我国抗菌药物说明书临床内容的撰写要求

Requirements for clinical contents presentation of the package insert on antibacterial agents in China

目前,我国抗菌药物说明书在临床内容撰写方面存在的一些问题,影响了说明书对临床用药的指导性作用,因此,本文介绍了新修订的《抗菌药物临床试验技术指导原则》中有关说明书临床内容撰写的新要求,以期为该类药物说明书更科学合理的撰写提供参考。

Now, some issues about the presentation which influence the guidance role for clinical medication existed in the clinical contents of the package insert on antibacterial agents. So, this article introduce the new requirements about the this part of contents in the newly revised guidelines for clinical research of antibacterial agents in order to make the related presentation more scientific and more reasonable.