Across 207 European Phase III cardiology trials, the median CTIS end-to-end review was 100 days (SD 46), while 717 country-level Part II reviews had a median of 70 days (SD 239). Only 36.2% of EU submissions reached first authorisation within 60 days; country, trial scale, sponsor/CRO complexity and submission timing were the clearest correlates of slower review.
The median interval from initial CTIS/EU submission to first authorisation was 100 days across 207 trials. Half were authorised by day 100, while the upper quartile was largely resolved by day 120.
A 60-day planning assumption would cover only 36.2% of submissions. A 120-day allowance captures 84.1%, making it a more realistic operational benchmark for first EU authorisation.
Across 717 member-state reviews, the median country-specific Part II interval was 70 days. The mean was 204 days and SD was 239 days, showing that a substantial long tail sits behind the median.
Part II is more volatile than the end-to-end trial metric. Although 47.1% of country reviews finished within 60 days, one quarter exceeded 385 days; country selection therefore materially changes launch risk.
Median Part II time ranged from 27 days in Croatia to 324 days in Ireland. Germany, Poland and Spain had medians of 55, 58 and 64 days, whereas Italy and France reached 118 and 132 days.
Country medians are operationally useful, but the large SDs show wide within-country variation. Portfolio planning should use both the median and dispersion rather than treating a country median as a guaranteed timeline.
Faster submissions were defined as end-to-end authorisation in under 100 days. Smaller and less geographically complex trials, academic/healthcare sponsorship and July–October submissions were consistently more likely to beat that benchmark.
The strongest practical pattern is cumulative complexity: multi-country, large-site and externally coordinated submissions cluster above the median. These are associations, not evidence that any single characteristic directly causes delay.
The table compares groups with the clearest separation in the probability of taking at least 60 or 90 days. Digital recruitment and CRO presence should be interpreted primarily as markers of operational complexity.
Pharma-sponsored submissions had a 71.6% probability of reaching 90 days versus 42.4% for academic/healthcare sponsors. In a simplified adjusted model, pharma sponsorship remained associated with lower odds of beating the median and higher odds of a 90-day review, while other signals weakened after accounting for scope and size.
Within disease groups with at least 10 trials, arrhythmia had the shortest median at 55 days and only 18.2% reached 90 days. Lipids/ASCVD had the longest median at 114 days, with 78.8% reaching 90 days.
Biologic/RNA trials had a 110-day median and 73.0% reached 90 days, compared with 99.5 days and 55.6% for small molecules. Disease and modality likely capture differences in protocol, safety and operational complexity rather than isolated regulatory effects.
Country remained the dominant Part II correlate, but submission month, adaptive design and local site footprint also separated faster from slower reviews. July Part II submissions had a 456-day median versus 28 days in April.
The July effect and adaptive-design effect are large, but they may reflect cohort composition, amendments or staged country entry. They are useful risk flags for planning and prioritisation, not causal estimates of authority performance.
Key terms used throughout the report.