美国新药上市后定期汇总报告的研究

摘要

周期性药物不良事件报告和药品年度报告是美国新药上市后的美国食品药品监督管理局要求药企递交的两种主要的定期汇总报告。这两种报告为管理上市药品、评估药品风险利益提供了必要的信息。文章介绍了两种报告的汇报时限和内容，并将这两种报告与中国采用的定期安全性更新报告进行了比较，指出不同。最后阐述了定期汇总报告在未来的变化趋势，希望对国内该领域工作起到参考借鉴作用。%Periodic adverse drug experience report and annual report are the two major post-marketing aggregate reports required by U.S. Food and Drug Administration (FDA) once a new drug application is approved in the United States. The two post-marketing aggregate reports provide necessary safety and efifcacy information to FDA for beneift-risk evaluation. This article introduces the two major post-marketing periodic aggregate reports, which are compared with the Periodic Safety Update Report (PSUR) adopted in China so as to point out their differences. Finally, the future direction of the post-marketing aggregate reports is evolved. And hopefully the information contained in this article can be referred and used in the pharmaceutical industry of China.