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On January 16, representatives of the Clinical Trials Subcommittee of the European Business Association met with Edem Adamanov, Deputy Minister of Health (MOH), to discuss the functioning of the clinical trials industry (CT) in the current environment, as well as the necessary steps to restore international clinical trials in Ukraine.<\/span><\/p>\n The meeting was held with the participation of representatives of the Pharmaceutical Department and the State Expert Center (SEC) of the Ministry of Health, particularly Oleksandr Hritsenko, Acting Head of the Pharmaceutical Department; Mykhailo Lobas, Deputy Director of the SEC, and Taisa Herasymchuk, Director of the Department of Expertise of Preclinical and Clinical Trial Materials of the SEC. The EBA Clinical Trials Subcommittee (CTS) was represented by CTS Board Head Andrii Biliavskyi, Board Members Serhiy Mykhaylov and Vizgalova, as well as the CTS Executive Director Iryna Magdik.<\/span><\/p>\n An open dialogue was held on important issues of the CTs sphere at the end of the third year of the full-scale war in Ukraine. The participants discussed key markers of the state of clinical trials, the main recovery trends, and influencing factors for CTs industry development in Ukraine.<\/span><\/p>\n The joint efforts of all market participants enabled CTs<\/b> in Ukraine to withstand the challenges and demonstrate positive recovery trends.<\/b><\/p>\n Thus, in 2024, compared to 2023, the <\/span>number of approved CTs increased by 2.2 times<\/b> (68 vs. 31), and the <\/span>number of approved CT sites increased by 2.5 times<\/b> (343 vs. 136). <\/span>207 additional CT sites were approved in 43 active CTs, which is three times more<\/b> than in 2023.<\/span><\/p>\n Together, the Ministry of Health, SEC, the Verkhovna Rada, and experts from the Clinical Trials Subcommittee, even during martial law in the country, managed to improve the regulatory conditions for CTs approval through amendments to laws of Ukraine and MOH Orders in particular to Order No.690 (a total of 6 MOH Orders with amendments), as well as to regulate the requirements for insurance in CTs, patient access program to investigational medicinal products (amendments to the Law \u201cOn Medicines\u201d, MOH Order No.1525, amendments to the Tax Code, etc.).<\/span><\/p>\n During the meeting, special attention was paid to discussing plans for 2025, namely <\/span>the possibility of increasing the number of ongoing clinical trials in Ukraine, at least to the pre-war level of 2022.<\/b><\/p>\n The meeting participants drew attention to problematic points, the resolution of which will contribute to the positive dynamics of the clinical trials development. <\/span>For Ukraine to realize its potential and become a significant European and international partner for clinical trials, joint efforts need to be invested in clinical trials now \u2013 <\/b>first, in further improving the<\/span> legislation to create advantages for Ukraine in the global clinical trials market, especially in the EU.<\/b> In particular, it is necessary to continue bringing the national \u2018Procedure for Conducting Clinical Trials of Medicinal Products and Expertise of Clinical Trial Materials\u2019, approved by Ministry of Health Order No. 690, to European standards. Significant advantages will be accelerating the approval and initiation of clinical trials, implementing modern advanced clinical trial methods, digitalization, and eliminating bureaucracy and other barriers (e.g., regulation of criminal liability, in the long run, tax benefits, etc.).<\/span><\/p>\n It was discussed <\/span>the need to invest efforts in the development of new investigator sites\/investigators, ethics committees, and health care institutions (HCI), raising awareness about clinical trials among HCI managers, and providing information support for clinical trials at the state level, primarily abroad, focused to international sponsors and regulatory authorities<\/b> for the development of CTs in Ukraine<\/b>.<\/span><\/p>\n The main areas of cooperation between the Ministry of Health, State Expert Center and the EBA CT Subcommittee this year are proposed:<\/span><\/p>\n The European Business Association thanks the representatives of the Ministry of Health and the State Expert Center for their contribution to supporting clinical trials and understanding the importance of restoring the CTs industry in Ukraine. We hope that the joint efforts will strengthen the positive recovery trends and grow the number of clinical trials, creating the basis for further development, strengthening the healthcare system and broader access of Ukrainian patients to innovative medicines. <\/span><\/p>\n <\/p>","protected":false},"excerpt":{"rendered":" On January 16, representatives of the Clinical Trials Subcommittee of the European Business Association met with Edem Adamanov, Deputy Minister of Health (MOH), to discuss the functioning of the clinical trials industry (CT) in the current environment, as well as the necessary steps to restore international clinical trials in Ukraine. The meeting was held with […]<\/p>\n","protected":false},"author":33544,"featured_media":615696,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n\n