Periodic Benefit-Risk Evaluation Report: A European Union Regulatory Perspective
Abstract
New European Union (EU) pharmacovigilance legislation, effective from July 2012, introduced new concepts and procedures to optimise the way medicines are regulated within the Union and provided new channels for public health interventions. Triggered by the EU legislation, the work done by the International Conference on Harmonisation (ICH) has provided a common standard for periodic benefit-risk evaluation reporting within the ICH regions. The present paper provides a review of the concepts behind the use of periodic benefit-risk evaluation reports (PBRER) in supporting safety evaluation and assessment of benefit-risk balance and covers essential points in the documentation of safety information, risk evaluation and benefit-risk assessment. The review incorporates the experience to-date with the PBRER at EU level led by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency. The scope of the PBRER, the main content topics and the challenges relevant to the different stakeholders are highlighted together with key success factors for the report to deliver its objectives and maximise the use of the regulatory assessment procedure. It is clear that the PBRER extends beyond new ways of data presentation and analysis and reflects a further shift in pharmacovigilance in the EU towards more integrated benefit-risk assessment of marketed medicines.
Keywords
European Union Medicinal Product Marketing Authorisation European Union Legislation Periodic Safety Update ReportNotes
Acknowledgments
The authors appreciate the contribution made by Geraldine Portier.
No funding has been received for the preparation of this paper.
Conflict of interest
Peter Arlett, Rodrigo Postigo, Heidi Janssen and Almath Spooner are currently employed by medicines regulatory agencies (European Medicines Agency and Health Products Regulatory Authority) and have been involved in the development of guidelines in relation to the PBRER.
Disclaimer
The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.
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