Abstract
The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.
Highlights
The evolution of the requirements for assessing the benefits and risks of medicinal products has resulted in changes in the regulatory review process
Where there was a summary in the reference agency format, this would be directly compared with the BR Summary Template and the findings are tabulated and presented
Part III—Case study of US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA) summary reports on ziv-aflibercept (Zaltrap®; Regeneron Pharmaceuticals, Inc./Sanofi-Aventis U.S LLC, Bridgewater, NJ, USA)
Summary
The evolution of the requirements for assessing the benefits and risks of medicinal products has resulted in changes in the regulatory review process. Their initiatives have included the development of a framework to characterize and provide a structure for the benefit-risk assessment already existing in their decision-making processes, as well as communicating the reasoning behind the decision to all stakeholders (US Food and Drug Administration, 2012), which has led to the current FDA five-step benefit-risk framework These steps are related to the five key areas to be discussed in the assessment of a medicine, namely the analysis of the condition, the medical need for the product, clinical benefits, risks and risk management. Mullin, commented that this structured framework has the potential to improve the predictability and consistency of decision-making as it is capable of clearly outlining both the available evidence and the uncertainties (Centre for Innovation in Regulatory Science, 2011). Application of the BR Summary Template to the US FDA Benefit-Risk Assessment provided a more structured and guided discussion of the decisions leading to the eventual benefit-risk balance
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