EMA July 2026 Statistics: Negative Opinions Already Match 2025’s Full-Year Total

The EMA July 2026 statistics show 52 positive opinions and 22 new active substances recommended for marketing authorisation in the first seven months of the year, alongside nine negative opinions that already match the total recorded across all of 2025. The cumulative year-to-date figures, published on 17 August 2026 by the European Medicines Agency, cover pre-authorisation evaluations, post-authorisation variations and the Agency’s scientific services for human medicines.

Source: EMA monthly statistics report, July 2026 (EMA/532061/2011). 2026 figures are cumulative year-to-date; preceding years are full-year totals.

EMA July 2026 Statistics: Applications and Evaluations

Applicants started 54 marketing-authorisation applications through July 2026, compared with 103 in full-year 2025, 120 in 2024 and 104 in 2023. Because the 2026 figures are cumulative to the end of July, they are not directly comparable with prior full-year totals — annualised, the current run-rate sits broadly in line with recent years. The Agency’s evaluations yielded 52 positive first opinions, down from 102 in full-year 2025 and 113 in 2024, including 22 new active substances, four conditional marketing authorisations and four approvals under exceptional circumstances.

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Biosimilar applications remain a notable but slowing share of the pipeline. Similar biological products accounted for 11 applications started year-to-date, following a peak of 41 in 2024 and 23 in 2025, a trajectory consistent with the broader biosimilar market trends shaping EU competition. Generic applications reached six started, while orphan new products contributed nine started applications. These figures follow a year in which EU medicine authorisations were shaped by a surge in biosimilars and innovative therapies.

Negative Opinions Rise as Evaluations Get Tougher

The most striking signal in the July data is the nine negative opinions recorded year-to-date — already equal to the nine issued across all of 2025 and well above the six in 2024 and four in 2023. A further six applications were withdrawn before a first opinion and one after a first opinion, while three re-examinations were requested. The rising refusal count echoes the stricter evidentiary standards seen in the CHMP’s July 2026 recommendations, where several applications received negative opinions or were withdrawn ahead of opinion.

Post-Authorisation Workload and Scientific Services

Post-authorisation activity continued to dominate the Agency’s workload. Type IA variations led with 2,129 started and 2,254 finalised, followed by Type IB variations at 2,155 started and 2,088 finalised, and Type II variations at 664 started and 749 finalised. Renewals reached 62 started and 58 finalised, with 16 extensions of marketing authorisation started and 18 annual reassessments begun year-to-date.

On scientific services, the EMA issued 11 opinions on companion diagnostics and processed 12 plasma master file certifications in the year to date. Notably, compassionate-use opinions are no longer reported in the statistics table as of July 2026. For context on how these evaluation trends translate into regulatory decisions, see the EMA CHMP meeting highlights and the EMA’s 2024 annual report, which offers the Agency’s own commentary and analysis.

Source: European Medicines Agency, Monthly statistics report: July 2026 — medicinal products for human use (EMA/532061/2011, 17 August 2026).