The periodic safety update reports (PSURs) are prepared with an objective to monitor the benefit–risk balance throughout the lifecycle of the medicinal product. This is of vital importance for ensuring effective and safe use of the medicinal products. For this reason, it is imperative that marketing authorization holders (MAHs) understand the different procedures to follow during the single assessment to implement the result within the specified deadlines. Consequently, healthcare professionals (HCPs) and patients may not know about potential safety concerns and risks regarding the use of medicinal products, due to inadequate or late implementation of PSUSA recommendations.
The white paper focuses on the European regulatory framework for the different PSUSA procedures, their assessment, and timeframes for submitting variations for implementing the outcome.