The main focus of the Subcommittee\u2019s work for 2025 has been defined as facilitating the recovery of clinical trials in Ukraine and adapting the market to new regulatory conditions, with only a year and a half remaining before their implementation. Specifically, this refers to the enactment of the Law of Ukraine “On Medicinal Products”, which will come into force on January 1, 2027, laying the foundation for European-standard pharmaceutical market regulations, including clinical trials. Importantly, certain requirements requiring a longer adaptation period, such as licensing of investigational medicinal product (IMP) imports and GMP inspections of IMP manufacturing, have been successfully postponed until early 2028.<\/span><\/p>\nWe also anticipate positive developments in the revision of criminal liability provisions related to clinical trials, and we count on parliamentary support during the final vote. We hope the draft law for the second reading will remain aligned with best European practices and will not repeat the flaws of current regulations.<\/p>\n
Creating favorable conditions for attracting new clinical trials to Ukraine is impossible without strong partnerships with government authorities, forming the basis of our collaboration with the Verkhovna Rada, the Ministry of Health, the State Expert Center, the State Service of Ukraine on Medicines and Drugs Control, and others.<\/p>\n
Logistics-related challenges have emerged as a pressing issue, particularly given significant regulatory changes in the context of EU integration, which also impact clinical trial processes. Within the Subcommittee\u2019s Working Group, we will continue seeking solutions to these challenges.<\/p>\n
2025 is expected to be a pivotal year in shaping an updated regulatory landscape for clinical trials in Ukraine. There is substantial work ahead to align national legislation with European norms and establish effective coordination among all industry stakeholders within the new regulatory framework. These objectives must be achieved by the end of 2026 to ensure a smooth transition and full-scale recovery of clinical trials in Ukraine.<\/p>\n
To further strengthen Ukraine\u2019s position in the global clinical research market, we plan to host initiatives for experience-sharing with companies that are still in the process of resuming their operations in Ukraine. Additionally, we aim to explore new communication channels with international pharmaceutical companies to secure Ukraine\u2019s inclusion in clinical trials of innovative medicines.<\/p>\n
Another crucial aspect of comprehensive support for clinical trials is keeping stakeholders informed about the current status, challenges, trends, and achievements in the sector. For this purpose, we have agreed on a structured survey plan for 2025 to collect valuable insights from industry participants.<\/p>\n
With a unified effort between businesses, government agencies, and the professional community, Ukraine has all the potential to become a competitive destination for international clinical research.<\/p>\n
We are grateful <\/span>\u00a0to all CTS <\/span>member companies for their active engagement and valuable expertise in driving forward key initiatives!<\/p>\n<\/p>","protected":false},"excerpt":{"rendered":"
The main focus of the Subcommittee\u2019s work for 2025 has been defined as facilitating the recovery of clinical trials in Ukraine and adapting the market to new regulatory conditions, with only a year and a half remaining before their implementation. Specifically, this refers to the enactment of the Law of Ukraine “On Medicinal Products”, which […]<\/p>\n","protected":false},"author":33544,"featured_media":629863,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n
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The main focus of the Subcommittee\u2019s work for 2025 has been defined as facilitating the recovery of clinical trials in Ukraine and adapting the market to new regulatory conditions, with only a year and a half remaining before their implementation. Specifically, this refers to the enactment of the Law of Ukraine “On Medicinal Products”, which will come into force on January 1, 2027, laying the foundation for European-standard pharmaceutical market regulations, including clinical trials. Importantly, certain requirements requiring a longer adaptation period, such as licensing of investigational medicinal product (IMP) imports and GMP inspections of IMP manufacturing, have been successfully postponed until early 2028.<\/span><\/p>\n