Comparative analysis of innovative medicinal products’ marketing authorizations between EMA and FDA with focus on pharmacovigilance

Pharmacovigilance is one of the elements assessed during the procedure of granting marketing authorization and continues to be monitored throughout the entire life cycle of a medicinal product. The present work provides a comparative analysis of innovative medicinal product marketing authorizations granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), focusing on therapeutic indications and pharmacovigilance requirements. The study examines 15 medicinal products jointly approved by both agencies in 2024, exploring similarities and differences in authorized indications, safety profiles, and risk minimization measures, including risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS). The analysis reveals a high degree of harmonization, but also differences in risk classification, the application of digital tools, and the regulatory documentation requirements. The findings underline the need for ongoing harmonization and the adoption of best practices in pharmacovigilance to support optimal patient safety outcomes.