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。
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.
作者
郗昊
姚蕾
Xi Hao;Yao Lei(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药事》
CAS
2018年第8期1043-1050,共8页
Chinese Pharmaceutical Affairs
关键词
FDA
药品安全监管改革
参考
FDA
drug safety regulatory system reform
reference
