Ukraine

Regulatory

The laws of Ukraine contain specific requirements for performing clinical trials. They are in accordance with the principles of Good Clinical Practice (GCP). All clinical trials must be registered by the State Expert Center of the Ministry of Health of Ukraine. Clinical research can only be conducted at the clinical sites authorized by the Ministry of Health based on the positive decision issued by the State Expert Center of MoH. The State Expert Centre is the regulatory authority for preclinical research, clinical trials, and registration of medicines. Ethics approval is obtained at the institutional level.

Official links

https://www.dec.gov.ua/materials/zakonodavstvo-ukra-ni-pro-doklinichni-ta-klinichni-viprobuvannya/

Pharmaceutical Industry & Clinical Trials Market

Ukraine is an attractive region for clinical trials in the central part of Eastern Europe. Today, the Ukrainian pharmaceutical industry is a fast-growing, innovative, and attractive industry for investors. The average annual growth of the national market over the past 5 years has remained at 15–20%. State participates in procurement and reimbursement of drug costs which is one of the drivers of growth in the domestic market.

There are several distinct advantages for conducting clinical trials in Ukraine:

• competitive recruitment due to the large population of patients with no previous therapeutic exposure to modern treatments;
• favorable legal landscape compliant with the European standards;
• lower costs compared with EU countries and the US;
• skilled experienced medical professionals fully trained and compliant with ICH-GCP standards;
• physicians and patients are open to participating in clinical trials as a means of accessing novel treatments;
• over 2,500 of well-equipped public medical facilities with experience in running international trials;
• efficient approval process.

Medical System in Ukraine

National Health Service Ukraine (NHSU) is funded through taxation and guarantees free healthcare. Primary care, palliative care, and emergency medical care are 100% funded by the state. The state provides reimbursement for the cost of medicines for cardiovascular diseases, asthma, and type 2 diabetes.