Fed Regist. 2016 Jun 23;81(121):40890-1.
The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.
美国食品药品监督管理局（FDA）宣布提供其针对国际协调会议（ICH）E2B（R3）规范的FDA不良事件报告系统（FAERS）区域实施规范。FDA提供此技术规范文件，以协助相关方以电子方式向药品评估与研究中心（CDER）和生物制品评估与研究中心（CBER）提交个例安全报告（ICSRs）（及ICSR附件）。这份题为《FDA关于ICH E2B（R3）实施的区域实施规范：药品和生物制品（不包括疫苗）个例安全报告的上市后提交》的文件补充了《E2B（R3）个例安全报告（ICSRs）的电子传输实施指南——数据元素和消息规范》这一行业最终指南，并描述了FDA接收ICSRs、纳入区域控制术语以及在向FAERS报告时添加特定区域数据元素的技术方法。
