2 March 2012

The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 2 of the ICH Process in February 2012 and now enters the consultation period (Step 3).

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.

This Step 2 document marks the conclusion of the first phase of the E2C(R2) Expert Working Group’s mandate. During the consultation period, the group will initiate the second phase of its mandate which is to conduct a gap and potential improvement analysis of ICH E2C, E2E and E2F Guidelines.

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

You are invited to provide comments on the draft Guideline by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EU, US and Japan are encouraged to submit their comments to their respective Regulatory Authorities.