US FDA is now accepting electronic submission of IND ICSRs

The United States Food and Drug Administration (US FDA) is now accepting investigational new drug application (IND) individual case safety reports (ICSRs) submitted electronically via the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal. The agency recently published a guidance that finalizes the draft issued in October 2019, including minor revisions to improve clarity, with instructions for electronic submission of IND safety reports to the FDA Adverse Event Reporting System (FAERS).

Companies have until April 1, 2026, to prepare, but it would be advisable to start planning the necessary updates to their systems and processes as soon as possible and start submitting in the new format during the voluntary reporting period if possible. The process might require a lot of time and effort, depending on the complexity of the pharmacovigilance processes in place. However, once implemented, the new harmonized format for ICSR submissions will simplify global reporting and give sponsors confidence in the accuracy and consistency of safety data.