FDA Mandates New Digital Format for Drug Safety Reports Starting 2026
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 track drug safety better and faster. Companies should get ready to switch to this new system to keep their reports accepted without delays or extra costs.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
Mandatory ICH E2B(R3) Format
If your company submits postmarketing individual case safety reports (ICSRs) to the FDA via the Electronic Submissions Gateway Next Generation (ESG NextGen), beginning October 1, 2026 you must submit ICSRs using the ICH E2B(R3) data standards. FDA intends to stop accepting the older ICH E2B(R2) format after September 30, 2026.
R3 Changes Data Structure and Fields
ICH E2B(R3) includes new, changed, and expanded data elements; it requires assessing seriousness at the event level (not the case level); and it embeds attachments inside the ICSR rather than providing them separately. You may need to update data collection, recordkeeping, and submission processes to match these changes.
SRP Remains Alternative Option
The ICH E2B(R3) requirement in this notice applies only to submissions made through ESG NextGen. Companies that do not have ICH E2B(R3) capability can submit ICSRs and ICSR attachments using the Safety Reporting Portal (SRP).
All Reports Must Use R3 After Transition
Once your company begins submitting ICSRs in the ICH E2B(R3) format, all subsequent ICSR submissions are expected to use ICH E2B(R3).
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