{"id":4235,"date":"2025-08-13T14:31:36","date_gmt":"2025-08-13T12:31:36","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=knowledge-hub&#038;p=4235"},"modified":"2025-11-21T14:01:03","modified_gmt":"2025-11-21T13:01:03","slug":"orphan-kennzeichnung","status":"publish","type":"knowledge-hub","link":"https:\/\/fgk-group.com\/de\/knowledge-hub\/glossar\/orphan-kennzeichnung\/","title":{"rendered":"Orphan-Kennzeichnung"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4235\" class=\"elementor elementor-4235 elementor-572\" data-elementor-post-type=\"knowledge-hub\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c5a3ec9 e-flex e-con-boxed e-con e-parent\" data-id=\"c5a3ec9\" 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-27bf4f9 elementor-widget elementor-widget-text-editor\" data-id=\"27bf4f9\" 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>Die<strong><span style=\"color: #000000;\">\u00a0Bereitstellung von Medikamenten f\u00fcr<\/span>\u00a0<a href=\"\/de\/fgk-cro\/expertise\/seltene-erkrankungen\/\">seltene Krankheiten <\/a><\/strong>war nicht rentabel, aber die Menschen brauchten sie trotzdem. Mit staatlicher Unterst\u00fctzung und Anreizen wie Steuergutschriften, Geb\u00fchrenbefreiungen und Markenschutz wurde die Entwicklung von<span style=\"color: #000000;\">\u00a0<strong>Orphan-Arzneimittel (= Medikamente)<\/strong><\/span>\u00a0f\u00fcr Pharmaunternehmen attraktiver. Das<span style=\"color: #000000;\">\u00a0<\/span><strong><span style=\"color: #000000;\">Medikament muss bestimmte Kriterien<\/span>\u00a0<\/strong>erf\u00fcllen, um von den Beh\u00f6rden als Orphan-Medizinprodukt anerkannt zu werden.<\/p><p>In der Europ\u00e4ischen Union verlangt die Verordnung (EG) Nr. 141\/2000 \u00fcber Arzneimittel f\u00fcr seltene Leiden, dass der\u00a0<strong><a href=\"\/de\/knowledge-hub\/glossar\/sponsor\/\">Sponsor<\/a>,<\/strong> der die Ausweisung eines Arzneimittels als Arzneimittel f\u00fcr seltene Leiden anstrebt oder erhalten hat, in der EU ans\u00e4ssig sein muss.<\/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>Ein in Europa gew\u00e4hrter Status f\u00fcr Arzneimittel zur Behandlung seltener Krankheiten, der Anreize zur F\u00f6rderung von Forschung und Entwicklung f\u00fcr ungedeckte medizinische Bed\u00fcrfnisse bietet.<\/p>\n","protected":false},"featured_media":0,"template":"","knowledge-hub-categories":[],"class_list":["post-4235","knowledge-hub","type-knowledge-hub","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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