Today, clinical trials are not only a tool for the development of science and medicine, but also an important factor in the economic development of the state, attracting investment and ensuring patients' access to innovative treatment.
The role of clinical trials in the development of the healthcare system and Ukraine's integration into the European research area became one of the key topics of the National Forum "Healthy Ukraine 2030: Strategy, Partnership, European Horizon", which took place on 5 June in Uzhhorod.
The focus of the event is Ukraine's integration into the European area, the development of cross-border medicine, the pharmaceutical sector, medical technologies and digitalization as key tools for improving the efficiency of the healthcare system.
The event was organized by the Ministry of Health of Ukraine and the WHO Office in Ukraine with the support of the European Union and the Belgian international cooperation agency Enabel.
Among the participants are representatives of central executive authorities, international organizations, the pharmaceutical business, medical institutions, educational establishments, patient organizations and the professional community.
Within the thematic block "Clinical trials in Ukraine: potential and development pathways", the management of the State Expert Center of the Ministry of Health of Ukraine presented its vision for the further development of the clinical research sector in Ukraine.
The Director of the Center, Edem Adamanov, emphasized that today countries compete not only for manufacturing or technology, but also for the right to be a site for conducting international clinical trials.
"Our task is to view clinical trials as an element of state policy, and not solely as a regulatory procedure. For Ukraine, this is a matter of patients' access to innovative treatment, the development of medical science, attracting investment and enhancing the competitiveness of the healthcare system," noted Edem Adamanov.
According to him, integration into the European regulatory space is impossible without Ukraine's competitiveness in the field of clinical trials. That is why the consistent harmonization of national legislation with the requirements of the European Union continues, along with the implementation of the provisions of EU Regulation No. 536/2014, the development of digital services and the strengthening of the ethical oversight system.
Today, clinical trials in Ukraine fully comply with the requirements of the updated European GCP ICH standard.
"For us, European integration is not a formal fulfilment of requirements. It is the creation of a clear, transparent and predictable system compatible with European rules," emphasized the Director of the State Expert Center.
Among the steps already implemented:
- reduction of the timelines for regulatory review of clinical trial materials from 45 to 30 days;
- the possibility of conducting clinical trials of all types of medicinal products;
- digitalization of regulatory procedures;
- launch, from 1 April 2026, of the mechanism for submitting electronic applications for clinical trials and substantial amendments through the Single Window of the Ministry of Health.
Particular attention during the discussion was paid to Ukraine's potential as a future European hub for clinical research. Despite the challenges of wartime, Ukraine has preserved highly qualified researchers, a modern clinical base, considerable experience of participation in international multicentre trials and high adaptability of the healthcare system.
Within the thematic block, a panel discussion was also held entitled "How to increase Ukraine's attractiveness for conducting clinical trials and increase their accessibility for patients", moderated by Deputy Director of the State Expert Center for HTA and Clinical Trials Yevheniia Ishkova.
Representatives of the pharmaceutical industry, contract research organizations, the academic community, clinical centers and patient organizations joined the discussion.
The discussion participants emphasized that enhancing Ukraine's attractiveness for international sponsors requires joint efforts of the state, the regulator, medical institutions and business.
The key priorities identified were:
- further digitalization of processes;
- harmonization with EU legislation;
- ensuring predictability of regulatory procedures;
- development of clinical infrastructure;
- improving accessibility of clinical trials for Ukrainian patients.
The forum also included the signing of a Memorandum of Cooperation between the State Expert Center of the Ministry of Health of Ukraine and the Association "Medicine Manufacturers of Ukraine", where the development of the clinical trials sector is one of the key areas of cooperation.
The Memorandum provides for joint work on harmonizing regulatory approaches with EU legislation, enhancing Ukraine's attractiveness for conducting clinical trials, developing modern regulatory practices, adhering to ethical standards and protecting the rights of clinical trial participants.
The forum "Healthy Ukraine 2030" became another platform for professional discussion about the future of clinical trials in Ukraine and confirmed: the development of this field is one of the strategic directions of modernizing the healthcare system, enhancing the country's competitiveness and further integrating Ukraine into the European research area.
