The European Medicines Agency (EMA) has reported that 45 marketing-authorisation applications for medicinal products for human use were started in the first half of 2026, compared to 103 in the same period of 2025, according to its monthly statistics report for June 2026, published on 9 July 2026. The figures, covering cumulative year-to-date data, show a significant drop across most categories, including new non-orphan products (22 started vs. 37 in 2025), orphan medicinal products (7 vs. 21), and similar biological products (6 vs. 23). Generic applications also fell to 7 from 9. The number of applications finalised in 2026 stood at 46, down from 111 in the full year 2025.
The report, produced by EMA's Human Medicines Division, provides factual data on the volume and evaluation of marketing-authorisation and post-authorisation applications. It does not include commentary or analysis, which is reserved for the Agency's annual reports. The data also cover advanced-therapy medicinal products (ATMPs), with 2 applications started in 2026 (all orphan ATMPs) and 3 finalised (2 non-orphan, 1 orphan). Paediatric-use (PUMA) products saw no applications started and 1 finalised. Well-established use, abridged, hybrid and informed consent products had 1 started and 4 finalised.
The decline in application numbers may reflect a variety of factors, including the maturation of the regulatory pipeline or shifts in industry submission strategies. Stakeholders most impacted include pharmaceutical companies developing new drugs, particularly those seeking orphan designations, as fewer applications could mean reduced access to EU incentives. Patients awaiting new therapies may face longer timelines if the trend continues. National health authorities and payers may see a slower influx of new medicines for assessment. EMA itself may experience a temporary reduction in workload, potentially affecting resource allocation. The report does not provide reasons for the decrease, and it remains to be seen whether the trend will persist in the second half of 2026.