Definition

Safety reports submitted at regular intervals (e.g., annually) providing cumulative analysis of a product's safety profile.

Example

PSURs are submitted every 6 months for newly approved products, annually for established products, or at other intervals specified in the pharmacovigilance plan.

Regulatory source

ICH E2C(R2), EU GVP Module VII

Common mistakes

Missing submission deadlines due to complex interval calculations or not tracking birth dates correctly.

Inspector question

How do you manage periodic report submission schedules? Show me your tracking system.

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