Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule

摘要

The Food and Drug Administration (FDA or we) is announcing an updated data standard requirement for the submission of postmarketing individual case safety report (ICSR) submissions for human drug products, biological products, and drug- or biologic-led combination products to the FDA Adverse Event Monitoring System (AEMS) database (formerly FDA Adverse Event Reporting System (FAERS)) via the Electronic Submissions Gateway Next Generation (ESG NextGen). Starting October 1, 2026, postmarketing ICSRs must be reported using the data standards adopted by FDA in the International Council for Harmonisation (ICH) guidance for industry entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" (ICH E2B(R3) Implementation Guidance), which incorporates by reference regional implementation guides (collectively ICH E2B(R3) data standards).