Pharmacovigilance

Periodic Benefit-Risk Evaluation Report(PBRER)

A periodic safety report format harmonized by ICH for presenting comprehensive benefit-risk analysis of medicinal products.

Usage Examples

The annual PBRER was submitted to all marketing authorization holders.
PBRER analysis identified a new safety signal.
Benefit-risk remained favorable based on PBRER data.

What is PBRER?

The Periodic Benefit-Risk Evaluation Report (PBRER) is the ICH-harmonized format for periodic safety reports, replacing region-specific formats like PSURs (EU) in many contexts. PBRERs provide a comprehensive, concise analysis of risk-benefit balance.

PBRERs include worldwide marketing status, regulatory actions, exposure data, adverse reaction summaries, signals, safety-related labeling changes, and overall benefit-risk assessment. The international birth date (IBD) determines reporting periods.

ICH E2C(R2) defines PBRER content and format. Submission frequency varies by region and product maturity, typically ranging from 6 months to 3 years.

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, EU GVP MODULE VII.

FDAEMAWHO

When This Matters

The annual PBRER was submitted to all marketing authorization holders.
PBRER analysis identified a new safety signal.
Benefit-risk remained favorable based on PBRER data.

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 E2CEU GVP MODULE VII

Frequently Asked Questions

PBRER is the ICH-harmonized format; PSUR is the EU-specific term. In the EU, PSUR now follows PBRER format per ICH E2C(R2). Some regions may use different periodic report formats.

Frequency varies by region and product age: typically every 6 months for the first 2 years, annually for years 2-5, then every 3 years thereafter. Risk-based approaches may modify frequency.