美国食品药品监督管理局（FDA）于2023年1月发布了“人用处方药和生物制品说明书的用法用量项目——内容和格式”的供企业用的指导原则草案，同时撤回了2010年3月发布的“人用处方药和生物制品说明书的用法用量项目——内容和格式”的供企业用的指导原则。目的是帮助申请人，确保药品说明书“用法用量”项目包括安全有效使用药物所需的用法用量相关信息，并且将信息清晰、简洁并以相关和易于理解的方式呈现给医疗人员。该指导原则详细而具体地介绍了“用法用量”项目的撰写要求并附有示例，其中主要包括对说明书该项目撰写的基本原则和对该项目各种具体内容的撰写要求。而中国目前尚没有类似的指导原则，详细介绍 FDA 该指导原则，以期对我国药品说明书该项目的撰写有参考价值，也有助于对该方面的监管更加有的放矢。因为FDA该指导原则篇幅较长，分上下2篇进行介绍，本期发表下篇。

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and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format draft guidance for industry" in January 2023, and withdrew the "Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content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

R951