Retrospective Overview of the Requirements for Aggregate Reports in Pharmacovigilance

This article is an overview of the process of aggregate reporting in pharmacovigilance where the main characteristics of PSUR are presented. 2012 is a crucial moment of the safety reporting when some changes were made and which reflect the main point of the evaluation of the reports-from detailed line-listings of the adverse drug reactions to the cumulative summaries of the serious adverse events, mainly in clinical trials, and the main approach, which is the evaluation of the risk/benefit balance. This leads to discovering new indications of the drugs and a proposal for changes in Summary of Product Characteristics of the observed medications.