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  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 C (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

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

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)

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

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.