Definition

FDA requirement (April 2026) for structured electronic submission of adverse events in ICH E2B(R3) format; replaces older formats for FAERS.

Example

XML-based ICSR submission to FDA in E2B(R3) after April 2026.

Regulatory source

FDA E2B(R3) Implementation (April 2026)

Common mistakes

Missing the deadline and continuing to submit in legacy format.

Inspector question

What is your E2B(R3) implementation status for FDA?

Related terms