Across 33 Phase III gene therapy trials submitted through the European Union Clinical Trials Information System (CTIS), the median end-to-end review was 108 days with a 55.1-day standard deviation (SD). Country-specific CTIS Part II decisions had a 100-day median and a much wider 224.4-day SD. Only 27.3% of trials were authorised within 30 days, while Q4 submissions, programmes with 16 or more EU sites, and trials planning at least 151 participants were most consistently associated with 90-day-or-longer reviews.
The trial-level end-to-end timeline—from initial CTIS submission to first EU authorisation—had a median of 108 days and SD of 55.1 days. Country-level CTIS Part II review, calculated separately for each Member State decision, had a median of 100 days and SD of 224.4 days.
The similar medians conceal very different variability: trial-level authorisation clustered within a narrower window, while Member State Part II timelines had a pronounced long tail. Planning should therefore use country-specific dispersion rather than applying the overall 108-day benchmark to individual countries.
Only 9 of 33 trials (27.3%) received first EU authorisation within 30 days. The cumulative share rose to 15 of 33 (45.5%) by 60 days, 16 of 33 (48.5%) by 90 days, 22 of 33 (66.7%) by 120 days, and 30 of 33 (90.9%) by 150 days.
The 108-day median sits beyond the three-month mark: 17 of 33 trials (51.5%) required at least 90 days, and 11 of 33 (33.3%) required at least 120 days. A 150-day planning allowance captured 90.9% of observed first-authorisation timelines.
Among countries with at least three observed decisions, Greece had the lowest median CTIS Part II timeline at 36 days, followed by Czechia at 55 days and Hungary at 61 days. Bulgaria had the highest median at 224 days, followed by Denmark at 187 days and Spain at 180 days.
| Country | Decisions | Median days | SD days |
|---|---|---|---|
| Finland | 1 | 23.0 | — |
| Greece | 5 | 36.0 | 37.7 |
| Sweden | 2 | 38.5 | 17.7 |
| Czechia | 3 | 55.0 | 74.8 |
| Slovakia | 1 | 61.0 | — |
| Hungary | 3 | 61.0 | 121.7 |
| Portugal | 3 | 74.0 | 102.7 |
| France | 18 | 77.0 | 198.0 |
| Croatia | 1 | 82.0 | — |
| Netherlands | 6 | 91.5 | 284.3 |
| Poland | 5 | 115.0 | 104.4 |
| Germany | 16 | 115.0 | 266.5 |
| Italy | 20 | 150.0 | 247.5 |
| Austria | 2 | 163.0 | 132.9 |
| Belgium | 8 | 165.5 | 305.9 |
| Spain | 21 | 180.0 | 261.0 |
| Denmark | 4 | 187.0 | 117.2 |
| Latvia | 1 | 217.0 | — |
| Lithuania | 1 | 221.0 | — |
| Bulgaria | 3 | 224.0 | 157.1 |
The most decision-rich countries also showed substantial dispersion: France recorded a 77-day median with 198.0-day SD across 18 decisions, Germany 115 days with 266.5-day SD across 16, Italy 150 days with 247.5-day SD across 20, and Spain 180 days with 261.0-day SD across 21.
Across country-level CTIS Part II decisions, 25 of 124 (20.2%) finished within 30 days, 50 of 124 (40.3%) within 60 days, 59 of 124 (47.6%) within 90 days, and 64 of 124 (51.6%) within 120 days.
Country Part II showed a heavier tail than the trial-level process: even at 180 days, only 75 of 124 decisions (60.5%) had completed, and 99 of 124 (79.8%) completed within one year.
Faster-than-median authorisation was defined as under 108 days. Substantial delay was assessed at 60 days or longer and at least 90 days. The strongest descriptive signals were submission timing, EU site footprint, planned sample size, randomisation, population type, orphan status, and therapeutic area.
| Factor contrast | Median days | Faster than 108 | 60+ days | 90+ days |
|---|---|---|---|---|
Submission timing Q4 submissions vs Other quarters |
129.0 vs 41.5 | 11.1% vs 62.5% | 88.9% vs 41.7% | 88.9% vs 37.5% |
Country footprint 6+ countries vs 1–2 countries |
117.5 vs 38.5 | 37.5% vs 66.7% | 62.5% vs 41.7% | 62.5% vs 33.3% |
Site footprint 16+ EU sites vs Fewer than 16 sites |
128.5 vs 42.0 | 0.0% vs 59.3% | 100.0% vs 44.4% | 100.0% vs 40.7% |
Planned sample 151+ participants vs Fewer than 151 |
124.0 vs 41.5 | 11.1% vs 62.5% | 88.9% vs 41.7% | 88.9% vs 37.5% |
Trial design Randomised vs Non-randomised |
123.5 vs 42.0 | 25.0% vs 61.9% | 75.0% vs 42.9% | 75.0% vs 38.1% |
Population Non-paediatric vs Paediatric |
119.0 vs 42.0 | 25.0% vs 61.9% | 75.0% vs 42.9% | 75.0% vs 38.1% |
Designation Non-orphan vs Orphan |
112.0 vs 38.5 | 27.3% vs 59.1% | 72.7% vs 45.5% | 72.7% vs 40.9% |
Therapeutic area Oncology vs Non-oncology |
112.0 vs 45.0 | 0.0% vs 57.1% | 100.0% vs 46.4% | 100.0% vs 42.9% |
Modality mix Multi-modality regimen vs Gene therapy only |
109.0 vs 81.0 | 44.4% vs 53.3% | 55.6% vs 53.3% | 55.6% vs 46.7% |
Operational scale was the clearest delay signal. Every trial with 16 or more EU sites required at least 90 days, compared with 40.7% of trials with fewer sites. Similarly, 88.9% of trials planning at least 151 participants and 88.9% of Q4 submissions required at least 90 days. Smaller, non-randomised, paediatric, and orphan-designated programmes more often completed below the 108-day median.