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A Periodic Benefit Risk Evaluation Report (PBRER) is a format of safety report described by the ICH-E2C(R2) guideline which is used as a basis for the EU Periodic Safety Update Report (PSUR). The report is produced by the marketing authorisation holder (MAH) at defined time points after a medicine has been given marketing authorisation. The motive of the report is to provide comprehensive and up-to-date information about the safety of a medicine. The report needs to summarize any new evidence on safety, efficacy and effectiveness that might affect the balance of risks and benefits. It provides details about the risks to Regulatory authorities and identifies where risk management initiatives may be required.

Objective of a PBRER

The main objective of a PBRER is to present a concise, comprehensive, and critical analysis of new or emerging information on the risks of a medicinal product, and on its benefit towards approved indications, to enable an evaluation of the product’s overall benefit-risk profile. The PBRER should contain an evaluation of new information related to the medicinal product that has become available to the MAH during the reporting interval, in the context of cumulative information by:

  • Outlining relevant new safety information that can have an impact on the benefit risk profile of the medicinal product
  • Outlining any important new efficacy/effectiveness information that has become available during the reporting interval
  • Inspecting whether the information obtained by the MAH during the reporting interval is in accord with previous knowledge of the medicinal product’s benefit and risk profile
  • Understanding where important new safety information has emerged, conducting an integrated benefit risk evaluation for approved indications

Where necessary, the PBRER should include proposed action(s) to optimize the benefit-risk profile. Urgent safety information should be reported through proper mechanism. The PBRER is not intended to be used to provide initial notification of significant new safety information or to provide the source by which new safety concerns are detected. PBRER is necessary for manufacturers to ensure the safety of end-users.

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