FDA对全身用抗菌药说明书敏感性试验解释标准管理的新举措——互联网+STIC

最近美国食品药品管理局（FDA）建立了抗菌药敏感性试验解释标准（STIC）网页，同时规定药品说明书不再列出STIC相关资料，而改为告知查询该网页，从而加速STIC信息传递，促进临床合理选用抗菌药。为此，FDA于2017年12月发布了《全身用抗菌和抗真菌药物：NDAs和ANDAs说明书敏感性试验解释标准指导原则》，详细介绍该指导原则的主要内容，以期我国早日实施这种高效的互联网+STIC管理模式。

New measures for management of susceptibility test interpretive criteria package insert for systemic antibacterial and antifungal drugs by FDA

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.