Ukraine is the largest country entirely within Europe and the 46th largest country in the world, with its capital in Kiev. A population of about 44.5 million makes it the 32nd most populous country in the world. Ukraine is well known for its Black Sea coastline, spectacular nature, soft climate, unrivaled mountains and cities with rich history and special architecture.
Clinical Trials have been conducted in Ukraine since in 1996. Despite being comparatively young in the industry, country has earned strong and reliable reputation within the community and for the last decade is within the well-performing countries in respect to patient enrollment and quality of data coming from the region. It is centralized medical system, which is a distinctive feature of the whole territory of CIS that causes rapid patient enrollment: there is a number of large specialized hospitals, where people from smaller cities come to receive the comprehensive and advanced treatment from renowned medical professionals and to access the cutting-edge medications and equipment. Experienced investigators and sub investigators are willing to establish trusting relationships with clinical trial participants, thus providing high compliance and retention. Nevertheless throughout 20 years hundred thousands of patients took part in the local and international studies in wide range of therapeutic areas, the foregoing potential is still enormous. In the rapidly progressing climate of drug development industry, number of breakthroughs and constant improvement of treatment practices, for many patients in Eastern Europe participation in clinical trials is a great and sometimes the only way to afford and access the original drugs and generics already available to the same patients in Western Europe and North America.
Ukrainian regulatory authorities meet increasing interest by aligning the legislation for conducting clinical studies to the international standards. Over the past 10 years a streamlined multi-level system of interaction between all organizations involved in clinical trials was formed on the principles of the ICH-GCP. On December 31, 2015 the newest changes to the Ministry of Health’s Order No. 690, establishing the Procedure for Conducting Clinical Trials of Medicinal Products (the Procedure), have become effective. This is considered to be one of the most important events in the field of clinical trials in the country for the several years. The government has shown in practice the strong support directed towards the alignment of internal procedures to the European ones by simplifying import procedures and dramatically reducing duty charges for trial drugs. It is no longer required to obtain an umbrella license before study initiation, and no import permit required for every batch of drugs shipped. While other paperwork remains the same, importation of the IMP and CTMs can begin once there is an approval from Ukraine’s Ministry of Health received to conduct a clinical trial.
Another significant improvement new legislation brings is that all clinical trials should be introduced into the list of clinical trials (the “List”) before the inclusion of the first patient. MoH will publish such list on its official website for information purposes; it was discussed by all major groups of the industry that it is necessary to have a centralized register of Clinical Trials conducted in the country.
Above all, political turbulence has not interrupted clinical trials in Ukraine, where 1204 clinical trials are currently recruiting patients. With that being said, it is advised to avoid some territories.
