{"id":789655,"date":"2025-09-03T13:02:50","date_gmt":"2025-09-03T10:02:50","guid":{"rendered":""},"modified":"2025-09-03T13:04:37","modified_gmt":"2025-09-03T10:04:37","slug":"formuvannya-novogo-regulyatora-u-farmsferi-pidsumky-zustrichi-eba-ta-moz","status":"publish","type":"post","link":"https:\/\/new.eba.com.ua\/en\/formuvannya-novogo-regulyatora-u-farmsferi-pidsumky-zustrichi-eba-ta-moz\/","title":{"rendered":"Establishing a new regulator in the pharmaceutical sector: outcomes of the EBA\u2013MoH meeting"},"content":{"rendered":"<div class=\"slider__outer-container\">\n\t<div class=\"slider\">\n\n\t\t<div class=\"slider__container\">\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/09\/5307799114035101340.jpg\" data-full-src=\"https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/09\/5307799114035101340.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/new.eba.com.ua\/wp-content\/uploads\/2025\/09\/5307799114035101340.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\t<div class=\"slider__panel\">\n\n\t\t\t<div class=\"slider__info-container\">\n\n\t\t\t\t<div class=\"slider__counters\">\n\t\t\t\t\t<div class=\"container\">\n\t\t\t\t\t\t<span class=\"slider__counter slider__counter--current\">01<\/span>\/<span class=\"slider__counter slider__counter--total\"><\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t\t<div class=\"slider__title\">\n\t\t\t\t\t<div class=\"container\">\n\t\t\t\t\t\t<span class=\"slider__title__text\" style=\"display:none\">Photo: <\/span>\n\t\t\t\t\t\t<span class=\"slider__title__description\"><\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t<\/div>\n\n\t\t\t<div class=\"slider__nav slider__nav--prev icon icon-long-arrow\">\n\t\t\t\t<span class=\"icon icon-arrow-l-thin\"><\/span>\n\t\t\t<\/div>\n\t\t\t<div class=\"slider__nav slider__nav--next icon icon-long-arrow arrow-right\">\n\t\t\t<\/div>\n\n\t\t\t<div class=\"slider__fullscreen icon icon-full-size js_slick-fullscreen\"><\/div>\n\n\t\t<\/div>\n\n\t\t<span class=\"close-full-size\"><\/span>\n\n\t<\/div>\n<\/div>\n<p data-start=\"151\" data-end=\"641\">On 27 August, the Health Care Committee of the European Business Association held a working meeting with Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration. The main focus of the dialogue was the European integration of Ukraine\u2019s healthcare system and the creation of a new State Control Body, which is due to start operating simultaneously with the entry into force of the new <a href=\"https:\/\/eur03.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fzakon.rada.gov.ua%2Flaws%2Fshow%2F2469-20%23Text&amp;data=05%7C02%7CValeriia.Diachok%40new.eba.com.ua%7C8cff2d7f1ae0494d627c08ddea2ffb99%7C92456a16661b498eadd5e224c7dd6afa%7C0%7C0%7C638924214040589306%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=5On2b5qHwr04WP3wVy4r8lqK1hDPKj%2BNhxmH3pFn6zU%3D&amp;reserved=0\">Law of Ukraine \u201cOn Medicinal Products\u201d No. 2469-IX<\/a> on 1 January 2027.<\/p>\n<p data-start=\"643\" data-end=\"1250\">For industry representatives, the establishment and operation of the SCB is a key issue, as it is expected to become the foundation of a modern regulatory system for medicinal products and medical devices, as well as an important step in preparing the pharmaceutical market for Ukraine\u2019s future EU membership. Work is currently under way on developing a methodology for calculating contributions and fees, which, in the Committee\u2019s view, should ensure a sustainable, transparent, and financially independent model for the SCB\u2019s operation, proportionate to the country\u2019s economic capacity and market needs.<\/p>\n<p data-start=\"1252\" data-end=\"1346\">The participants exchanged views and agreed on common benchmarks in the following key areas:<\/p>\n<ul>\n<li data-start=\"1252\" data-end=\"1346\">creating the SCB as the cornerstone of a modern supervision system;<\/li>\n<li data-start=\"1252\" data-end=\"1346\">implementing the Twinning project as a tool for introducing best European practices;<\/li>\n<li data-start=\"1252\" data-end=\"1346\">harmonising the regulation of circulation and production of medical devices with EU legislation.<\/li>\n<\/ul>\n<p data-start=\"1610\" data-end=\"1865\">In addition, the discussion covered preparations for EMA benchmarking in 2027, as well as the stages of establishing the SCB and institutional matters (the competitive selection process for the SCB\u2019s head and the recruitment of key staff, among others).<\/p>\n<p data-start=\"1867\" data-end=\"2298\">The European Business Association sincerely thanks Maryna Slobodnichenko for her openness to dialogue, constructive approach, and readiness to take into account the business community\u2019s proposals. Meeting participants expressed their commitment to continued effective cooperation to ensure that the new regulatory instruments for both the state and the market deliver tangible results and remain aligned with patients\u2019 interests.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 27 August, the Health Care Committee of the European Business Association held a working meeting with Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration. The main focus of the dialogue was the European integration of Ukraine\u2019s healthcare system and the creation of a new State Control Body, which is due to [&hellip;]<\/p>\n","protected":false},"author":33544,"featured_media":667860,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[15564,15563,15574,15571],"tags":[],"class_list":["post-789655","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","category-press-releases-en"],"_links":{"self":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/789655","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=789655"}],"version-history":[{"count":0,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/789655\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media\/667860"}],"wp:attachment":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media?parent=789655"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/categories?post=789655"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/tags?post=789655"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}