The Periodic Benefit-Risk Evaluation Report (PBRER) described in this guideline (see link below) is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions. This guideline defines the recommended format and content of a PBRER and provides an outline of points to be considered in its preparation and submission.

 

Effective date: January 2013

 

Posted on the EMA websit eon 11 February 2013