The ICH guidance E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products among the ICH regions. The ICH E2C(R2) guidance introduced new concepts linked to an evolution of the traditional Periodic Safety Update Report (PSUR) from an interval safety report to a cumulative benefit-risk report. It changed the focus from individual case safety reports to aggregate data evaluation. In addition, the broadened scope increased the need for integrating information within the report.


The benefits of harmonizing technical requirements can only be achieved if the guidance is implemented and interpreted in a consistent way across the ICH regions. In November 2012, the ICH Steering Committee endorsed the establishment of an Implementation Working Group (IWG) on E2C(R2) to assist with the implementation of the guidance. The ICH E2C(R2) IWG has prepared this question and answer (Q&A) document to support implementation of the guidance in practice. The Q&A document is intended to facilitate practical implementation of the PBRER, including points to consider in addressing some of the more novel aspects of the new periodic safety report.

Posted on the FDA website on 18 July 2016