ICH E2C(R2)PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER)

ICH E2C(R2)PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER)

This document gives guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. The Guideline is intended to ensure that the worldwide safety experience is provided to authorities at defined times after marketing with maximum efficiency and avoiding duplication of effort and that the periodic safety update reports for marketed drugs have the role of being periodic benefit-risk evaluation reports by covering: Safety evaluation, evaluation of all relevant available information accessible to marketing authorisation holders (MAHs) and benefit-risk evaluation.