{"id":649954,"date":"2025-06-11T10:20:32","date_gmt":"2025-06-11T07:20:32","guid":{"rendered":"https:\/\/eba.com.ua\/?p=649954"},"modified":"2025-06-11T10:20:32","modified_gmt":"2025-06-11T07:20:32","slug":"obgovorennya-novogo-poryadku-provedennya-klinichnyh-doslidzhen-zustrich-biznes-spilnoty-asotsiatsiyi-z-dets","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/obgovorennya-novogo-poryadku-provedennya-klinichnyh-doslidzhen-zustrich-biznes-spilnoty-asotsiatsiyi-z-dets\/","title":{"rendered":"[:ua]\u041e\u0431\u0433\u043e\u0432\u043e\u0440\u0435\u043d\u043d\u044f \u043d\u043e\u0432\u043e\u0433\u043e \u041f\u043e\u0440\u044f\u0434\u043a\u0443 \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0438\u0445 \u0434\u043e\u0441\u043b\u0456\u0434\u0436\u0435\u043d\u044c: \u0437\u0443\u0441\u0442\u0440\u0456\u0447 \u0431\u0456\u0437\u043d\u0435\u0441-\u0441\u043f\u0456\u043b\u044c\u043d\u043e\u0442\u0438 \u0410\u0441\u043e\u0446\u0456\u0430\u0446\u0456\u0457 \u0437 \u0414\u0415\u0426[:en]Discussion on the new procedure for conducting clinical trials: EBA business community meets with the State Expert Center[:]"},"content":{"rendered":"<p><\/p>\n<p data-start=\"187\" data-end=\"797\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-649955 size-full\" src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440.png\" alt=\"\" width=\"1915\" height=\"1027\" srcset=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440.png 1915w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440-300x161.png 300w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440-1024x549.png 1024w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440-768x412.png 768w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440-1536x824.png 1536w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440-650x349.png 650w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440-800x429.png 800w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440-170x90.png 170w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/06\/Screenshot_440-100x54.png 100w\" sizes=\"(max-width: 1915px) 100vw, 1915px\" \/>Representatives of the Clinical Trials Subcommittee of the European Business Association took part in a meeting with experts from the State Expert Center of the Ministry of Health of Ukraine, held on 29 May 2025 under the chairmanship of Mykhailo Lobas, Deputy Director for Clinical Affairs. The discussion focused on the updated Draft Order of the Ministry of Health \u201cCertain Issues of Conducting Clinical Trials of Medicinal Products\u201d. Ta\u0456sa Herasymchuk, Director of the Clinical Trials Department, provided an update on the status of feedback processing following the public consultation on the Draft Order.<\/p>\n<p data-start=\"799\" data-end=\"1298\">As a reminder, on 24 February 2025, the Ministry of Health published the Draft Order \u201cCertain Issues of Conducting Clinical Trials of Medicinal Products\u201d on its official website for public discussion. The document includes a revised Procedure for conducting clinical trials (with 18 annexes); a Model Regulation on Ethics Committees; and Requirements for the format and content of informed consent. This comprehensive update to the regulatory framework is of great importance to the entire sector.<\/p>\n<p data-start=\"1300\" data-end=\"1587\">The EBA\u2019s Clinical Trials Subcommittee has been actively involved in the regulatory update process, given the upcoming entry into force of the Law of Ukraine \u201cOn Medicinal Products\u201d No. 2469-IX on 1 January 2027 and the need to harmonise Ukrainian legislation with European requirements.<\/p>\n<p data-start=\"1589\" data-end=\"1830\">The EBA submitted a set of comprehensive written proposals to the Draft Order, which experts consider critical to addressing regulatory gaps, eliminating legal ambiguities, and ensuring compliance with modern international standards.