[关键词]
[摘要]
介绍欧盟和美国有关药品说明书[适应症]项目撰写的法规和指导原则,特别是最近欧洲药品管理局(EMA)发布的"治疗适应症的用语"。从这些管理文件得到的启示是相关法规规定不宜太粗糙,应具体、精准,应包括内容和格式的规定;而且要有指导原则伴随,以保证法规落到实处。熟悉掌握药品说明书[适应症]项目的撰写要求对规范撰写其他项目有普遍指导意义,对于药品说明书的监管也有裨益。
[Key word]
[Abstract]
This paper introduces the regulations and guidelines on the writing of indication section of drug labeling in the EU and the United States, especially the Wording of therapeutic indication published by EMA recently. The Enlightenment from these management documents is that the relevant regulations should not be too rough, they should be specific and accurate, and should include the provisions of content and format, and should be accompanied by guidelines to ensure the implementation of regulations. To be familiar with the writing requirements of indication section of drug labeling is of general guiding significance for standardizing the writing of other sections, and also beneficial to the supervision of drug labeling.
[中图分类号]
R951
[基金项目]