Comparison of drug approvals of the FDA and EMA between 2013 and 2023.

To what extent do drug approvals differ between Europe (EMA) and the USA (FDA) differ, and how do these differences arise? The study examines differences in approval timelines, therapeutic areas, mechanisms of action, and the marketing authorisation holders for the period between 2013 and 2023. All medicines containing a new active substance (NAS) from the European Medicines Agency's (EMA) Annual Reports, as well as all new molecular entities (NMEs) from the US Food and Drug Administration's (FDA) New Drug Therapy Approvals Reports and the annual Biological Approvals were assessed. The FDA authorised significantly more novel drugs (583) than the EMA (424) during the analysed period. The FDA granted far more exclusive drug approvals (185) than the EMA (42). Both agencies prioritise the therapeutic areas oncology, infectious diseases, haematology, and neurology. Enzyme inhibitors and antibodies are the most common drug classes. Pfizer, Novartis, and AstraZeneca are the Top-3 marketing authorisation holders (MAHs) for the FDA and EMA. The overall US share of EMA approvals exceeds the EU share of FDA approvals. The FDA also tends to use faster and more flexible approval pathways and shows greater tolerance for uncertainty in benefit-risk assessments. It also relies more frequently on surrogate endpoints and limited clinical data, particularly in accelerated approval pathways. In contrast, the EMA shows a stronger focus on long-term safety and public health priorities. Minor timing differences were observed, with the FDA generally authorising drugs earlier. These differences reflect not only company strategies and geographic patterns but also divergent regulatory processes due to different financial frameworks. The FDA also works with a broader range of MAHs overall, suggesting a more diverse and globally active company base. It also approves a wider variety of drugs, including more drugs with unknown mechanism of action. Various international initiatives aim to harmonise regulatory approaches and promote collaboration between agencies. Despite these efforts, differences remain, especially in response to urgent public health challenges. The FDA takes a more exploratory approach to drug approvals, whereas the EMA is more public health oriented. Differences in financial framework, decision-making processes, therapeutic priorities, geographical factors, and strategic marketing decisions of drug companies all contribute to the differences observed in this study. Efforts are in progress to globally harmonise drug approval processes.