Ukraine has a variety of advantages for clinical trial conduct:
- Full compliance to the international standards of ICH GCP (Good Clinical Practice).
- Local legislation in the sphere of clinical research is synchronized with the European one.
- Analysis of the regulatory inspections results, which were conducted by the regulators of EU and USA, demonstrate that Ukraine is second only to Russia for the minimal critical findings in clinical research. In the period from 1995 to 2017 62% of clinical studies in Ukraine had no objections of the FDA. This statistic is based on the ratio between NAI (No Action Indicated)1 and the amount of FDA inspections2.
- The regulatory approval time is up to 50 days.
- The registration procedure takes up to 210 days from the time of acceptance of the application to the issue of registration certificate.
- Ukraine is located in Eastern Europe.
- Big population. As of January 1, 2018, population of Ukraine was 42 233 390 people.
- Medical insurance system is underdeveloped (less than 3% of population uses healthcare insurance).
- Average income per person is 5 times lower than in the EU. In addition, budget spending on healthcare is insufficient, doctors’ salaries are amongst the lowest in the country. It motivates the population to search for additional sources of income, including participation in clinical trials.
- For the vast majority of patients, clinical trials are the only way to receive necessary qualified screening, free treatment with the innovative medicines, and permanent medical control. It facilitates fast enrollment and reduces the drop out level.
- There are many private laboratories and diagnostic centers with advanced equipment.