Pharmacovigilance

Periodic Safety Update Report(PSUR)

A periodic report summarizing the global safety profile of a marketed medicinal product.

Usage Examples

The PSUR identified a new safety signal requiring label update.
PSUR submission frequency was changed from 6-monthly to annual.
The benefit-risk assessment in the PSUR remained favorable.

What is PSUR?

A Periodic Safety Update Report (PSUR) is a comprehensive safety document that provides a periodic assessment of a medicinal product's benefit-risk profile. PSURs compile safety data from all sources worldwide, including clinical trials, post-marketing surveillance, and literature.

The ICH E2C(R2) guideline established the Periodic Benefit-Risk Evaluation Report (PBRER) as the international standard, which many regions have adopted. PSURs/PBRERs are submitted at defined intervals based on product approval status and may trigger regulatory actions if safety concerns are identified.

Report components include patient exposure data, adverse event summaries, signal evaluation, benefit-risk analysis, and any proposed changes to product information.

Regulatory Context

This term appears most often in pharmacovigilance workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside ICH E2C R2, 21 CFR 314 80, EU GVP MODULE VII.

FDAEMAWHO

When This Matters

The PSUR identified a new safety signal requiring label update.
PSUR submission frequency was changed from 6-monthly to annual.
The benefit-risk assessment in the PSUR remained favorable.

Common Mistakes

Treating safety signal reviews as periodic instead of continuous.
Not linking new enforcement letters to internal CAPA and labeling workflows.
Using static templates for dynamic benefit-risk communication updates.

Related Regulations

ICH E2C R221 CFR 314 80EU GVP MODULE VII

Frequently Asked Questions

PBRER (Periodic Benefit-Risk Evaluation Report) is the ICH E2C(R2) standard that replaced the original PSUR format. Many regions now use PBRER, though "PSUR" is still commonly used as a general term.

Frequency depends on approval status: typically every 6 months for new products, annually for the next 2-3 years, then every 3 years for established products. Regional requirements may vary.

Regulatory authorities may request unscheduled PSURs when significant safety concerns arise, such as new serious risks, signals affecting benefit-risk, or safety issues requiring urgent assessment.