美国FDA警告信的制度模式介绍  

Introduction to the system model of U.S. FDA warning letters

作　　者：何辉 周刚 HE Hui;ZHOU Gang(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2025年第5期473-476,共4页Chinese Journal of New Drugs

摘　　要：美国FDA警告信作为一种重要的监管工具,在美国药品市场中发挥关键作用,旨在监督和确保药品生产企业遵守严格的生产和质量标准,以保障消费者的健康和安全。本文旨在系统介绍美国FDA警告信的起源、法律性质、适用范围和签发程序,探讨了在新形势下推进监管科学创新发展的关键问题以及该制度对促进我国药品监管高水平发展的借鉴意义。Warning letters from the U.S.FDA serve as the critical regulatory tools in the American pharmaceutical market.They are designed to supervise and ensure that the drug companies adhere to the strict production and quality standards,aiming to safeguard the consumers health and safety.This article aims to systematically introduce the origins,legal nature,scope of application,and issuance procedures of U.S.FDA warning letters,and to explore the relevance of this system for advancing regulatory science and promoting a high-level development in drug regulation in China under new conditions.

关 键 词：警告信 药品监管 合规 

分 类 号：R95[医药卫生—药学]