Definition

A medicinal product that is suspected of causing or contributing to the reported adverse event, as determined by the reporter or safety assessor.

Example

A patient on three medications develops liver injury. After assessment, one drug is classified as 'suspect' based on its known hepatotoxicity profile, while others are classified as concomitant.

Regulatory source

ICH E2B(R3)

Common mistakes

Classifying all medications as suspect when clinical judgment and temporal relationship suggest only one is likely causal.

Inspector question

What criteria do you use to determine suspect vs concomitant drug classification?

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