What does this research mean for the field?

Centralized EMA marketing authorizations have increased significantly between 1996 and 2025, with antineoplastic agents, immunosuppressants, and special procedures for generics, biosimilars, and orphan medicines accounting for a substantial portion of the approvals. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

Characterize trends and outcomes across centralized European Medicines Agency marketing authorization procedures over a 30-year period.

September 8, 2026Naunyn-Schmiedeberg s Archives of PharmacologyOpen Access

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

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Characterize trends and outcomes across centralized European Medicines Agency marketing authorization procedures over a 30-year period.
Systematic evaluation of 1,985 centralized marketing authorization procedures conducted by the European Medicines Agency between 1995 and 2025.
Tracked authorization recommendations, application refusals, revocations, and withdrawals classified by active substance and Anatomical Therapeutic Chemical subgroups.
Marketing authorization recommendations increased significantly between 1996 and 2025, with clopidogrel and denosumab identified as the most frequent individual active substances.
Antineoplastic agents and immunosuppressants comprised the most common therapeutic subgroups across evaluated procedures.
Special authorization pathways for generic drugs, biosimilars, and orphan medicines for rare diseases accounted for more than 30% of all procedures.

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Implication

Systematic analysis reveals rising European drug approvals with cancer therapies dominating regulatory procedures, highlighting shifting pharmaceutical priorities.

Cite This Study

Hitsch et al. (2026) studied this question.

synapsesocial.com/papers/6a9fd7c658e84d0ff5b46b4c https://doi.org/10.1007/s00210-026-05887-5

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Implication

Systematic analysis reveals rising European drug approvals with cancer therapies dominating regulatory procedures, highlighting shifting pharmaceutical priorities.

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

Key Points

Discussion

Implication

Cite This Study

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

Key Points

Discussion

Implication

Cite This Study

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