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Improvement of conditions for clinical trials in Ukraine

29/ 03/ 2023
  The Clinical Trials Subcommittee of the European Business Association (EBA CTS) welcomes the shortening the terms of expertise of documents/materials of clinical trials of medicines (CTs) by the SE State Expert Center of the Ministry of Health of Ukraine (SEC), and the terms of publication of orders by the Ministry of Health (MOH). From now on, the term of expertise for initial clinical trials is no longer than 30 calendar days, and the term for MOH orders approval is shortened to 5 calendar days. Corresponding changes to the Procedure for conducting clinical trials of medicinal products and examination of clinical trial materials were approved by the MOH Order dated January 31, 2023 #190. Business representatives are confident that these changes can speed up the beginning of CTs of domestic and international sponsors, and will generally improve the attractiveness of Ukraine for conducting international clinical trials, especially in the conditions of their significant reduction due to the rf full-scale war against Ukraine. The Associations experts believe that these changes and changes to the legislation, which are being developed, will indeed bring Ukraine closer to the best European and world practices, speed up the path of integration into the European Union, contribute to the return of international sponsors to Ukraine and, thus, the attraction of foreign investments and rapid recovery of the industry after the victory. Thereby, the conditions for conducting clinical trials in Ukraine will reach a qualitatively new level. Improving the conditions for conducting CTs in Ukraine will also make it possible to take over the amount of CTs lost by the rf due to sanctions, which can significantly help to accelerate the release of innovative medicinal products in the world. For a long time, the EBA CTS has been cooperating with the SEC and MOH on creation favorable environment for the better functionality of the clinical trials in Ukraine. With the beginning of a full-scale war, the importance of this cooperation only increased, because the industry is quite vulnerable and sensitive to todays realities. Therefore, it is extremely gratifying to note that as a result of long-term joint work and despite the circumstances, we have managed to achieve these long-awaited changes. The EBA thanks the teams of the MOH, SEC and the experts of the CTS member companies for their fruitful work for the support and development of clinical trials in Ukraine. Improving the conditions for conducting clinical trials is the key to vital progress in this field in Ukraine. We continue to work for Victory!

The Clinical Trials Subcommittee of the European Business Association (EBA CTS) welcomes the shortening the terms of expertise of documents/materials of clinical trials of medicines (CTs) by the SE “State Expert Center of the Ministry of Health of Ukraine” (SEC), and the terms of publication of orders by the Ministry of Health (MOH). From now on, the term of expertise for initial clinical trials is no longer than 30 calendar days, and the term for MOH orders approval is shortened to 5 calendar days. Corresponding changes to the Procedure for conducting clinical trials of medicinal products and examination of clinical trial materials were approved by the MOH Order dated January 31, 2023 #190.

Business representatives are confident that these changes can speed up the beginning of CTs of domestic and international sponsors, and will generally improve the attractiveness of Ukraine for conducting international clinical trials, especially in the conditions of their significant reduction due to the rf full-scale war against Ukraine.

The Association’s experts believe that these changes and changes to the legislation, which are being developed, will indeed bring Ukraine closer to the best European and world practices, speed up the path of integration into the European Union, contribute to the return of international sponsors to Ukraine and, thus, the attraction of foreign investments and rapid recovery of the industry after the victory. Thereby, the conditions for conducting clinical trials in Ukraine will reach a qualitatively new level.

Improving the conditions for conducting CTs in Ukraine will also make it possible to take over the amount of CTs lost by the rf due to sanctions, which can significantly help to accelerate the release of innovative medicinal products in the world.

For a long time, the EBA CTS has been cooperating with the SEC and MOH on creation favorable environment for the better functionality of the clinical trials in Ukraine. With the beginning of a full-scale war, the importance of this cooperation only increased, because the industry is quite vulnerable and sensitive to today’s realities. Therefore, it is extremely gratifying to note that as a result of long-term joint work and despite the circumstances, we have managed to achieve these long-awaited changes.

The EBA thanks the teams of the MOH, SEC and the experts of the CTS member companies for their fruitful work for the support and development of clinical trials in Ukraine. Improving the conditions for conducting clinical trials is the key to vital progress in this field in Ukraine. We continue to work for Victory!

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