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# New Guidance on Benefit-Risk Evaluation Reports
- URL: https://www.fdaweb.com/new-guidance-on-benefit-risk-evaluation-reports/
- Published: 2016-07-18T12:00:00.000Z
- Updated: 2026-09-14T21:15:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136209

FDA has posted a revised International Council on Harmonization (ICH) [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM299513.pdf?ref=fdaweb.com) entitled “E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)” that defines the recommended format and content of such reports and offers points to be considered in preparing and submitting them. The guidance revises, combines, and replaces two ICH guidances — *E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs* and *Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs.*

A formal evaluation of a drug’s benefit is a new feature of the PBRER, the agency notes, and it is “recognized that a concise discussion of benefit will usually be sufficient, unless the safety or benefit-risk profile has changed significantly during the reporting interval. Thus, the level of detail provided in certain sections of the PBRER (e.g., evaluation of safety and efficacy data, evaluation of safety signals, and benefit-risk evaluation) should be proportional to the medicinal product’s known or emerging important risks and to evidence of emerging important benefits.”

Additionally, FDA has posted a companion [question and answer guidance ](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM511567.pdf?ref=fdaweb.com)entitled “E2C(R2) Periodic Benefit-Risk Evaluation Report: Questions and Answers” to support the PBRER guidance’s implementation. It is intended to facilitate practical implementation of the PBRER, including points to consider in addressing some of the more novel aspects of the new periodic safety report, according to the agency.