不符合指导原则要求的抗菌药说明书实例讨论

国家药品监督管理局于2018年5月发布了“抗菌药说明书撰写技术指导原则”。该指导原则极其详细地说明了抗菌药说明书各个项目应包含的内容及其撰写格式，为提高这类药品说明书的质量提供了保障。通过阿奇霉素片等4个实例，以该指导原则为准绳，与美国食品药品管理局（FDA）核准的同品种说明书进行比较，分析我国药品说明书存在的问题，期望对理解和落实指导原则，起草或修订抗菌药品说明书有所帮助。

Discussions on examples of antimicrobial drug labeling that for non-compliance with requirements of the Guideline

The State Drug Administration (SDA) issued the Guideline for the Writing of Antimicrobial Labeling in May 2018. The guideline describe the contents and format of each section in the antimicrobial labelling in great detail, and provide a guarantee for improving the quality of the labeling. This paper analyzes the problems existing in four examples (such as Zithromax) of the labeling in China, according to this guideline, compared with the labeling of the same variety approved by FDA. It is expected to be helpful in understanding and implementing the guideline and in drafting or revising such labeling.