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# FDA Releases ICH Regional Specs for Adverse Event Reporting
- URL: https://www.fdaweb.com/fda-releases-ich-regional-specs-for-adverse-event-reporting/
- Published: 2016-06-23T12:00:00.000Z
- Updated: 2026-09-14T21:11:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136039

*Federal Register* Notice: FDA is making available its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonization (ICH) E2B(R3) Specification. It is making this document available to assist interested parties in electronically submitting individual case safety reports and attachments to CDER and 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. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-23/pdf/2016-14845.pdf?ref=fdaweb.com)