Definition

An adverse event case identified through published medical or scientific literature that mentions the company's product in association with an adverse event.

Example

A case report published in a medical journal describes anaphylaxis in a patient taking Drug X. The MAH must capture this as an ICSR if it involves their product.

Regulatory source

ICH E2D Section 2.4, EU GVP Module VI

Common mistakes

Only monitoring major journals. Regulatory expectations include systematic monitoring of global literature including regional publications.

Inspector question

Describe your literature monitoring process. How frequently do you search, and what databases do you use?

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