美國(guó)食品藥品監(jiān)督管理局（FDA）于2023年1月發(fā)布了“人用處方藥和生物制品說(shuō)明書(shū)的用法用量項(xiàng)目——內(nèi)容和格式”的供企業(yè)用的指導(dǎo)原則草案，同時(shí)撤回了2010年3月發(fā)布的“人用處方藥和生物制品說(shuō)明書(shū)的用法用量項(xiàng)目——內(nèi)容和格式”的供企業(yè)用的指導(dǎo)原則。目的是幫助申請(qǐng)人，確保藥品說(shuō)明書(shū)“用法用量”項(xiàng)目包括安全有效使用藥物所需的用法用量相關(guān)信息，并且將信息清晰、簡(jiǎn)潔并以相關(guān)和易于理解的方式呈現(xiàn)給醫(yī)療人員。該指導(dǎo)原則詳細(xì)而具體地介紹了“用法用量”項(xiàng)目的撰寫(xiě)要求并附有示例，其中主要包括對(duì)說(shuō)明書(shū)該項(xiàng)目撰寫(xiě)的基本原則和對(duì)該項(xiàng)目各種具體內(nèi)容的撰寫(xiě)要求。而中國(guó)目前尚沒(méi)有類似的指導(dǎo)原則，詳細(xì)介紹 FDA 該指導(dǎo)原則，以期對(duì)我國(guó)藥品說(shuō)明書(shū)該項(xiàng)目的撰寫(xiě)有參考價(jià)值，也有助于對(duì)該方面的監(jiān)管更加有的放矢。因?yàn)镕DA該指導(dǎo)原則篇幅較長(zhǎng)，將分上下2篇進(jìn)行介紹，本期發(fā)表上篇。

The US Food and Drug Administration (FDA) issued the "Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format draft guidance for industry" in January 2023, and withdrew the "Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format guidance for industry " issued in March 2010. Its purpose is to assist applicants in ensuring that the dosage and administration section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners. This guidance introduces the requirements for writing dosage and administration section in extremely detailed and specific manner with examples, which mainly includes the basic principles for writing the section in the labeling and the requirements for writing various specific contents of the section. At present, there is no similar guidance in China. This article introduces the FDA guidance in detail. The guidance of FDA have a good reference value for the writing of the drug labeling section in China, and also contribute to the more targeted supervision of this aspect in China. Because the length of this guidelines is long, the introduction will be divided into two parts, first article published in this issue.