Definition

The formal transmission of adverse event information to regulatory authorities through approved channels and formats.

Example

Submission may occur via electronic gateway (E2B), regulatory portal (EudraVigilance, FAERS), or in some cases paper forms for regions without electronic capability.

Regulatory source

ICH E2B(R3), Regional Requirements

Common mistakes

Using incorrect submission routes or formats for specific regulatory authorities.

Inspector question

Describe your submission infrastructure. What backup procedures exist if primary submission routes fail?

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