Across 890 European Phase III oncology CTIS/EU submissions, median end-to-end approval time was 64.5 days (SD 42.4). Only 430/890 trials (48.3%) were authorised within 60 days, while 396/890 (44.5%) required at least 90 days. The strongest delay signals were late-year submission, larger country and site footprints, ADC or bispecific-containing protocols, and high planned recruitment intensity; CRO involvement did not independently shorten timelines.
The approval curve is split around the 60-day mark: 177/890 trials (19.9%) were authorised within 30 days and 430/890 (48.3%) within 60 days. By 120 days, 752/890 (84.5%) had received a first CTIS authorisation.
A 60-day planning assumption covered fewer than half of Phase III oncology CTIS submissions. A 120-day operational buffer covered 84.5%, while a 90-day target still left 44.5% of trials beyond target.
Across 4,289 country-level Part II review cycles, the median was 102 days. Only 1,885/4,289 (43.9%) concluded within 60 days and 2,079/4,289 (48.5%) within 90 days, demonstrating a long right tail in national Part II decisions.
Country Part II timing was less predictable than the first EU authorisation. The large SD reflects a mixture of rapid national reviews and very delayed country decisions, so median and threshold probabilities are more decision-useful than the mean.
Country comparisons are reported only for the national CTIS Part II cycle, because end-to-end timing is a trial-level EU submission outcome rather than a country-attributable measure. Among countries with at least 100 recorded Part II cycles, Denmark had the shortest median at 29 days, followed by Sweden at 37 days and Czechia at 56 days. Romania (176 days), France (166), Germany (161), Poland (157), and Portugal (151.5) had the longest medians.
| Country | Part II n | Part II median | Part II SD | ||
|---|---|---|---|---|---|
| Spain | 488 | 122.5 | 268.5 | ||
| France | 488 | 166.0 | 269.4 | ||
| Italy | 424 | 142.0 | 268.2 | ||
| Germany | 405 | 161.0 | 269.3 | ||
| Poland | 347 | 157.0 | 254.5 | ||
| Belgium | 310 | 73.0 | 268.9 | ||
| Netherlands | 264 | 80.5 | 259.0 | ||
| Czechia | 191 | 56.0 | 262.3 | ||
| Austria | 175 | 125.0 | 273.2 | ||
| Greece | 164 | 131.5 | 254.9 | ||
| Hungary | 145 | 121.0 | 254.4 | ||
| Denmark | 137 | 29.0 | 252.7 | ||
| Sweden | 135 | 37.0 | 242.7 | ||
| Romania | 112 | 176.0 | 257.2 | ||
| Portugal | 110 | 151.5 | 269.5 | ||
| Norway | 98 | 30.0 | 256.5 | ||
| Ireland | 80 | 53.5 | 245.2 | ||
| Finland | 67 | 29.0 | 246.7 | ||
| Bulgaria | 54 | 140.5 | 257.2 | ||
| Slovakia | 37 | 35.0 | 254.2 | ||
| Lithuania | 20 | 38.5 | 238.5 | ||
| Croatia | 13 | 25.0 | 217.2 | ||
| Estonia | 11 | 32.0 | 272.3 | ||
| Latvia | 8 | 8 | 68.0 | 318.0 | |
| Slovenia | 5 | 5 | 98.0 | 309.0 | |
| Cyprus | 1 | — | 1 | 17.0 | — |
Country-specific Part II performance varies materially, but the very large SDs show that medians should be interpreted alongside long-tail risk. These results describe national Part II cycles; they do not isolate a country’s contribution to the coordinated Part I assessment or the overall EU submission timeline.
The table compares median timing, the share below the overall 64.5-day median, and the proportions delayed at least 60 or 90 days. Smaller operational footprints and April–October submissions were associated with faster authorisation; late-year timing, 61+ sites, 11+ countries, ADCs, bispecifics, high planned recruitment intensity, and lung/head-and-neck protocols were associated with substantial delay.
| Factor | n | Median days | <64.5 days | ≥60 days | ≥90 days | Signal |
|---|---|---|---|---|---|---|
| Apr–Oct submission | 568 | 48.0 | 56.5% | 46.0% | 38.6% | Faster |
| 2–5 countries | 227 | 49.0 | 56.8% | 46.3% | 41.0% | Faster |
| 11–30 sites | 218 | 47.5 | 56.4% | 45.0% | 39.0% | Faster |
| Nov–Dec submission | 141 | 119.0 | 29.8% | 71.6% | 65.2% | Delayed |
| 61+ sites | 178 | 110.5 | 33.1% | 68.0% | 63.5% | Delayed |
| 11+ countries | 142 | 109.5 | 37.3% | 63.4% | 58.5% | Delayed |
| ADC-containing | 100 | 110.5 | 33.0% | 69.0% | 65.0% | Delayed |
| Bispecific-containing | 65 | 111.0 | 32.3% | 69.2% | 64.6% | Delayed |
| High recruitment intensity (>7.6 participants/month) | 220 | 103.5 | 41.4% | 61.8% | 54.5% | Delayed |
| Lung or head & neck | 165 | 105.0 | 33.3% | 68.5% | 62.4% | Delayed |
After adjustment for authorisation year, submission season, disease, modality, sample size, and design, November–December submission remained associated with 30.0% longer approval time (95% CI 14.9–47.2). Each doubling of site count correlated with 7.0% longer timing (95% CI 2.5–11.7), each doubling of country count with 5.3% longer timing (95% CI 0.6–10.2), ADC inclusion with 15.2% longer timing, and bispecific inclusion with 14.6% longer timing. In the expanded operational model, each doubling of planned monthly recruitment intensity correlated with 15.5% longer end-to-end timing (95% CI 6.7–25.1).
Extended testing covered sponsor and CRO structure, treatment combinations, authorised investigational medicinal product status, endpoint and eligibility burden, recruitment strategy, and the timing of national Part II submission. Two additional adjusted signals were operationally relevant: aggressive planned recruitment and late-year Part II submission.
High planned recruitment intensity and November–December Part II submission are practical planning flags for longer CTIS/EU submission timelines. Digital recruitment should be treated as a marker of programme and dossier complexity rather than a proven cause. CRO involvement, sponsor location, endpoint count and eligibility-count burden did not independently shorten or delay review after adjustment.
Median end-to-end timing rose from 40 days for trials first authorised in 2024 to 112 days in 2025 and 125 days in 2026. The proportion taking at least 90 days increased from 25.2% in 2024 to 86.4% across the 2025–2026 cohort.
Recent Phase III oncology CTIS/EU submissions in this dataset required substantially longer planning assumptions than 2024 submissions. This year effect remained the largest timing correlate after adjustment for protocol and operational characteristics.
End-to-end CTIS approval: calendar days from the initial Clinical Trials Information System submission to the first recorded authorisation. This is a trial-level EU submission measure and is not attributed to each participating country.
Country-specific Part II: calendar days from the earliest recorded national Part II submission to the latest recorded country decision or authorisation.
Substantial delay: at least 60 days or at least 90 days, reported separately.
Planned recruitment intensity: target sample size divided by the planned recruitment-window months.
Digital or remote recruitment: explicit digital or remote patient-recruitment materials identified in the CTIS dossier.
Association: observed statistical correlation in the CTIS dataset; it does not establish that the factor caused the delay.