{"id":6895,"date":"2025-09-08T06:53:06","date_gmt":"2025-09-08T04:53:06","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=news-events-news&#038;p=6895"},"modified":"2025-11-20T11:44:56","modified_gmt":"2025-11-20T10:44:56","slug":"martin-krauss-on-how-ctis-endangers-the-future-of-clinical-studies-in-europe","status":"publish","type":"news-events-news","link":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/martin-krauss-on-how-ctis-endangers-the-future-of-clinical-studies-in-europe\/","title":{"rendered":"Martin Krauss on how CTIS endangers the future of clinical studies in Europe"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6895\" class=\"elementor elementor-6895 elementor-2163\" data-elementor-post-type=\"news-events-news\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43f6113 e-flex e-con-boxed e-con e-parent\" data-id=\"43f6113\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c7c1c40 elementor-widget elementor-widget-text-editor\" data-id=\"c7c1c40\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t21\/Feb\/23\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-631bf9c elementor-widget elementor-widget-heading\" data-id=\"631bf9c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Martin Krauss on how CTIS endangers the future of clinical studies in Europe<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0dae795 elementor-widget elementor-widget-text-editor\" data-id=\"0dae795\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>One year after its launch, the CTIS portal suffers from serious deficiencies, severely impairing the application procedure for clinical studies in all of Europe.<\/p><p>Since end of January and after a one year transition period, approval for new clinical trials of medicinal products in Europe can only be done via the electronic CTIS portal of EMA. CTIS is part of EU Regulation 536\/2014 (CTR) and was installed to facilitate and expedite the approval process in Europe.<\/p><p>Instead, it\u2019s insufficient functionality now threatens the entire European landscape of drug research. The German magazine transkript published an article, which shows alarming figures: It is to be feared that the dysfunctionality of the CTIS portal will lead to a potentially permanent migration of drug trials to other regions of the world and in the worst case to significant deterioration in the supply situation of seriously ill patients with innovative drugs.<br \/>An alliance of industry organizations, including the BVMA (German Association for Contract Research Organizations), where FGK\u2019s Managing Director Martin Krauss is President, urge rapid action by politics to save the competitiveness of Europe as a research location:\u00a0<strong><a href=\"\/wp-content\/uploads\/2025\/11\/tk_1_2023_-_Auszug__Klinische_Studien_im_Sinkflug.pdf\" target=\"_blank\" rel=\"noopener\">Klinische Studien im Sinkflug<\/a>\u00a0\u00a0<\/strong> (\u00a9|transkript 1-2023)<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>One year after its launch, the CTIS portal suffers from serious deficiencies, severely impairing the application procedure for clinical studies in all\u2026<\/p>\n","protected":false},"template":"","class_list":["post-6895","news-events-news","type-news-events-news","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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