{"id":789404,"date":"2025-03-04T11:42:16","date_gmt":"2025-03-04T09:42:16","guid":{"rendered":""},"modified":"2025-03-04T13:04:16","modified_gmt":"2025-03-04T11:04:16","slug":"vazhlyvi-zakonodavchi-zminy-u-sferi-klinichnyh-doslidzhen","status":"publish","type":"post","link":"https:\/\/new.eba.com.ua\/en\/vazhlyvi-zakonodavchi-zminy-u-sferi-klinichnyh-doslidzhen\/","title":{"rendered":"Important legislative changes in the field of clinical trials"},"content":{"rendered":"<p><span lang=\"en-US\"><a title=\"\u0412\u0438\u0445\u0456\u0434\u043d\u0430 URL-\u0430\u0434\u0440\u0435\u0441\u0430: https:\/\/zakon.rada.gov.ua\/laws\/show\/4239-20#Text. \u041a\u043b\u0430\u0446\u043d\u0456\u0442\u044c \u0430\u0431\u043e \u0442\u043e\u0440\u043a\u043d\u0456\u0442\u044c\u0441\u044f, \u044f\u043a\u0449\u043e \u0432\u0438 \u0434\u043e\u0432\u0456\u0440\u044f\u0454\u0442\u0435 \u0446\u044c\u043e\u043c\u0443 \u043f\u043e\u0441\u0438\u043b\u0430\u043d\u043d\u044e.\" href=\"https:\/\/eur03.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fzakon.rada.gov.ua%2Flaws%2Fshow%2F4239-20%23Text&amp;data=05%7C02%7CValeriia.Diachok%40new.eba.com.ua%7C015021ecca0d453582a708dd5aff5940%7C92456a16661b498eadd5e224c7dd6afa%7C0%7C0%7C638766774943261882%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=kVURSi82vI1G7wTRY2XLa2i0geOI0P%2FgrNXmwP%2BZXFQ%3D&amp;reserved=0\" target=\"_blank\" rel=\"noopener noreferrer\" data-auth=\"NotApplicable\" data-linkindex=\"2\" data-ogsc=\"\">The Law of Ukraine <\/a>&#8220;On Amendments to Certain Laws of Ukraine Regarding the Peculiarities of State Registration of Medicines That Can Be Purchased by a Person Authorized to Carry Out Procurement in the Field of Health Care and the Settlement of Certain Issues Related to the Sale of Medicines&#8221; dated 12.02.2025 No. 4239-IX entered into force on 28.02.2025 and will be introduced into force on 28.04.2025.<\/span><\/p>\n<p><span lang=\"en-US\">Law No. 4239-IX, among other significant changes for the pharmaceutical market, amends<b> the\u00a0 new Law of Ukraine &#8220;On Medicines&#8221;<\/b> 2469-IX dated 28.07.2022 \u2013 from now on it <b>will enter into force on January 1, 2027<\/b>. <\/span><\/p>\n<p><span lang=\"en-US\">Accelerating the enactment of the new Law of Ukraine &#8220;On Medicines&#8221; is important for further harmonization with the EU requirements, opening up new opportunities for Ukraine to further develop the CTs: <\/span><\/p>\n<ul type=\"disc\">\n<li><span lang=\"en-US\">improvement of regulatory requirements,<\/span><\/li>\n<li><span lang=\"en-US\">improving patients&#8217; access to free innovative treatment, in particular through programs for access of study subjects to the investigational medicinal product after the completion of their participation in a clinical trial,<\/span><\/li>\n<li><span lang=\"en-US\">strengthening Ukraine&#8217;s position as an attractive location for international research.<\/span><\/li>\n<\/ul>\n<p><span lang=\"en-US\">It should be noted that the Law No. 4239-IX, along with the acceleration of the enactment of the new law &#8220;On Medicines&#8221;, <b>postponed for a year the introduction of some serious changes<\/b>, for which it is necessary to prepare accordingly. Such changes for the CTs sphere are<b> licensing of import of investigational medicinal products<\/b> (IMP) and <b>GMP<\/b> <b>inspection of IMP production<\/b> (paragraph two of part sixteen of Article 10, part two of Article 42), which will come into force <b>on January 1, 2028<\/b>. <\/span><\/p>\n<p><span lang=\"en-US\">The EBA Clinical Trials Subcommittee managed to convey the importance of these changes to lawmakers. The EBA is grateful for taking into account the position of business and creating conditions for adaptation of the market to new regulatory requirements. Thus, the year of the transition period will allow all participants of CTS sphere to properly prepare for the implementation of new requirements and avoid the risk of blocking the IMP import during this period. In addition, logistics companies will have the time necessary to obtain a license to IMP import to Ukraine, which will ensure the continuity of clinical trials.