ICH E2C (R2) Periodic benefit-risk evaluation report

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Current effective version

Revision 2 - Adopted guideline

Reference numberCHMP/ICH/544553/1998
Effective from01/01/2013
KeywordsPeriodic 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
DescriptionThis 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 questions and answers.

Document history

Revision 2 

Current version

Adopted guideline

Draft guideline

In operation: 01/01/2013–present

Published: 16/04/2012

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