With the ongoing globalization of the pharmaceutical industry, efforts to harmonize technical requirements of registering drugs and biologics, including vaccines, have produced a number of useful guidelines utilized around the world. However, such efforts have not been extended to the regulatory review process or product labeling. Prescribing information and patient information leaflet are two types of such product labeling documents. This study examined the differences in the languages of these documents between the United States (US) and European Union (EU). The key documents examined were the U.S. Food & Drug Administration’s (FDA) Package Inserts (PIs), U.S. Centers for Disease Control and Prevention’s (CDC) Vaccine Information Statements (VISs), and the European Medicines Agency’s (EMA) Summary of Product Characteristics (SmPCs) and Package Leaflets (PLs). Prescribing information and patient information leaflet languages were subsequently organized into ten and seven categories, respectively. Comparison of FDA PIs to EMA SmPCs showed little harmonization between the two regions, and CDC VISs to EMA PLs revealed even less.

随着制药业的不断全球化，为统一注册包括疫苗在内的药物和生物制剂的技术要求而做出的努力已产生了许多在世界范围内使用的有用指南。但是，此类工作尚未扩展到法规审查过程或产品标签。处方信息和患者信息传单是此类产品标签文档的两种类型。这项研究检查了美国（US）和欧盟（EU）之间这些文件的语言差异。审查的主要文件包括美国食品药品监督管理局（FDA）的包装说明书（PIs），美国疾病预防控制中心（CDC）的疫苗信息声明（VISs），以及欧洲药品管理局（EMA）的产品特征摘要（SmPC）和包装传单（PL）。处方信息和患者信息传单的语言随后分别分为十类和七类。FDA PI与EMA SmPC的比较显示这两个区域之间几乎没有统一，而CDC VIS与EMA PL的揭示甚至更少。