Definition

The ICH standardized electronic format for transmitting Individual Case Safety Reports between pharmaceutical companies, regulatory authorities, and other stakeholders.

Example

A company submits an expedited report to the FDA in E2B(R3) format, which allows automated import into the FDA's Adverse Event Reporting System (FAERS).

Regulatory source

ICH E2B(R3)

Common mistakes

Not validating E2B files before submission, leading to rejection. Files must pass validation rules for acceptance.

Inspector question

What is your E2B validation process? How do you handle rejected submissions?

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