{"id":718116,"date":"2026-02-10T12:37:17","date_gmt":"2026-02-10T10:37:17","guid":{"rendered":"https:\/\/eba.com.ua\/?p=718116"},"modified":"2026-03-12T17:26:46","modified_gmt":"2026-03-12T15:26:46","slug":"zustrich-pravlinnya-pidkomitetu-klinichnyh-doslidzhen-eva-z-dyrektorom-dets-moz-ukrayiny","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/zustrich-pravlinnya-pidkomitetu-klinichnyh-doslidzhen-eva-z-dyrektorom-dets-moz-ukrayiny\/","title":{"rendered":"[:ua]\u0417\u0443\u0441\u0442\u0440\u0456\u0447 \u041f\u0440\u0430\u0432\u043b\u0456\u043d\u043d\u044f \u041f\u0456\u0434\u043a\u043e\u043c\u0456\u0442\u0435\u0442\u0443 \u041a\u0414 \u0437 \u0434\u0438\u0440\u0435\u043a\u0442\u043e\u0440\u043e\u043c \u0414\u0415\u0426 \u041c\u041e\u0417 \u0423\u043a\u0440\u0430\u0457\u043d\u0438[:en]Meeting of the EBA Clinical Trials Subcommittee Board with the Director of the State Expert Centre of the Ministry of Health of Ukraine[:]"},"content":{"rendered":"<p><\/p>\n<p data-start=\"141\" data-end=\"448\">On 10 February 2026, the Board of the Clinical Trials Subcommittee of the <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">European Business Association<\/span><\/span> held a working meeting with the newly appointed Director of the State Expert Centre of the Ministry of Health of Ukraine, <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">Edem Adamanov<\/span><\/span>, and representatives of the Centre.<\/p>\n<p data-start=\"450\" data-end=\"631\">The meeting was attended by the Head of the Clinical Trials Subcommittee, Andrii Biliavskyi, Board Member Serhii Mykhailov, and Executive Director of the Subcommittee, Iryna Magdik.<\/p>\n<p data-start=\"633\" data-end=\"1058\">The main topic of discussion was the initiative of the Ministry of Health to introduce amendments to the Procedure for Conducting Clinical Trials. In particular, the draft order provides for a significant reduction in the list of institutions that can conduct clinical trials, allowing them to be carried out exclusively by university clinics and clinical bases of educational institutions in the field of healthcare.<\/p>\n<p data-start=\"1060\" data-end=\"1687\">Representatives of the Association emphasised that the proposed changes not only contradict European approaches and the principles of ICH GCP, but also pose significant risks to the industry. In particular, the introduction of administrative restrictions may lead to a reduction in the number of trials, complications and delays in patient recruitment, decreased investment attractiveness, and the effective loss of Ukraine\u2019s competitiveness (as previously highlighted by the Association in its <a href=\"https:\/\/eba.com.ua\/en\/ukrayina-ryzykuye-vtratyty-do-75-rynku-klinichnyh-doslidzhen-u-razi-zaprovadzhennya-zmin-do-poryadku-provedennya-klinichnyh-doslidzhen\/\">earlier position<\/a>). There is also a risk of reduced patient access to innovative treatment methods available through clinical trials.<\/p>\n<p data-start=\"1689\" data-end=\"2188\">The Association\u2019s position is that a centre\u2019s capacity to conduct trials should be determined by its compliance with ICH GCP requirements, namely by functional capacity criteria \u2014 including a quality management system, appropriate infrastructure, qualified personnel, relevant research experience, etc. \u2014 rather than by its formal institutional status. This approach aligns with European standards and the requirements of <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">Regulation (EU) No 536\/2014<\/span><\/span> on equal and non-discriminatory access.<\/p>\n<p data-start=\"2190\" data-end=\"2548\">The Association expresses its gratitude to the leadership and team of the State Expert Centre for the open and constructive dialogue, the opportunity to present the industry\u2019s professional position, and their willingness to consider expert arguments. We hope that the Association\u2019s proposals will be carefully reviewed and taken into account in further work.<\/p>\n<p data-start=\"2550\" data-end=\"2833\" data-is-last-node=\"\" data-is-only-node=\"\">The EBA remains open to continued professional dialogue and ready to provide expert support to ensure the stable development of clinical trials in Ukraine, their harmonisation with European standards, and the safeguarding of the interests of patients, business and the state.<\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>On 10 February 2026, the Board of the Clinical Trials Subcommittee of the European Business Association held a working meeting with the newly appointed Director of the State Expert Centre of the Ministry of Health of Ukraine, Edem Adamanov, and representatives of the Centre. The meeting was attended by the Head of the Clinical Trials [&hellip;]<\/p>\n","protected":false},"author":33544,"featured_media":718121,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Meeting of the EBA Clinical Trials Subcommittee Board with the Director of the State Expert Centre of the Ministry of Health of Ukraine - European Business Association<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eba.com.ua\/zustrich-pravlinnya-pidkomitetu-klinichnyh-doslidzhen-eva-z-dyrektorom-dets-moz-ukrayiny\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Meeting of the EBA Clinical Trials Subcommittee Board with the Director of the State Expert Centre of the Ministry of Health of Ukraine - European Business Association\" \/>\n<meta property=\"og:description\" content=\"On 10 February 2026, the Board of the Clinical Trials Subcommittee of the European Business Association held a working meeting with the newly appointed Director of the State Expert Centre of the Ministry of Health of Ukraine, Edem Adamanov, and representatives of the Centre. 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