美国FDA药品生产质量监管体系

US FDA's regulatory system for drug manufacturing quality

美国食品药品监督管理局(Food and Drug Administration,FDA)作为全球药品监管机构的领先者,具备先进的科学和完善的法规体系及合理的机构设置和有效的运行机制。本文针对药品生产质量监管,剖析FDA注册审评、现场检查及合规审评三方面职能,讨论其部门设置和职能划分、运行机制,及资源配置和技术支持,为药监部门加强科学监管提供借鉴,也为企业了解美国FDA药品生产质量监管体系并与其有效沟通提供参考。

As a global leader in pharmaceutical regulation, the US Food and Drug Administration （FDA） is known for its well developed scientific capability, legal and regulatory foundation, organizational setup and opera tional experience. This work analyzes FDA＇s regulatory system for drug manufacturing quality from the program per spectives of application review, GMP inspection and compliance review by focusing on organizational and functional setup, operational mode, resource allocation and program support. The outcome of this work can serve as a refer ence for regulatory agencies to strenghten sciencebased regulation, and for drug manufacturers to gain program knowledge and improve communication with the FDA