Article(id=1291707011247399032, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.24.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1755705600000, receivedDateStr=2025-08-21, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896550236, onlineDateStr=2026-08-05, pubDate=1766851200000, pubDateStr=2025-12-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896550236, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896550236, creator=13701087609, updateTime=1785896550236, updator=13701087609, issue=Issue{id=1291706966187991876, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='24', pageStart='3451', pageEnd='3600', issueExtLink='null', onlineDate='null', pubDate='1766851200000', pubDateStr='2025-12-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896539494, creator='13701087609', updateTime=1785998798662, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292135872292479273, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292135872296673578, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3580, endPage=3587, ext={EN=ArticleExt(id=1291707011520028793, articleId=1291707011247399032, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Introduction to the patient medication information for prescription drugs in the US, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

To give patients a more scientific instruction of prescription drugs, drug regulatory authorities in developed countries such as Europe, the United States, and Japan are actively promoting the establishment of patient labeling system. Unlike professional labeling, patient labeling uses easy-to-understand language to help patients understand the most critical information about the drug, thereby enabling safer use of prescription drugs. This article focuses on the U.S. Food and Drug Administration(FDA)′s patient labeling system, briefly introducing the main content and relevant requirements of different types of patient labeling, such as the medication guides (MG), patient package inserts (PPI), instructions for use (IFU), and consumer medication information (CMI). It also provides a detailed introduction to the scope of application, specific content, and format requirements of the patient medication information (PMI) that the FDA is currently promoting, while giving a brief explanation of the patient labeling systems of other drug regulatory authorities (such as the European Union and Japan). PMI is a new form of patient labeling further optimized by the FDA based on previous experience in patient labeling work, and it plans to gradually unify and replace the original MG and PPI. In China, the State Council issued and implemented the Law of the People′s Republic of China on the Construction of Accessible Environments in 2023, requiring drug manufacturers and operators to provide labels and instructions in accessible formats such as audio, large print, braille, and electronic versions. In the same year, the National Medical Products Administration (NMPA) issued a public notice to promote the pilot work on aging-friendly labeling. By sorting out and summarizing the practical experience of the FDA′s patient labeling system and comparing it with the current pilot work on aging-friendly labeling in China, this article provides insights and references for promoting the establishment of a patient labeling system in China.

, authors=Fan ZHANG, Meng-die ZHOU, Zhen-yu XU, authorsList=Fan ZHANG, Meng-die ZHOU, Zhen-yu XU, authorCompany=null, correspAuthors=Zhen-yu XU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291707011796852858, articleId=1291707011247399032, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=美国处方药患者用药信息制度简介, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

为了更好地指导患者科学使用处方药，欧美日等发达国家药品监管机构都在积极推动建立患者药品说明书制度。不同于专业版的药品说明书，患者说明书通过通俗易懂的语言，帮助患者了解与药品相关的最重要的信息，从而使患者更加安全的使用处方药。本文围绕美国食品药品监督管理局（FDA）的患者说明书制度，简要介绍了FDA的用药指南（MG）、包装内患者说明书（PPI）、使用指南（IFU）和消费者用药信息（CMI）等不同类型患者说明书的主要内容及相关要求，并对FDA近期正在推进的患者用药信息（PMI）的适用范围、具体内容和格式要求等进行了详细介绍，同时对其他药品监管机构（如欧盟、日本）患者说明书制度进行了简单说明。PMI是一种新的患者说明书的形式，FDA在总结此前患者说明书工作经验的基础上进一步优化，并计划逐步统一和取代原有的MG、PPI。在我国，2023年国务院发布实施了《中华人民共和国无障碍环境建设法》，要求药品生产经营者要提供语音、大字、盲文、电子等无障碍格式版本的标签、说明书。同年，国家药品监督管理局（NMPA）发布公告，推动开展了说明书适老化试点工作。本文通过梳理总结FDA患者说明书的实践经验，与我国目前试行的说明书适老化相关工作进行对比，为推动我国建立患者说明书制度提供借鉴和参考。

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张帆（1990-），女，主管药师，主要从事药品审评项目管理与药品法规政策研究

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张帆（1990-），女，主管药师，主要从事药品审评项目管理与药品法规政策研究

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