This guidance defines the recommended format and content of a Periodic Benefit-Risk Evaluation Report (PBRER), and provides an outline of points to be considered in the preparation and submission of the PBRER. The PBRER described in this guidance 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 guidance revises, combines, and replaces two ICH guidances: E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (ICH E2C guidance) and Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (ICH E2C addendum).

Posted on the FDA website on 18 July 2016