ICH E2C (R2) Periodic benefit-risk evaluation report - Scientific guideline

This document defines the recommended format and content of a periodic benefit-risk evaluation report (PBRER) and provides an outline of points to be considered in its preparation and submission.

PBRER 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. Read together with ICH guideline E2C (R2) - questions and answers, step 5.

Keywords: Periodic benefit-risk evaluation report (PBRER), active substance, fixed dose combination product, efficacy, benefit-risk, periodicity, international birth date, data lock point, reference safety information, cumulative subject exposure, clinical trials, non-interventional studies, medication errors, non-clinical data, literature, late-breaking information, signal, risk

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2C (R2) on periodic benefit-risk evaluation report - Step 5

Adopted Reference Number: EMA/CHMP/ICH/544553/1998 Legal effective date: 01/01/2013 Summary:

The Periodic Benefit-Risk Evaluation Report (PBRER) described in this guideline 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 guideline defines the recommended format and content of a PBRER and provides an outline of points to be considered in its preparation and submission.

Document history

Draft ICH guideline E2C (R2): Periodic benefit-risk evaluation report (PBRER)

Draft: consultation closed Consultation dates: 16/04/2012 to 21/05/2012 Reference Number: EMA/CHMP/ICH/544553/1998 Summary:

This guideline defines the recommended content and format of a periodic benefit-risk evaluation report (PBRER) and provides an outline of points to be considered in its preparation and submission.