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[摘要]
处方药说明书是重要的沟通工具, 关系到药品的正确使用与患者的用药安全。介绍我国、美国食品药品管理局和欧盟药品管理局对处方药说明书[药物过量]项目撰写要点的有关要求, 并从报送到国家食品药品监督管理总局药审中心的说明书样稿中选取11个典型案例, 分析目前我国药品注册过程中该项目存在的问题。结果发现基本内容缺失是该项目存在的主要问题, 以此为鉴并且避免这些问题的出现对规范药品说明书撰写和有效监管大有裨益。
[Key word]
[Abstract]
The labeling for Prescription drug is an important communication tool, that is related to the correct use and drug safety of patients. The writing highlights of overdosage section of labeling for prescription drug required by CFDA, FDA and EMA are described. 11 typical cases are selected from the labeling drafts submitted to CFDA CDE for registration, and current problems of the section in process of drug registration of our country are analyzed. That lack of basic content is the main problem is found. Taking this as a lesson and avoiding these problems is of greater advantage to standardization of drug labeling and itseffective supervision.
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