药品安全监管机制改革研究[J].中国药事,2018,32(8):1043-1050. |
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| 作者姓名： | 郗昊 姚蕾 |
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| 作者单位： | 中国食品药品检定研究院, 北京 102629,中国食品药品检定研究院, 北京 102629 |
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| 摘 要： | 目的：研究美国药品安全监管改革机制，为完善中国药品安全监管体系提供参考。方法：汇总分析2007-2018年美国药品安全监管改革关键措施。结果与结论：通过改革，美国建立了基于风险评估的药品全生命周期管理体系和专业的监管队伍，有效鼓励创新并保证药品安全性。
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| 关 键 词： | FDA 药品安全监管改革 参考 |
| 收稿时间： | 2018/4/26 0:00:00 |
Research on the Reform of Drug Safety Regulatory System in USA |
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| Xi Hao and Yao Lei.Research on the Reform of Drug Safety Regulatory System in USA[J].Chinese Pharmaceutical Affairs,2018,32(8):1043-1050. |
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| Authors: | Xi Hao and Yao Lei |
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| Institution: | National Institutes for Food and Drug Control, Beijing 102629, China and National Institutes for Food and Drug Control, Beijing 102629, China |
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| Abstract: | Objective:To study the reform of drug safety regulatory system in USA and to provide references for improving drug safety regulatory system in China. Methods:Key measures for the reform of drug safety regulatory system in USA from 2007 to 2018 years were summarized and analyzed. Results and conclusion:A life cycle management system of drugs and a professional regulatory team have been established in USA based on risk assessment to effectively encourage innovation and ensure drug safety by means of reform. |
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| Keywords: | FDA drug safety regulatory system reform reference |
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