Across 157 Phase II gastroenterology trials, the median CTIS/EU submission-to-first-authorization interval was 101 days (SD 42.6). Country-specific CTIS Part II records had a median of 108 days (SD 246.3), with only 51.3% completed within 120 days. Larger EU footprints, inflammatory bowel disease programmes, randomised designs and pharma-sponsored studies were associated with more ≥90-day end-to-end timelines, while modality and protocol criterion counts showed little relationship.
The end-to-end interval—from initial CTIS/EU submission to first authorization—had a median of 101 days across 157 trials. Country-specific Part II—from the earliest recorded Part II submission to the latest recorded country decision or authorization—had a median of 108 days across 495 country-trial records.
The similar medians conceal very different distributions. End-to-end timing was relatively concentrated, whereas Part II had a pronounced long tail; country planning therefore needs both the median and dispersion, not a single European average.
End-to-end CTIS/EU authorization accelerated sharply between 90 and 120 days: 42.0% of trials were authorized by 90 days and 86.0% by 120 days. Country Part II progressed more gradually, reaching 47.5% by 90 days and 51.3% by 120 days.
A 120-day end-to-end planning assumption covered 135 of 157 trials, but the same threshold covered only 254 of 495 country Part II records. Country activation plans need explicit tail-risk buffers.
Norway had the shortest country median at 21.0 days, followed by Ireland at 23.5 days and Estonia at 24.0 days. Finland had the longest median at 398.0 days, followed by Hungary at 280.0 days and Slovakia at 242.0 days. These are recorded Part II intervals, not statutory review limits.
| Country | n | Median | SD |
|---|---|---|---|
| Norway | 12 | 21.0 | 271.6 |
| Ireland | 4 | 23.5 | 260.9 |
| Estonia | 3 | 24.0 | 373.5 |
| Netherlands | 27 | 26.0 | 177.9 |
| Denmark | 18 | 27.5 | 217.9 |
| Latvia | 6 | 34.0 | 335.9 |
| Lithuania | 4 | 37.0 | 315.6 |
| Portugal | 5 | 48.0 | 267.3 |
| Austria | 17 | 52.0 | 262.9 |
| Belgium | 33 | 79.0 | 228.3 |
| Poland | 37 | 93.0 | 247.6 |
| Slovenia | 3 | 104.0 | 127.6 |
| Czechia | 21 | 118.0 | 235.0 |
| Italy | 45 | 131.0 | 260.0 |
| Romania | 21 | 135.0 | 278.7 |
| France | 54 | 136.0 | 250.3 |
| Bulgaria | 15 | 170.0 | 199.7 |
| Spain | 42 | 180.5 | 244.5 |
| Sweden | 10 | 207.0 | 255.3 |
| Greece | 12 | 207.5 | 249.0 |
| Germany | 51 | 210.0 | 242.5 |
| Croatia | 12 | 211.5 | 260.4 |
| Slovakia | 13 | 242.0 | 284.4 |
| Hungary | 23 | 280.0 | 251.7 |
| Finland | 7 | 398.0 | 301.0 |
The country median spread was 377 days—from 21 days in Norway to 398 days in Finland. High SDs in many countries confirm that local Part II performance is variable even within the same jurisdiction.
EU footprint was the clearest continuous correlate of longer end-to-end timing. Number of countries correlated with review duration at Spearman ρ=0.34 (p<0.001); sites showed a weaker positive correlation (ρ=0.20, p=0.012), and planned sample size was also weakly positive (ρ=0.19, p=0.021).
Single-country submissions had an 88-day median and 47.9% ≥90-day rate, versus 115 days and 81.8% for submissions spanning four or more countries. Trials with 31+ sites also had a higher ≥90-day rate than trials with ten or fewer sites: 79.3% versus 50.6%.
Inflammatory bowel disease (IBD) trials had a 112-day median and 77.6% ≥90-day rate, compared with 84 days and 44.4% for GI oncology or treatment-effect trials. Randomised, pharma-sponsored and CRO-supported programmes also had higher unadjusted ≥90-day rates.
CRO-supported trials had a 110-day median and 69.0% ≥90-day rate (40 of 58), versus 91 days and 53.5% (53 of 99) without a recorded CRO.
These are descriptive associations, not causal effects. Pharma sponsorship, CRO use and randomisation commonly co-occur with larger, more complex multinational programmes; the operational footprint is likely an important upstream contributor.
Submission month showed meaningful pooled variation without using year. October submissions had the shortest median at 44.0 days, followed by July at 67.5 days; March had a 108.0-day median and the highest ≥90-day share among months with at least eight trials at 76.9%.
| Month | n | Median days | ≥90 days |
|---|---|---|---|
| January | 8 | 105.5 | 87.5% |
| February | 12 | 97.5 | 58.3% |
| March | 13 | 108.0 | 76.9% |
| April | 14 | 100.0 | 64.3% |
| May | 10 | 102.0 | 70.0% |
| June | 11 | 91.0 | 54.5% |
| July | 18 | 67.5 | 44.4% |
| August | 14 | 109.0 | 64.3% |
| September | 19 | 89.0 | 47.4% |
| October | 16 | 44.0 | 43.8% |
| November | 8 | 103.5 | 62.5% |
| December | 14 | 107.0 | 64.3% |
Month effects were non-monotonic and probably mix workload, holiday and cohort-composition effects. They are useful as planning signals, but weaker than country and footprint variables for operational decisions.
Drug modality medians clustered tightly between 96.0 and 103.5 days. Counts of inclusion criteria, exclusion criteria, primary endpoints and secondary endpoints had near-zero correlations with end-to-end timing (|ρ|≤0.02).
| Modality | n | Median days | ≥90 days |
|---|---|---|---|
| Mixed / other | 25 | 96.0 | 64.0% |
| Antibody + small molecule | 24 | 98.5 | 54.2% |
| Other modality | 11 | 102.0 | 63.6% |
| Monoclonal antibody | 27 | 103.0 | 55.6% |
| Small molecule | 70 | 103.5 | 60.0% |
For Phase II gastroenterology CTIS/EU submissions, operational geography separated timelines more clearly than molecule class or the simple number of protocol criteria and endpoints.
The dataset supports three practical CTIS/EU submission planning bands.