Fed Regist. 2014 Jun 10;79(111):33072-92.
The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
美国食品药品监督管理局（FDA或我们）正在修订其关于人用药品和生物制品上市后安全报告的法规，要求必须遵守报告要求的人员以电子格式提交安全报告，以便FDA能够进行处理、审查和存档。FDA采取这一行动是为了改进该机构收集和分析上市后安全报告的系统。这一变化将有助于该机构更快地审查上市后安全报告，识别新出现的安全问题，并传播安全信息，以支持FDA的公共卫生使命。此外，这些修订将是使FDA的上市后安全报告法规与安全信息电子提交国际标准相协调的关键要素。
