國(guó)家藥品監(jiān)督管理局于2018年5月發(fā)布了“抗菌藥說(shuō)明書(shū)撰寫(xiě)技術(shù)指導(dǎo)原則”。該指導(dǎo)原則極其詳細(xì)地說(shuō)明了抗菌藥說(shuō)明書(shū)各個(gè)項(xiàng)目應(yīng)包含的內(nèi)容及其撰寫(xiě)格式，為提高這類藥品說(shuō)明書(shū)的質(zhì)量提供了保障。通過(guò)阿奇霉素片等4個(gè)實(shí)例，以該指導(dǎo)原則為準(zhǔn)繩，與美國(guó)食品藥品管理局（FDA）核準(zhǔn)的同品種說(shuō)明書(shū)進(jìn)行比較，分析我國(guó)藥品說(shuō)明書(shū)存在的問(wèn)題，期望對(duì)理解和落實(shí)指導(dǎo)原則，起草或修訂抗菌藥品說(shuō)明書(shū)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.