<\/p>\n<p data-start=\"1832\" data-end=\"1894\">Key proposals and recommendations of the Subcommittee include:<\/p>\n<ul data-start=\"1895\" data-end=\"2979\">\n<li data-start=\"1895\" data-end=\"2124\">\n<p data-start=\"1897\" data-end=\"2124\">Incorporating the updated version of ICH GCP E6(R3), published on 6 January 2025, including provisions on digital technology integration, improvements to the informed consent process, and strengthened patient rights protection;<\/p>\n<\/li>\n<li data-start=\"2125\" data-end=\"2246\">\n<p data-start=\"2127\" data-end=\"2246\">Recognising the possibility of obtaining informed consent remotely as a key component of decentralised clinical trials;<\/p>\n<\/li>\n<li data-start=\"2247\" data-end=\"2364\">\n<p data-start=\"2249\" data-end=\"2364\">Introducing provisions on electronic data management systems and other modern tools for conducting clinical trials;<\/p>\n<\/li>\n<li data-start=\"2365\" data-end=\"2450\">\n<p data-start=\"2367\" data-end=\"2450\">Improving Sections XI and XIII in line with EU Regulation No. 536\/2014 and ICH GCP;<\/p>\n<\/li>\n<li data-start=\"2451\" data-end=\"2549\">\n<p data-start=\"2453\" data-end=\"2549\">Updating the Model Regulation on Ethics Committees to reflect European approaches to their work;<\/p>\n<\/li>\n<li data-start=\"2550\" data-end=\"2723\">\n<p data-start=\"2552\" data-end=\"2723\">Revising the procedures for approval of substantial amendments and trial start-up, taking into account the launch of the new regulatory body \u2013 the State Control Authority;<\/p>\n<\/li>\n<li data-start=\"2724\" data-end=\"2820\">\n<p data-start=\"2726\" data-end=\"2820\">Clarifying provisions regarding the payment for the expert review of clinical trial materials;<\/p>\n<\/li>\n<li data-start=\"2821\" data-end=\"2861\">\n<p data-start=\"2823\" data-end=\"2861\">Refining the annexes to the Procedure;<\/p>\n<\/li>\n<li data-start=\"2862\" data-end=\"2979\">\n<p data-start=\"2864\" data-end=\"2979\">Unifying terminology in accordance with Law No. 2469-IX, EU Regulation No. 536\/2014, and ICH GCP E6(R3) guidelines.<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2981\" data-end=\"3242\">Ms Ta\u0456sa Herasymchuk expressed gratitude for the submitted proposals and noted that a significant number of them would be taken into account during the revision of the Draft Order. The updated version will be submitted for a second round of public consultation.<\/p>\n<p data-start=\"3244\" data-end=\"3695\" data-is-last-node=\"\" data-is-only-node=\"\">The EBA\u2019s Clinical Trials Subcommittee expresses its appreciation to the team at the State Expert Center for their openness to dialogue, collaboration, and willingness to consider the business community\u2019s position. The EBA confirms its readiness to contribute further proposals during the next public consultation and to continue cooperating to create a modern, transparent, and effective regulatory environment for clinical trials in Ukraine.<\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Representatives of the Clinical Trials Subcommittee of the European Business Association took part in a meeting with experts from the State Expert Center of the Ministry of Health of Ukraine, held on 29 May 2025 under the chairmanship of Mykhailo Lobas, Deputy Director for Clinical Affairs. The discussion focused on the updated Draft Order of [&hellip;]<\/p>\n","protected":false},"author":33544,"featured_media":649955,"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>Discussion on the new procedure for conducting clinical trials: EBA business community meets with the State Expert Center - 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\/obgovorennya-novogo-poryadku-provedennya-klinichnyh-doslidzhen-zustrich-biznes-spilnoty-asotsiatsiyi-z-dets\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Discussion on the new procedure for conducting clinical trials: EBA business community meets with the State Expert Center - European Business Association\" \/>\n<meta property=\"og:description\" content=\"Representatives of the Clinical Trials Subcommittee of the European Business Association took part in a meeting with experts from the State Expert Center of the Ministry of Health of Ukraine, held on 29 May 2025 under the chairmanship of Mykhailo Lobas, Deputy Director for Clinical Affairs. 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