【摘要】 目的:为我国完善和发展药品标签和说明书的管理提供借鉴。方法:采用非接触性研究中的内容分析方法,主要资料是从美国食品与药品管理局网站上收集的有关美国管理药品标签和说明书的23个法律文件,其中7个法律、1个联邦法规和15个指导准则。结果:美国药品标签和说明书是按处方药和非处方药分类管理,重点是对内容与格式的监管。结论:美国已建立了一套完整的法律体系管理药品标签和说明书,我国应从中得到启示,保证药品标签和说明书的信息全面、客观、准确,确保药品安全、有效地使用。更多还原

【Abstract】 OBJECTIVE: To provide references for the evolvement of the administration of drug labels and package inserts in China. METHODS: By content analysis in non-contact research, 23 law documents relevant to American drug labels and package inserts were collected from FDA website, of which, 7 were acts, 1 federal regulation and 15 guiding principles RESULTS: The drug labels and package inserts of the prescription drugs and the over-the-counter drugs in US were administrated in classification with an emphasis on the contents and formats. CONCLUSIONS: A set of comprehensive lawful system for drug labels and package inserts has been established in American, from which China should draw experience to ensure the comprehensiveness, objectiveness and accuracy of drug information and guarantee safety and efficacy of drugs.更多还原