介绍我国国家食品药品监督管理总局、美国食品药品管理局和欧洲药品局对处方药说明书中[适应症]项目撰写要点的要求.并以这些要求和其他有效而安全用药要求作为尺度,分6个方面分析了在我国提交药品注册申请时报送的61例的不符合上述要求的说明书样稿,结合11个典型实例概述了目前存在的主要问题,包括进口药和跨国公司在华药厂的药品说明书样稿,指出不符合以上要求以及违背有效且安全用药基本原则的现象,有助于药品说明书的规范撰写和保障安全用药.

The writing highlights of indication section of labeling for prescription medicine required by CFDA, FDA, and EMA are described. Based on the above requirements as well as other demands related to effective- and safe-using drugs, the paper analyzes the typical cases of labeling drafts submitted for registration in our country from six aspects, discussing with the eleven typical representatives to overview the current problems, including the labeling drafts of import medicine and multi-national corporation, in order to reveal the manifestations that do not meet these requirements and against the basic principles for effective and safe medication. It is expected to be helpful to write the normal labeling of drugs and ensure safe medication in China.