EMA Approved 104 Human Medicines in 2025

The European Medicines Agency (EMA) announced the publication of its 2025 Annual Report on June 11, 2026,1 revealing a strong year of regulatory output across both human and veterinary medicines—along with significant advances in biosimilar policy, medicines availability, and the integration of artificial intelligence into agency operations. EMA recommended 104 human medicines for marketing authorization in 2025, of which 38 contained a new active substance that had never previously been authorized in the European Union.1

Among the notable human medicine authorizations highlighted in the report were first-in-class and first-in-indication approvals including Rezdiffra, the first authorized treatment for metabolic dysfunction-associated steatohepatitis in the EU; Brinsupri, the first treatment for non-cystic fibrosis bronchiectasis; Teizeild, a first-in-class therapy to delay onset of stage 3 type 1 diabetes; and Waskyra, the first medicine for Wiskott-Aldrich syndrome. Several of these were advanced therapies or gene therapy products, reflecting a continuing shift in the EU's approval mix toward complex biologics and cell and gene therapies.2

Three medicines—Brinsupri, Vimkunya, and Yeytuo—received recommendations following accelerated assessment, a pathway reserved for medicines addressing unmet medical needs that compresses the maximum review timeline from 210 to 150 days. In addition, 8 drugs received conditional marketing authorization, enabling early patient access before all data are received.2

What Were Some of the Developments in Biosimilars, Critical Medicines, and AI?

In April 2025, EMA published a draft reflection paper proposing a tailored clinical approach for biosimilar development.3 The paper suggested that demonstrated structural and functional comparability, combined with pharmacokinetic data, may be sufficient to establish biosimilarity —potentially reducing the requirement for extensive clinical efficacy studies. The agency noted in the report that this shift has already generated an increased volume of biosimilar scientific advice requests, suggesting sponsors are actively exploring the new pathway.2

The report also covers the official launch of the EU Medicines Agencies Network Strategy to 2028, continued maintenance of the Union List of Critical Medicines, and the full operationalization of the European Shortages Monitoring Platform (ESMP) in 2025—all of which have direct implications for manufacturers' supply chain planning and regulatory compliance strategies. The ESMP creates new visibility requirements around stock positions for critical medicines, and manufacturers supplying the EU market should ensure their shortage reporting processes are aligned with the platform's requirements.1

The report also highlights how digitalization and artificial intelligence (AI) have reshaped the agency’s operations in 2025, moving from exploratory phases into practical application. The agency is expected to increase its use of AI-assisted review tools in the coming years, with potential implications for how manufacturers should structure and submit dossiers.

A Milestone Year

The year also marked EMA's 30th anniversary and the 25th anniversary of the EU Orphan Regulation, which has played a central role in facilitating the development and authorization of medicines for rare diseases. Sixteen of the recommended human medicines in 2025 were for rare disease indications.1

“Currently, we are operating in a period of rapid transformation, defined by new ways of working and major legislative changes,” Rui Santos Ivo, chair of the EMA Management Board, stated in the forward of the report.2 “These developments underscore how essential it is for EMA and the network to remain forward looking, agile, efficient, and firmly committed to safeguarding the EU’s high standards for human and animal health while serving all European citizens. They also highlight the need for ever-closer coordination and solidarity across the European medicines regulatory network as we respond to shared pressures on resources, expertise and capacity.”

The full 2025 Annual Report, including detailed statistics and committee highlights, is available on the EMA’s website.

References

1. EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines. Press release. EMA. June 11, 2026. Accessed June 11, 2026. https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines
2. Annual Report 2025. The European Medicines Agency’s contribution to science, medicines and health in 2025. EMA 2026. Accessed June 11, 2026. https://www.ema.europa.eu/en/documents/annual-report/2025-annual-report-european-medicines-agency_en.pdf
3. Reflection paper on a tailored clinical approach in biosimilar development. EMA. March 27, 2026. Accessed June 11, 2026. https://www.ema.europa.eu/en/reflection-paper-tailored-clinical-approach-biosimilar-development