<\/span><\/p>\n<p><span lang=\"en-US\">We would like to remind you about some innovations of the new law &#8220;On Medicines&#8221;, which improve the regulatory environment for the development of CD in Ukraine: <\/span><\/p>\n<ul type=\"disc\">\n<li><span lang=\"en-US\">introduction of CTs approval, including the examination of materials, by the new unified regulatory body of Ukraine \u2013 the State Control Body (UEC),<\/span><\/li>\n<li><span lang=\"en-US\">differentiation of regulation for interventional, law-interventional and non-interventional clinical trials of medicines with clearly established terms and the need to adopt separate procedures for the organization and requirements for conducting certain types of clinical trials. This will contribute to the development of such CTs in Ukraine, as well as better protection of the rights of the CT subjects,<\/span><\/li>\n<li><span lang=\"en-US\">settlement of problems involving minors and special groups of patients, in particular the definition of requirements and the need to adopt separate procedures in this regard,<\/span><\/li>\n<li><span lang=\"en-US\">introduction of a shortened period for obtaining permission to conduct international multicenter CTs, the protocols of which have been agreed in countries with strict regulatory authorities (SRAs) or in EU member states, <\/span><\/li>\n<li><span lang=\"en-US\">bringing terminology in line with EU requirements, in particular regarding the definitions of types of CTs, sponsor, CT register, inspection of CTs, which is entrusted to officials of the UEC, etc.<\/span><\/li>\n<\/ul>\n<p><span lang=\"en-US\">Currently, the EBA Clinical Trials Subcommittee is actively working on regulations to meet the requirements of the new Law &#8220;On Medicines&#8221;, in particular, on <a title=\"\u0412\u0438\u0445\u0456\u0434\u043d\u0430 URL-\u0430\u0434\u0440\u0435\u0441\u0430: https:\/\/moz.gov.ua\/uk\/povidomlennya-pro-oprilyudnennya-proyektu-nakazu-ministerstva-ohoroni-zdorov-ya-ukrayini-deyaki-pitannya-provedennya-klinichnih-doslidzhen-viprobuvan-likarskih-zasobiv. \u041a\u043b\u0430\u0446\u043d\u0456\u0442\u044c \u0430\u0431\u043e \u0442\u043e\u0440\u043a\u043d\u0456\u0442\u044c\u0441\u044f, \u044f\u043a\u0449\u043e \u0432\u0438 \u0434\u043e\u0432\u0456\u0440\u044f\u0454\u0442\u0435 \u0446\u044c\u043e\u043c\u0443 \u043f\u043e\u0441\u0438\u043b\u0430\u043d\u043d\u044e.\" href=\"https:\/\/eur03.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fmoz.gov.ua%2Fuk%2Fpovidomlennya-pro-oprilyudnennya-proyektu-nakazu-ministerstva-ohoroni-zdorov-ya-ukrayini-deyaki-pitannya-provedennya-klinichnih-doslidzhen-viprobuvan-likarskih-zasobiv&amp;data=05%7C02%7CValeriia.Diachok%40new.eba.com.ua%7C015021ecca0d453582a708dd5aff5940%7C92456a16661b498eadd5e224c7dd6afa%7C0%7C0%7C638766774943282779%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=Sgdu7PV0SEDl92urnWZ6027Uu9kp%2BivGzl6Ohv6yuTI%3D&amp;reserved=0\" target=\"_blank\" rel=\"noopener noreferrer\" data-auth=\"NotApplicable\" data-linkindex=\"3\" data-ogsc=\"\">the draft order of the Ministry of Health of Ukraine &#8220;Certain Issues of Conducting Clinical Trials (Trials) of Medicinal Products&#8221;,<\/a> published for public discussion on February 24, 2025, the draft of new Licensing Requirements, etc.<\/span><\/p>\n<p><span lang=\"en-US\"><span class=\"mark77rsue2i3 uM2yb\" data-markjs=\"true\">Congratulations<\/span> to the community on this important step! Together, we create favorable conditions for the development of science, innovations and access of Ukrainian patients to the most modern treatment.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Law of Ukraine &#8220;On Amendments to Certain Laws of Ukraine Regarding the Peculiarities of State Registration of Medicines That Can Be Purchased by a Person Authorized to Carry Out Procurement in the Field of Health Care and the Settlement of Certain Issues Related to the Sale of Medicines&#8221; dated 12.02.2025 No. 4239-IX entered into [&hellip;]<\/p>\n","protected":false},"author":33544,"featured_media":625151,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[15564,15563,15574],"tags":[],"class_list":["post-789404","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lobbying-news-en","category-main-news-en","category-news-and-articles-from-association-en"],"_links":{"self":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/789404","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/users\/33544"}],"replies":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/comments?post=789404"}],"version-history":[{"count":0,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/789404\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media\/625151"}],"wp:attachment":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media?parent=789404"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/categories?post=789404"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/tags?post=789404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}