美國食品藥品監(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明書的用法用量項目——內容和格式”的供企業(yè)用的指導原則草案，同時撤回了2010年3月發(fā)布的“人用處方藥和生物制品說明書的用法用量項目——內容和格式”的供企業(yè)用的指導原則。目的是幫助申請人，確保藥品說明書“用法用量”項目包括安全有效使用藥物所需的用法用量相關信息，并且將信息清晰、簡潔并以相關和易于理解的方式呈現給醫(yī)療人員。該指導原則詳細而具體地介紹了“用法用量”項目的撰寫要求并附有示例，其中主要包括對說明書該項目撰寫的基本原則和對該項目各種具體內容的撰寫要求。而中國目前尚沒有類似的指導原則，詳細介紹 FDA 該指導原則，以期對我國藥品說明書該項目的撰寫有參考價值，也有助于對該方面的監(jiān)管更加有的放矢。因為FDA該指導原則篇幅較長，分上下2篇進行介紹，本期發(fā)表下篇。

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"Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format draft guidance for industry" in January 2023, and withdrew the "Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content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, second article published in this issue.

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