FDA《人用处方药和生物制品说明书的用量和用法部分指导原则》概述  

Review of the guidance for industry:dosage and administration section of labeling for human prescription drug and biological products

作　　者：李雪梅[1] 萧惠来[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2011年第6期493-496,共4页Chinese Journal of New Drugs

摘　　要：目前我国药品注册申请人药品说明书起草的质量良莠不齐。2010年3月FDA颁布了《人用处方药和生物制品说明书的用法用量部分指导原则》,对如何撰写说明书用法用量项目有详尽的描述。目前我国还没有类似细化的指导原则,主要在《化学药品、生物制品说明书指导原则(第二稿)》、《化学药品和治疗用生物制品说明书规范细则》中对说明书的形式与内容方面提出了一些基本要求。文中介绍了FDA指导原则要点,希望对我国说明书用法用量部分的撰写、监管和使用有所启迪。By reviewing the product labeling currently proposed by the new drug applicants,the quality of product labeling seems to vary in different levels.On March 2010,US FDA issued ＂ Guidance for industry：dosage and administration section of labeling for human prescription drug and biological products＂ and provided guidance in details on what categories of information should be included in the section of dosage and administration.In China,there are some basic requirements on product labeling format and content in the version 2 of ＂Guidance on the product labeling of chemical drugs and biological drugs＂ as well the ＂Details of guidance on the product labeling of chemical drugs and treatment biologic drugs＂.However,there is no guidance in such details for Chinese product labeling in comparison with the captioned US FDA guidance.The objective of this paper is to summarize the key messages of the captioned US FDA guidance in order to provide reference information for the development and administration of Chinese product labeling.

关 键 词：FDA 药品说明书 用法用量 指导原则 

分 类 号：R95[医药卫生—药学]