Analysis of marketing authorizations, withdrawals, and refusals by the European Medicines Agency (EMA): trends in approval procedures 1995-2025.

The European Medicines Agency (EMA) is an institution of the European Union (EU), responsible for the authorization and pharmacovigilance of medicinal products. In our study, we present a systematic analysis of the 1,985 centralized EMA marketing authorization procedures (MAP) between 1995 and 2025. The analysis mainly includes EMA marketing authorizations, withdrawals of marketing authorizations, and revocations of marketing authorizations or refusals of drug applications. With regard to the analysis period, it is evident that the number of marketing authorizations recommended by the EMA increased significantly between 1996 (first fully published evaluation year) and 2025. Among the active substances (International Nonproprietary Names, INNs) in centralized EMA MAPs, clopidogrel and denosumab are the most frequently represented. On the other hand, antineoplastic agents and immunosuppressants are the most common therapeutic subgroups according to the Anatomical Therapeutic Chemical Classification (ATC) in MAPs. Notably, special MAPs for medicines such as generics, biosimilars, and medicines for the treatment of rare diseases (orphan medicines) account for more than 30% of MAPs. Our analysis shows that the development of centralized EMA MAPs is influenced by multiple factors such as medical need, regulatory framework, the economic potential of medicines, and patent law considerations. Our analysis provides a comprehensive overview of these procedures and may help identify potential obstacles and opportunities for their further development.