美國食品藥品管理局（FDA）于2016年8月發(fā)布了“全身用抗菌藥的微生物學(xué)數(shù)據(jù)——產(chǎn)生、分析和描述的供企業(yè)用指導(dǎo)原則”，詳細(xì)介紹了FDA對抗菌藥微生物學(xué)研究全過程的要求。該指導(dǎo)原則對我國抗菌藥微生物學(xué)研究和監(jiān)管都有重要的參考價值，以下內(nèi)容尤其值得關(guān)注：對體外抗菌藥敏感性試驗（AST）方法、質(zhì)量控制（QC）參數(shù)和AST解釋標(biāo)準(zhǔn)的要求，對說明書微生物學(xué)項目格式和內(nèi)容的要求，對抗菌藥上市后定期評價和更新說明書體外AST方法、QC參數(shù)和AST解釋標(biāo)準(zhǔn)的要求，對體外敏感性試驗分離菌株數(shù)量和致病菌特點的要求。

FDA in August 2016 released "Microbiology Data for Systemic Antibacterial Drugs-Development, Analysis, and Presentation Guidance for Industry", which introduced requirements of the whole process of the research on the microbiology of systemic antimicrobial drugs by FDA. Therefore, the guidance of FDA has an important reference value for the research and supervision of the systemic antimicrobial drugs in our country. The following are particularly noteworthy:requirements for the in vitro AST methods, the QC parameters and the AST interpretive criteria; Requirements for the format and content of the labeling microbiology portion; requirements for periodic evaluation and update of the in vitro AST methods, the QC parameters, and the AST interpretive criteria in postmarketing labeling; Requirements for the number of isolates and the characteristics of pathogenic bacteria for in vitro sensitivity test.