FDA Requires New Electronic Standards for Postmarketing Safety Reports
Published Date: 4/6/2026
Notice
Summary
Starting October 1, 2026, drug and biologic companies must send safety reports to the FDA using a new, updated electronic format called ICH E2B(R3). This change affects anyone submitting postmarketing safety info and helps the FDA spot problems faster and more clearly. The switch means companies need to update their systems but will improve how safety data is shared nationwide.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
ICH E2B(R3) Required October 1, 2026
Starting October 1, 2026, companies must submit postmarketing individual case safety reports (ICSRs) for human drug products, biological products, and drug- or biologic-led combination products to the FDA Adverse Event Monitoring System (AEMS) via the Electronic Submissions Gateway Next Generation (ESG NextGen) using the ICH E2B(R3) data standards. FDA will continue to accept the older ICH E2B(R2) format through September 30, 2026.
Better FDA Data Handling and Analysis
FDA states the ICH E2B(R3) standards were issued to improve the quality of data in ICSR submissions and to enable improved handling and analyses of ICSRs. Improved data quality and handling are intended to help FDA manage and analyze postmarketing safety reports more effectively.
SRP Option for Non‑R3 Capable Submitters
Companies that do not have ICH E2B(R3) capability can submit postmarketing ICSRs and attachments through the Safety Reporting Portal (SRP). This notice requiring ICH E2B(R3) applies only to submissions made through ESG NextGen.
R3 Changes to Data Elements and Format
ICH E2B(R3) includes new, changed, and expanded data elements, requires assessment of seriousness at the event level rather than the case level, and embeds attachments inside the ICSR rather than providing them separately. These format and content changes affect how companies must prepare and structure their safety reports.
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