20 December 2012

The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 4 of the ICH Process in November 2012 and now enters the implementation period (Step 5).

The purpose of this revised guidance is to ensure 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.

The final Guideline is now available for download under the Efficacy Guideline page.