最近美國食品藥品管理局（FDA）建立了抗菌藥敏感性試驗(yàn)解釋標(biāo)準(zhǔn)（STIC）網(wǎng)頁，同時(shí)規(guī)定藥品說明書不再列出STIC相關(guān)資料，而改為告知查詢?cè)摼W(wǎng)頁，從而加速STIC信息傳遞，促進(jìn)臨床合理選用抗菌藥。為此，F(xiàn)DA于2017年12月發(fā)布了《全身用抗菌和抗真菌藥物：NDAs和ANDAs說明書敏感性試驗(yàn)解釋標(biāo)準(zhǔn)指導(dǎo)原則》，詳細(xì)介紹該指導(dǎo)原則的主要內(nèi)容，以期我國早日實(shí)施這種高效的互聯(lián)網(wǎng)+STIC管理模式。

Currently, FDA built a web page for susceptibility test interpretive criteria at https://www.fda.gov/STIC. Meanwhile, the relevant material of STIC will no longer be listed on the package insert. Instead, it's advised to check the page. Thus, this accelerates the transmission of STIC information and promotes the rational selection of antimicrobials as well. Therefore, FDA announced systemic antibacterial and antifungal drugs:susceptibility test interpretive criteria package insert for NDAs and ANDAs guidance for industry in December 2017. This paper introduces the main content of the guideline. We look forward to the early implementation of this efficient Internet + STIC management model in our country.