Following the release of ICH guideline E2C (R2) Step 5 on the Periodic Benefit-Risk Evaluation Report (PBRER) in January 2013 and EU GVP Module VII – Periodic Safety Update Report (Rev 1) in December 2013, Marketing Authorization Holders (MAHs) have been required to submit PBRERs in the majority of territories worldwide in accordance with the aforementioned content and format.

The PBRER is a highly complex and demanding document, and despite the original ICH guideline turning eight years old this year, some requirements continue to be misinterpreted or overlooked. New guidance has since been released to industry and regulators to provide clarity and common understanding. This is evidenced by the release and subsequent updates to the European Medicines Agency’s E2C (R2) Questions and Answers, the FDA Guidance for Industry, and the GVP VII Explanatory Note. All Regulatory Authorities are committed to continuously improve the pharmacovigilance (PV) guidance based on stakeholder feedback and experience. MAHs are equally obliged to adjust and enhance their process in order to fulfill these requirements.

PBRERs – Pitfalls and Misconceptions

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