{"id":4247,"date":"2025-08-13T14:29:15","date_gmt":"2025-08-13T12:29:15","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=knowledge-hub&#038;p=4247"},"modified":"2025-11-21T12:45:27","modified_gmt":"2025-11-21T11:45:27","slug":"medicines-and-healthcare-products-regulatory-agency-mhra","status":"publish","type":"knowledge-hub","link":"https:\/\/fgk-group.com\/de\/knowledge-hub\/glossar\/medicines-and-healthcare-products-regulatory-agency-mhra\/","title":{"rendered":"Arzneimittel- und Gesundheitsprodukte-Regulierungsbeh\u00f6rde (MHRA)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4247\" class=\"elementor elementor-4247 elementor-570\" data-elementor-post-type=\"knowledge-hub\">\n\t\t\t\t<div class=\"elementor-element elementor-element-000b821 e-flex e-con-boxed e-con e-parent\" data-id=\"000b821\" 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-f8dfe83 elementor-widget elementor-widget-text-editor\" data-id=\"f8dfe83\" 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<span style=\"color: #000000;\">\u00a0<strong>britische Arzneimittelzulassungsbeh\u00f6rde (Medicines and Healthcare products Regulatory Agency, MHRA)<\/strong><\/span>\u00a0ist eine<span style=\"color: #000000;\">\u00a0<strong>Exekutivbeh\u00f6rde<\/strong>,<\/span> die f\u00fcr die\u00a0<span style=\"color: #000000;\"><strong>Regulierung von Arzneimitteln<\/strong>,\u00a0<\/span><strong><a href=\"\/de\/fgk-cro\/expertise\/medizinprodukte\/\">Medizinprodukten<\/a><\/strong>\u00a0und\u00a0<strong>B<span style=\"color: #000000;\">lutbestandteilen f\u00fcr Transfusionen im Vereinigten K\u00f6nigreich<\/span><\/strong><span style=\"color: #000000;\">\u00a0<\/span>zust\u00e4ndig ist. Die MHRA ist dem Ministerium f\u00fcr Gesundheit und Soziales unterstellt und hat die Aufgabe, sicherzustellen, dass diese Produkte<span style=\"color: #000000;\">\u00a0<strong>sicher<\/strong><\/span>\u00a0und<span style=\"color: #000000;\">\u00a0<strong>wirksam<\/strong><\/span>\u00a0sind und den einschl\u00e4gigen\u00a0<span style=\"color: #000000;\"><strong>Qualit\u00e4tsstandards<\/strong><\/span>\u00a0entsprechen, bevor sie auf den Markt gebracht und von der \u00d6ffentlichkeit verwendet werden.<\/p><p>Zu den Aufgaben der\u00a0<span style=\"color: #000000;\"><strong>MHRA geh\u00f6ren die Zulassung und \u00dcberwachung von Arzneimitteln<\/strong><\/span>\u00a0sowie die\u00a0<strong><span style=\"color: #000000;\">Markt\u00fcberwachung<\/span>\u00a0<\/strong>von Medizinprodukten. Bei Arzneimitteln \u00fcberwacht sie<strong>\u00a0<a href=\"\/de\/knowledge-hub\/glossar\/klinische-studie\/\">klinische Studien<\/a><\/strong>, wertet Sicherheitsdaten aus und erteilt Marktzulassungen. Die Beh\u00f6rde \u00fcberwacht auch unerw\u00fcnschte Arzneimittelwirkungen und ergreift Ma\u00dfnahmen, wenn Sicherheitsbedenken auftreten. Bei Medizinprodukten ist es das Ziel der MHRA, sicherzustellen, dass die Produkte den regulatorischen Standards entsprechen. Sie f\u00fchrt Inspektionen und eine\u00a0<a href=\"\/de\/knowledge-hub\/glossar\/post-market-surveillance-pms\/\"><strong>\u00dcberwachung<\/strong> <strong>nach der Marktzulassung<\/strong><\/a>\u00a0durch, um die Sicherheit und Leistung von Medizinprodukten zu verfolgen.<\/p><p>Neben der regulatorischen Aufsicht bietet die\u00a0<span style=\"color: #000000;\"><strong>MHRA Herstellern<\/strong>,\u00a0<strong>medizinischem Fachpersonal<\/strong><\/span>\u00a0und\u00a0<span style=\"color: #000000;\"><strong>der \u00d6ffentlichkeit\u00a0<\/strong><\/span>Orientierungshilfen\u00a0<span style=\"color: #000000;\"><strong>zum sicheren Gebrauch<\/strong><\/span>\u00a0und zu potenziellen Risiken im Zusammenhang mit Gesundheitsprodukten. Sie ist auch an der Festlegung von Standards f\u00fcr die Herstellung und Qualit\u00e4tskontrolle beteiligt.<\/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>Die britische Beh\u00f6rde, die f\u00fcr die Regulierung von Arzneimitteln, Medizinprodukten und Blutbestandteilen f\u00fcr Transfusionen zust\u00e4ndig ist.<\/p>\n","protected":false},"featured_media":0,"template":"","knowledge-hub-categories":[],"class_list":["post-4247","knowledge-hub","type-knowledge-hub","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Arzneimittel- und Gesundheitsprodukte-Regulierungsbeh\u00f6rde (MHRA) - FGK Group<\/title>\n<meta name=\"description\" content=\"In unserem FGK-Glossar f\u00fcr klinische Forschung erfahren Sie, wof\u00fcr der Begriff Medicines and Healthcare products Regulatory Agency (MHRA) steht.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fgk-group.com\/de\/knowledge-hub\/glossar\/medicines-and-healthcare-products-regulatory-agency-mhra\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Arzneimittel- und Gesundheitsprodukte-Regulierungsbeh\u00f6rde (MHRA) - 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