When a new product is approved, safety and efficacy is based on studies from a limited number of patients and patient population, where high risk patients are often excluded. Additionally monitoring is intense, enabling safety data to be collected throughout the development programme. After registration and when marketed the exposure to the product is broader than before with less monitoring, therefore there is a need for regular assessment of the medicinal product with continuous analysis of safety and efficacy. The majority of the new information is safety related but information related to effectiveness, limitations of use and alternative treatments that may be relevant to medicinal products benefit:risk profile.

The PBRER has a modular approach so sections of the document are the same as corresponding sections in other regulatory reports such as the DSUR and safety specification of the RMP, which will help improve efficiency.

The objective of the PBRER is to present a comprehensive, critical analysis of new or emerging information on the risks of the medicinal product and the benefit in the approved indications, which enables an appraisal of the products overall benefit:risk profile. The assessment of the emerging information in the context of cumulative information is performed by:-

  • assessing whether the information in the reporting period is in accord with the previous knowledge of the products benefit:risk profile
  • summarising relevant new safety information that could impact on benefit:risk profile of the medicinal product
  • summarising important new efficacy/effectiveness information available during the reporting period
  • conducting an integrated benefit-risk when important new safety information emerges

The document should provide assurance to the regulatory authorities that the marketing authorisation holder adequately monitors and evaluates the evolving safety profile of their medicinal product.

Essjay solutions can write any part of your PBRERs and comparative benefit:risk analyses that are required as part of the new format. We can also review current processes and advise on operational efficiency regarding the development of the PBRER.