UKRAINE

Regulatory and Ethical Procedures

Clinical trials in Ukraine are conducted in accordance with the current ICH GCP requirements. Regulations for performing clinical trials of medicines are laid down in the Ukrainian Law on Medicines of 1996 (amended 1997 and 1999). The Ministry of Health is responsible for issuing the approval for performing a clinical trial. Before the start of a clinical trial, an application must be submitted to the State Pharmacological Centre of the Ministry of Health of Ukraine. Documents required include, among others, authorization letter for the investigator, the clinical trial protocol (in Russian / Ukrainian and in English); CRF and Investigator's Brochure (in English); study medication labels (in Ukrainian); GMP certificates and certificate of analyses; patient information and consent form (in Ukrainian and in English if applicable). The Pharmacological Centre passes on the application documents to the Ethics Committee. Ethics Committee appraisal is obligatory. There is one central Ethics Committee (located in Kiev), which meets once a month. This enables multicentre trials to be promptly organised and started. Health Care System Ukraine has a population of about 50 million. There is an extensive network of health care facilities. Physicians are highly trained and experienced. Patient recruitment rates are outstandingly good. Large numbers of patients can be recruited for clinical trials within a short time. The participating patients are highly motivated since medical support within clinical trials is much better than standard health care. The drop-out rate is very low. The Ukrainian health care system is centralised and well organised. It is to a great extent state-owned and financed by state budget. Private medical insurance and private hospitals play only a very small role. There are a relatively large number of physicians (more than 4 doctors per 1000 citizens) and a large number of public hospitals (over 3000) with about 450 000 hospital beds in total. The National Health Service is in the process of being reformed. The role of the general practitioner / family doctor is being strengthened. Local office/staff ECRON LLC 4 Lysenko Str., 01034 Kyiv, Ukraine Email: bd@ecronacunova.com Authorities Ministry of Health State Pharmacological Centre