In the past year, the Ministry of Health (MoH) in Ukraine has demonstrated significant efforts to streamline the approval process for clinical trials, navigating through a challenging political landscape. These efforts have resulted in accelerated study start-up and recruitment processes.
Notably, the MoH of Ukraine announced the release of the latest edition of the Guidelines on “Medicinal Products: General Principles of Preclinical and Clinical Research for Biological Medicinal Products Obtained via Biotechnology” in January 2023. These updated guidelines offer valuable insights and direction for conducting research involving biological medicinal products derived from biotechnology—a pivotal and rapidly evolving field in modern medicine. Adherence to these guidelines is crucial for ensuring the safety, efficacy, and quality of the medicinal products under study.
“In light of the recent regulatory changes in Ukraine, Dmytro Mnozhynskyy, General Director of GCT’s Ukrainian office, expressed his optimism, stating, ‘The proactive steps taken by the Ministry of Health underscore a positive shift in the regulatory environment. These changes not only streamline the approval process but also enhance transparency. GCT remains committed to adapting swiftly to these advancements, and we anticipate further collaborative efforts to foster an environment conducive to cutting-edge clinical research in Ukraine.'”
At GCT, our responsibility extends to staying abreast of the most recent regulations and guidelines, thereby upholding the highest standards in our research processes. This latest edition of the Guidelines aligns seamlessly with our unwavering commitment to excellence, reflecting our dedication to conducting preclinical and clinical research in compliance with the latest industry standards.
Additionally, Ukraine implemented two significant changes in the Ministry of Health Order № 690 of 23 Sep 2009 – Order 190 of 31 Jan 2023 and Order 1034 of 07 Jun 2023. Thanks to these changes, the approval process has been expedited, resulting in a two-fold reduction, and the Clinical Trial Application (CTA) review process has become notably more transparent. Another review is anticipated later this year, promising additional improvements to the regulatory landscape.