E2B(R3) is the ICH standard for transmitting individual case safety reports (ICSRs) electronically to regulators. FDA, EMA's EudraVigilance and Japan's PMDA accept it; in the US, reports land in FDA's Adverse Event Monitoring System (AEMS), which replaced FAERS on 11 March 2026. The E2B(R3) message is built and sent by the sponsor's safety database. Burna AI works upstream of that step and produces the content a case carries: each adverse event extracted from the note, graded to CTCAE, coded to a MedDRA LLT and attributed per drug with WHO-UMC and Kramer, with the source line attached. The reports Burna AI generates are the FDA MedWatch 3500A, the IRB unanticipated problem report and the sponsor SAE report. The same engine runs from first-in-human trials through postmarket surveillance, and burna.ai/capabilities is the dated record of what it produces today.
More on regulatory reporting.
- Does Burna AI generate regulatory reports such as FDA MedWatch, IRB and SAE reports?
- Does Burna AI code adverse events to MedDRA?
- What is a SUSAR in clinical trials, and when must it be reported?
- What is an ICSR (individual case safety report) in pharmacovigilance?
- Which safety reports does pharmacovigilance require, from ICSRs to DSURs and PBRERs?
- How does Burna AI handle 21 CFR Part 11 electronic records and signatures?