FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products

The purpose of this technical specifications document is to assist submitters electronically submitting individual case safety reports (ICSRs) and ICSR attachments to FDA Adverse Event Reporting System (FAERS) database.

This document describes FDA’s technical approach for submitting ICSRs, for incorporating its regionally controlled terminology, and for adding FAERS regional data elements that are not addressed in the International Conference on Harmonization’s (ICH) E2B(R3) Implementation Guideline (IG), including the following FDA-regulated products:

• Drug products marketed for human use with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs)
• Prescription drug products marketed for human use without an approved application
• Nonprescription human drug products marketed without an approved application)
• Biological products marketed for human use with approved biologic license applications (BLAs).