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This study aims to analyze the reasons behind withdrawn drug applications submitted to the EMA from 2006 to 2024.

Critical analysis of withdrawn drug applications in marketing authorization procedures of the European Medicines Agency (EMA) 2006–2024

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This study aims to analyze the reasons behind withdrawn drug applications submitted to the EMA from 2006 to 2024.
Analyzed all 330 withdrawn drug applications published by the EMA from 2006 to 2024.
Examined parameters including active substances, therapeutic subgroups, and objections raised by the EMA.
Identified the prevalence of key clinical trials and marketing authorization recommendations.
80 withdrawn applications were for antineoplastic agents, the most common therapeutic subgroup.
73.9% of drug applications were for initial approval based on a single key clinical trial.
In 77.3% of cases, key clinical trials included a control arm, and 69.7% had no initial marketing authorization recommendation.

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Critical analysis identifies reasons for withdrawn drug applications in the EMA from 2006 to 2024, suggesting areas for improvement.

Hitsch et al. (2026) studied this question.

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