美国药品标识监管体系研究

目的：通过研究和分析美国药品说明书和标签监管体系,重点阐述现有监管制度上的环节要求,以期为完善我国药品说明书和标签监管体系提供较为全面的参考和借鉴,进一步提高用药安全水平。方法：采用非接触性研究中的内容分析方法,广泛查询FDA及美国联邦政府的官方网站、中国知网数据库等,收集整理与美国标识监管体系相关的资料,包括法律文件8个、指南36个及50余个FDA官网网页资料和报告文件等。结果与结论：围绕上市前、上市后和信息公开管理,并通过不断修订加强法律法规,美国药品标识逐步形成了法律、法规及指南3个层面的逻辑清晰的完整监管体系。我国药品说明书和标签监管体系建设工作相差明显,应尽快建立我国药品说明书和标签功能定位监管认识的新视角,完善上市前、上市后和信息公开管理制度机制,抓住《药品管理法》修订的契机,系统性安排药品说明书和标签立法工作计划,开展全国调研,为全面规范药品说明书和标签管理提供科学保障。

Study on FDA Regulatory System of Drug Labeling

Objective: To study and analyze food and drug administration (FDA) regulatory system of American package inserts and drug labelings, especially the requirements of current regulatory system in order to provide comprehensive references and recommendations for perfecting China''s regulatory system of package inserts and drug labelings and to improve the level of drug safety. Methods: The method of content analysis in noncontact research was used in this paper. Documents relevant to the FDA regulatory system of drug labelings were collected and collated by extensively searching the official websites of FDA and the US federal government, CNKI database, etc, among which 8 legal documents, 36 guidelines and more than 50 FDA official website webpage data and report documents were included. Results and Conclusion: FDA gradually formed a logic and complete drug regulatory system in laws, regulations and guidelines by the way of pre-market and post-market management, information publicity and constant revision of laws and regulations. There are obvious differences between China and USA in the regulatory system of drug labelings and package inserts. A new perspective for the regulation of drug labelings and package inserts of China should be formed as soon as possible. Management of pre-market, post-market and information disclosure should be improved. "Drug Administration Law" amendment should be taken as an opportunity to systematically make a legislative work plan for drug labelings and package inserts, to carry out the national investigation and research, and to lay a scientifc basis for the comprehensive management of drug labelings and package inserts.