介紹歐盟和美國(guó)有關(guān)藥品說(shuō)明書(shū)[適應(yīng)癥]項(xiàng)目撰寫(xiě)的法規(guī)和指導(dǎo)原則，特別是最近歐洲藥品管理局（EMA）發(fā)布的"治療適應(yīng)癥的用語(yǔ)"。從這些管理文件得到的啟示是相關(guān)法規(guī)規(guī)定不宜太粗糙，應(yīng)具體、精準(zhǔn)，應(yīng)包括內(nèi)容和格式的規(guī)定；而且要有指導(dǎo)原則伴隨，以保證法規(guī)落到實(shí)處。熟悉掌握藥品說(shuō)明書(shū)[適應(yīng)癥]項(xiàng)目的撰寫(xiě)要求對(duì)規(guī)范撰寫(xiě)其他項(xiàng)目有普遍指導(dǎo)意義，對(duì)于藥品說(shuō)明書(shū)的監(jiān)管也有裨益。

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.

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