美国药品标识类型和要求研究

On Types and Requirements of FDA Drug Labeling

目的:通过回顾美国药品标签和说明书监管历程,阐述美国药品标识类型和要求,以期为完善我国药品说明书和标签管理提供借鉴,进一步提高卫生专业人员和公众合理用药水平。方法:查询FDA及美国联邦政府的官方网站、中国知网数据库,采用对比分析和统计分析等研究方法,对美国药品标识分类和要求进行分析。结果与结论:美国药品标识围绕目标人群的专业水平、药品使用风险差异两大监管原则,逐步形成了类型丰富、层次鲜明、内容详实的药品标识群。我国药品说明书和标签监管制度,可以从进一步明确我国药品说明书和标签的功能定位、加强对处方药和非处方药说明书和标签的管理等方面,借鉴美国处方药和非处方药标识的管理经验。

Objective： To provide references for improving the management of drug labeling and package insert in China and the level of rational drug use of health professionals and the public through reviewing the regulatory history of FDA drug labeling and package insert and introducing the types and requirements of FDA drug labeling. Methods： FDA, US federal government＇s official website and CNKI were searched. The types and requirements of FDA drug labeling were analyzed using the methods of comparative analysis and statistical analysis. Results and Conclusion： FDA drug labeling gradually formed a diversified, distinct level and detailed contents of drug identification group based on two regulatory principles, i.e. professional level of target population and differences of medication risk. Regulatory system of package insert and drug labeling in China should learn from the management experiences of FDA prescription drug and OTC drug labeling to further clarify the following management aspects, such as function positioning of package insert and drug labeling, and the improvement of management of the prescription drug and OTC package insert and drug labeling.