关于国外开展药品上市后再评价相关制度的分析  

On Systems of Post-marketing Drug Reevaluation in Foreign Countries

作　　者：向秋静[1] 叶桦[1] 

机构地区：[1]复旦大学药学院,上海201203

出　　处：《中国药事》2016年第4期406-410,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:为建立我国药品上市后再评价制度提供参考,保证药品上市后的安全、有效。方法:收集并介绍美国、日本及世界卫生组织药品上市后再评价的相关法律、制度。结果与结论:美国、日本及世界卫生组织均对药品上市后再评价制订了相关法律及制度,还有具体的实施规范和技术支撑计划,值得我们借鉴。Objective： To provide the references for policymaking on post-marketing drug reevaluation in China, and to improve the post-marketing rational use of drugs. Methods： The relevant laws and institutions about postmarketing drug reevaluation made by the U.S. Japan and the World Health Organization were collected and introduced. Results and Conclusion： Laws with the specific code of practice and technology were established to guarantee the post-marketing drug reevaluation in the U.S. Japan and WHO, which could provid the references to ensure the safety and rational use of drugs in our country.

关 键 词：药品再评价 美国 日本 药品安全 

分 类 号：R95[医药卫生—药学]