Definition

The ICH E2C(R2) format for periodic safety reports that emphasizes benefit-risk evaluation, replacing the previous PSUR format internationally.

Example

PBRER sections include: worldwide marketing status, update on regulatory actions, estimated exposure, safety data summary, signal and risk evaluation, benefit evaluation, and integrated benefit-risk analysis.

Regulatory source

ICH E2C(R2)

Common mistakes

Using old PSUR format when PBRER is required, or not including adequate benefit assessment.

Inspector question

How do you ensure your PBRER meets all ICH E2C(R2) requirements?

Related terms