ABSTRACT
The most straightforward answer is that it is a regulatory requirement now that the European Medicines Agency (EMA) has released Module VII of the EMA Guidelines on Good Pharmacovigilance Practices (GVP),1 which explicitly requires inclusion of an integrated B-R assessment in periodic safety update reports (PSURs). Prior to this guidance, companies were required to submit a formal assessment of each identified and potential risk as part of their risk management plan for each product, as well as a PSUR. Both of these documents focused primarily on risks. However, even without this regulatory requirement, it has already become a practice for selected products for some companies to examine a product’s B-R assessment post-launch. Such assessments can provide a strategic product advantage, particularly for any product that may face public comparisons with other products when the market landscape changes following initial product approval, or when important new safety signals emerge unexpectedly.
