{"id":1102,"date":"2024-10-04T14:41:47","date_gmt":"2024-10-04T13:41:47","guid":{"rendered":"https:\/\/dev.oximio.com\/?post_type=oximio-resources&#038;p=1102"},"modified":"2024-10-18T06:25:24","modified_gmt":"2024-10-18T05:25:24","slug":"changes-to-clinical-trial-procedures-in-ukraine-effective-june-13-2024","status":"publish","type":"oximio-resources","link":"https:\/\/oximio.com\/resources\/changes-to-clinical-trial-procedures-in-ukraine-effective-june-13-2024\/","title":{"rendered":"Changes to Clinical Trial Procedures in Ukraine Effective June 13, 2024"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1102\" class=\"elementor elementor-1102\">\n\t\t\t\t<section class=\"elementor-element elementor-element-7d405423 e-con-full e-flex e-con e-parent\" data-id=\"7d405423\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7ac66c33 e-flex e-con-boxed e-con e-child\" data-id=\"7ac66c33\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4365b7c1 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"4365b7c1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Ministry of Health of Ukraine has announced the introduction of new changes to the procedures for conducting clinical trials of medicinal products and the examination of clinical trial materials from 13 June 2024. This welcome change is the result of the dedicated efforts by the EBA Clinical Trial Subcommittee of which Oximio worked hard alongside other industry players to bring about.<\/p><h2>Key Changes:<\/h2><p><strong>Reduced Examination Timeframes<\/strong>:<br \/><br \/><\/p><ul><li style=\"list-style-type: none;\"><ul><li>The timeframe for examining clinical trial materials for advanced therapy medicinal products has been shortened from 90 to 79 calendar days. This includes a 15-day preliminary examination and a 64-day specialised examination.<br \/><br \/><\/li><li>The examination period for significant amendments to the protocol of clinical trials involving advanced therapy medicinal products is now 68 calendar days, down from the previous 79. This period consists of an 11-day preliminary examination and a 57-day specialised examination.<br \/><br \/><\/li><li>The examination period can be extended by up to 50 calendar days for additional consultations with specialists. This will be communicated to applicants.<\/li><\/ul><\/li><\/ul><p>\u00a0<\/p><p><strong>Updated Insurance Requirements<\/strong>:<br \/><br \/><\/p><ul><li style=\"list-style-type: none;\"><ul><li style=\"list-style-type: none;\"><ul><li>Sponsors of clinical trials must now conclude an insurance contract covering their liability to third parties for any harm caused to subjects (patients or healthy volunteers) during the trial. This is in accordance with insurance class 13 under Article 4 of the Law of Ukraine \u201cOn Insurance,\u201d instead of the previous requirement for a patient (volunteer) life and health insurance contract.<\/li><\/ul><\/li><\/ul><\/li><\/ul><p><strong><br \/>Terminology Updates<\/strong>:<\/p><ul><li style=\"list-style-type: none;\"><ul><li>The terminology for \u201csubjects\u201d, \u201csponsors\u201d and \u201cinvestigated\u201d has been revised and will change to \u201csubject of research\u201d, \u201csponsor of a clinical trial\u201d and \u201cinvestigated medicinal product\u201d.<br \/><br \/><\/li><\/ul><\/li><\/ul><p><a href=\"https:\/\/zakon.rada.gov.ua\/laws\/show\/z0869-24#n5\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">View the complete Ministry of Health notification online<\/span><\/a>.<\/p><p>These updates aim to streamline the clinical trial process, ensuring faster and more efficient evaluations while maintaining high standards of safety and compliance. For further details or questions regarding these changes, please don\u2019t hesitate to\u00a0<a href=\"https:\/\/oximio.com\/contact-us\/\"><span style=\"text-decoration: underline;\">contact us<\/span><\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t<section class=\"elementor-element elementor-element-1a5d8422 e-con-full e-flex e-con e-parent\" data-id=\"1a5d8422\" data-element_type=\"container\">\n\t\t\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":1104,"template":"","meta":{"_acf_changed":false},"resources-categories":[10],"class_list":["post-1102","oximio-resources","type-oximio-resources","status-publish","has-post-thumbnail","hentry","resources-categories-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clinical Trial Procedures | Ukraine Update 2024<\/title>\n<meta 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