Non-interventional pharmacovigilance studies - an analysis of real-world data sources in the HMA-EMA catalogs

Real-world data catalogs established by the Heads of Medicines Agencies and the European Medicines Agency (HMA–EMA RWD catalogues) represent a centralized digital approach for broad access to reliable data to ensure patient safety. In this study, RWD catalog analysis was conducted in order to identify best practices and challenges, focusing on finalized non-interventional studies (NISs) with a scope specified as ‘safety’. The results (n = 240) show a predominance of studies required by a pharmaceutical regulator (56.6%) as well as the importance of NIS in pharmacovigilance via inclusion in risk management plans (RMPs) (52%) and broad use of NIS in risk minimization measure (RMM) evaluation. However, the lack of a unified regulatory framework, insufficient published data, and the recognized need for digital tool implementation create the necessity for improvement within the European Union (EU) pharmaceutical legislation.