Resource Library

In 2025, 33 of the 46 novel drugs approved by the FDA (72%) were tested at clinical trial sites in Central and Eastern Europe (CEE). Industry Pages™ 2025 is OCT Clinical's free annual report for sponsors and biotech teams planning trials in the region. It brings enrollment benchmarks, regulatory timelines and country-level data from public sources into one 60-page guide. All data is current as of April 2026.

Key findings

• 72% of FDA novel drugs approved in 2025 (33 of 46) included CEE trial sites; Germany took part in 29 and Poland in 27.
• 71% of EMA new active substances with a positive opinion in 2025 (27 of 38) were tested in CEE.
• Up to 50% lower trial costs than the US and up to 40% lower than Western and Northern Europe; cost per patient is about 28% lower than in Western Europe.
• Faster enrollment: in OCT Clinical Phase III studies, Poland enrolled 3.9 patients/site/month in erectile dysfunction vs 2.1 in Sweden; Ukraine enrolled 1.4 in breast cancer vs 0.5 in the USA.
• CTA approval in 60–120 days across the region, with Georgia and Ukraine at the fast end (60–90 days).
• Strong FDA inspection record: Georgia's 25 FDA inspections were all classified NAI (No Action Indicated).

What's inside

1. Why CEE is a preferred region for global clinical trials
2. Patient enrollment rates by country and indication
3. FDA and EMA 2025 approvals tested in CEE, with drug-by-drug tables
4. Regulatory update: CTA timelines, EU CTIS changes, ICH E6(R3) GCP side-by-side with R2
5. Country profiles: Germany, Poland, Czech Republic, Hungary, Romania, Bulgaria, Ukraine, Serbia, Lithuania, Estonia, Latvia, Georgia, Bosnia and Herzegovina, North Macedonia

Who it's for

Clinical operations, feasibility and outsourcing leads at pharma and biotech companies choosing countries for Phase II–III trials, or looking to rescue a study that is behind on enrollment.

Download the free report (PDF, 60 pages)

Frequently asked questions

Why run clinical trials in Central and Eastern Europe? 

CEE offers large, often treatment-naive patient populations, lower trial saturation and costs up to 50% below the US. Its data is accepted by the FDA and EMA: 72% of 2025 FDA novel drugs included CEE sites.

How long does clinical trial approval take in CEE? 

CTA approval typically takes 60–120 days. Georgia and Ukraine are fastest at 60–90 days; Germany, Poland, the Czech Republic, Hungary, Romania, Bulgaria, Serbia and Latvia take 60–120 days.

Which CEE countries run the most clinical trials? 

Germany (27,607 trials since records began on ClinicalTrials.gov) and Poland (10,946) lead, followed by the Czech Republic (6,714) and Hungary (5,661).

What changed with ICH E6(R3)? 

The guideline, finalized in January 2025, cuts GCP principles from 13 to 11, adds risk proportionality, and formally supports decentralized elements, eConsent and real-world data.

Is the report free? 

Yes. Industry Pages™ is a free annual report by OCT Clinical.