國家藥品監(jiān)督管理局于2018年5月發(fā)布了“抗菌藥說明書撰寫技術(shù)指導(dǎo)原則”。該指導(dǎo)原則極其詳細地說明了抗菌藥說明書各個項目應(yīng)包含的內(nèi)容及其撰寫格式，為提高這類藥品說明書的質(zhì)量提供了保障。通過阿奇霉素片等4個實例，以該指導(dǎo)原則為準(zhǔn)繩，與美國食品藥品管理局（FDA）核準(zhǔn)的同品種說明書進行比較，分析我國藥品說明書存在的問題，期望對理解和落實指導(dǎo)原則，起草或修訂抗菌藥品說明書有所幫助。

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.