Federal Register #2026-06660

FDA Mandates Electronic Submission of Postmarketing Safety Reports Using ICH E2B(R3) Standards

This notice from the Food and Drug Administration (FDA) outlines new technical requirements for submitting postmarketing Individual Case Safety Reports (ICSRs): - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Requirement Overview: - All postmarketing ICSRs for human drug products, biological products, and drug- or biologic-led combination products must be submitted electronically - Submissions must use the International Council for Harmonisation (ICH) E2B(R3) data standards - Reports are to be sent via the Electronic Submissions Gateway Next Generation (ESG NextGen) to the FDA Adverse Event Monitoring System (AEMS) - Technical Guidance: - References the ICH E2B(R3) Implementation Guidance and FDA Regional Implementation Guide - Emphasizes harmonization with international safety reporting standards - Notable Requirements: - No specific OEMs, vendors, or products are being procured - The notice is a regulatory update, not a solicitation for goods or services - Compliance with the new data standards is mandatory for all relevant submissions - Locations: - FDA headquarters and specified Silver Spring, MD address for regulatory correspondence

Description

The Food and Drug Administration (FDA) announces an updated data standard requirement for submitting postmarketing individual case safety reports (ICSRs) for human drug products, biological products, and combination products to the FDA Adverse Event Monitoring System (AEMS) database via the Electronic Submissions Gateway Next Generation (ESG NextGen). Starting October 1, 2026, all postmarketing ICSRs must be submitted using the International Council for Harmonisation (ICH) E2B(R3) data standards. This update aims to improve data quality and harmonize safety reporting standards internationally, with detailed guidance and technical specifications provided by the FDA.

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