The European Medicines Agency (EMA) started 37 marketing-authorisation applications for human medicinal products in the first five months of 2026, according to its monthly statistics report for May 2026 published on 17 June 2026. The figure is down from 103 applications started in the same period of 2025 and 120 in 2024. The report, covering cumulative year-to-date data, shows that 28 applications were finalised by May 2026, compared to 111 in the full year 2025 and 119 in 2024.
The breakdown for 2026 includes 18 new non-orphan medicinal products, 7 new orphan medicinal products, 4 similar biological products, 5 generics and hybrid products, and 2 advanced-therapy medicinal products (ATMPs). No paediatric-use (PUMA) applications were started in 2026. The report also notes that finalised applications exclude those withdrawn prior to opinion. The data is provided for factual information, with analysis reserved for the Agency's annual reports.
The decline in applications started in 2026 compared to previous years may reflect a slower start or changes in industry submission patterns. The report does not provide commentary on the reasons behind the figures. Stakeholders, including pharmaceutical companies and patients, may monitor these trends as indicators of the pipeline of new medicines entering the EU market. The EMA's Human Medicines Division compiles the statistics monthly, and the Agency continues to process applications under its centralised marketing authorisation procedure.
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