Definition

A comprehensive assessment of the risk-benefit balance of a medicinal product submitted at defined intervals throughout its marketed life.

Example

The annual PSUR for Drug X includes: estimated exposure, cumulative adverse reaction tables, signal evaluation summary, benefit-risk analysis, and proposed actions.

Regulatory source

ICH E2C(R2), EU GVP Module VII

Common mistakes

Treating PSURs as simple data compilations rather than analytical documents requiring benefit-risk conclusions.

Inspector question

Walk me through your PSUR preparation process. How do you conduct the benefit-risk evaluation?

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