FDA Adverse Event Reporting System (FAERS) Electronic Submissions – E2B(R2) Standards

This page provides industry information and instructions on how to electronically submit postmarketing individual case safety reports (ICSRs) for human drugs, including biological products regulated by CDER, using E2B(R2) standards. Companies submitting postmarketing ICSRs to FAERS may continue using E2B(R2) standards for  (2) years during the E2B(R3) implementation period. Once your company has begun submitting in the E2B(R3) standard, your company may not revert to legacy methods and/or standards.

FDA has only accepted electronic submissions of ISCRs in the XML format if prepared in accordance with International Conference on Harmonisation-E2B (ICH E2B) to transmit information directly from database-to-database using standardized (ICH E2B(M)) data elements.

To submit ICSRs using database-to-database transmission in E2B(R2) format:

• ICSRs must be submitted in the XML format to FDA via the Electronic Submissions Gateway (ESG).
• Attachments must be in the pdf format. Attachments to ICSRs may include supporting information for ICSRs such as relevant hospital discharge summaries, autopsy reports, death certificates, and published articles for ICSRs based on scientific literature.
• See document “Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments".
• For additional instruction on how to begin submitting ICSRs in the XML format, go to the document titled, "Steps to Submitting E2B(R2) ICSRs Electronically in the XML Format."