Regulatory Intelligence Tool
Regulatory Timeline Calculator
Estimate best-case, typical, and worst-case timelines for clinical trial authorization and drug development across the US, EU, UK, and China — based on current published regulatory review targets.
1. Choose scope
Clinical Trial Authorization only
From dossier submission to green light to start the trial (IND / CTA)
From dossier submission to green light to start the trial (IND / CTA)
Full development to market
Phase I – III + dossier preparation + marketing authorization review
Phase I – III + dossier preparation + marketing authorization review
2. Choose regions to compare
United States (FDA)
European Union (EMA)
United Kingdom (MHRA)
China (NMPA)
Best case
Typical case
Worst case
Typical case
Worst case
Side-by-side comparison (days)
| Region | Best case | Typical case | Worst case |
|---|
These figures are directional estimates. Every program has its own risk profile — talk to our team for a timeline assessment tailored to your product and target markets.
Methodology & sources
- US – FDA: IND review clock is 30 calendar days (21 CFR 312.40); worst case reflects clinical hold resolution. NDA/BLA review: PDUFA VII standard goal 10 months, priority review 6 months; worst case reflects a Complete Response Letter cycle. Source: fda.gov (IND Applications for Clinical Investigations; Priority Review).
- EU – EMA/CTIS: Clinical Trial Regulation (EU) 536/2014 assessment: up to 50 days with no Request for Information (RFI), up to 81 days with one RFI round, plus up to 15 days for validation issues (worst case). Marketing authorization (centralised procedure): 210 active assessment days (excluding clock stops), reducible to 150 days under accelerated assessment; total time to European Commission decision typically 12–18 months. Source: ema.europa.eu (CTIS Sponsor Handbook; centralised procedure).
- UK – MHRA/HRA: Combined Review under the reformed Clinical Trials Regulations (in force 28 April 2026): Notifiable Trials auto-approved in 14 days; standard combined review target 30 days from validation (7-day validation window), current average 41 days. Marketing authorization: International Recognition Procedure Recognition A = 60 days, Recognition B = 110 days; national procedure for innovative medicines = 150 days, established medicines = 210 days. Source: gov.uk, hra.nhs.uk.
- China – NMPA/CDE: IND review: 30 working-day fast-track pathway for eligible innovative drugs (2025 reform), standard 60 working-day implied-license pathway. NDA review: priority review clock 130 working days; standard review 12–18 months. Working days converted to approximate calendar days (×1.4) for comparison purposes. Source: english.nmpa.gov.cn, CDE announcements.
- Clinical phase durations (Full development scope): Industry-average ranges commonly cited across Phase I–III trials (Tufts CSDD / industry benchmarking data); actual duration varies significantly by therapeutic area, trial design, and recruitment complexity. Treat these as planning ranges, not guarantees.