{"id":9748,"date":"2026-04-01T11:48:47","date_gmt":"2026-04-01T03:48:47","guid":{"rendered":"https:\/\/regask.com\/?p=9748"},"modified":"2026-04-01T15:51:32","modified_gmt":"2026-04-01T07:51:32","slug":"die-britische-arzneimittelbehorde-mhra-legt-einen-regulatorischen-weg-fest-um-tierversuche-in-der-arzneimittelentwicklung-schrittweise-abzuschaffen","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/uk-mhra-sets-regulatory-pathway-to-phase-out-animal-testing-in-drug-development\/","title":{"rendered":"Die britische Arzneimittelbeh\u00f6rde MHRA legt regulatorischen Weg zur schrittweisen Abschaffung von Tierversuchen fest\u2026"},"content":{"rendered":"<p>Am 24. M\u00e4rz 2026 <strong>Arzneimittel- und Gesundheitsprodukte-Regulierungsbeh\u00f6rde<\/strong> Die MHRA hat neue regulatorische Grunds\u00e4tze eingef\u00fchrt f\u00fcr <strong>Zulassungsantr\u00e4ge f\u00fcr Humanarzneimittel<\/strong> die sich darauf verlassen <strong>Nicht-tierische Beweise.<\/strong> Dieses Update unterst\u00fctzt die umfassendere Strategie der britischen Regierung zur Reduzierung und zum Ersatz von Tierversuchen und gilt f\u00fcr alle Arzneimittel, die Tierversuche durchf\u00fchren. <strong>Zulassung f\u00fcr den Markt (MA)<\/strong> im Vereinigten K\u00f6nigreich.<\/p>\n<div class=\"row\"  id=\"row-1346354180\">\n\n\t<div id=\"col-1818387865\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-941754196\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-941754196 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-1559561276\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1559561276 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die MHRA hat Folgendes festgestellt:\u00a0<\/span><b><span data-contrast=\"auto\">f\u00fcnf Regulierungsprinzipien<\/span><\/b><span data-contrast=\"auto\">\u00a0Festlegung, wann Tierversuche erforderlich, optional oder entbehrlich sind.\u00a0<\/span><b><span data-contrast=\"auto\">Generische, biosimilare und pharmakologisch inaktive Produkte<\/span><\/b><span data-contrast=\"auto\">\u00a0sollten nicht an Tieren getestet werden,\u00a0<\/span><b><span data-contrast=\"auto\">Toxizit\u00e4tspr\u00fcfung f\u00fcr Biologika<\/span><\/b><span data-contrast=\"auto\">\u00a0muss auf pharmakologisch relevante Spezies beschr\u00e4nkt sein. Die Beh\u00f6rde erlaubt au\u00dferdem\u00a0<\/span><b><span data-contrast=\"auto\">Produkte mit gut verstandenen pharmakologischen Profilen<\/span><\/b><span data-contrast=\"auto\">\u00a0um ohne vorherige Tierversuche an klinischen Studien in Gro\u00dfbritannien teilnehmen zu k\u00f6nnen.,\u00a0<\/span><b><span data-contrast=\"auto\">Produkte mit neuartigen pharmakologischen Mechanismen<\/span><\/b><span data-contrast=\"auto\">\u00a0m\u00fcssen weiterhin die internationalen Anforderungen an Tierversuche erf\u00fcllt werden.,\u00a0<\/span><b><span data-contrast=\"auto\">Impfstoffe gegen neu auftretende pandemische Infektionskrankheiten<\/span><\/b><span data-contrast=\"auto\">, Wo die Wirksamkeit nicht in klinischen Studien beurteilt werden kann, muss weiterhin auf Tierversuche zur\u00fcckgegriffen werden.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Um die Einf\u00fchrung von\u00a0<\/span><b><span data-contrast=\"auto\">Neue methodische Ans\u00e4tze (NAMs)<\/span><\/b><span data-contrast=\"auto\">, einschlie\u00dflich von Menschen entwickelter Modelle und KI-gest\u00fctzter Analysen, wird die MHRA einf\u00fchren\u00a0<\/span><b><span data-contrast=\"auto\">Vorabpr\u00fcfungsplan f\u00fcr Modul 4<\/span><\/b><span data-contrast=\"auto\">\u00a0bis Ende 2026. Dies erm\u00f6glicht es Unternehmen, die Produkte ohne Tierversuche entwickeln, einen entsprechenden Antrag einzureichen.\u00a0<\/span><b><span data-contrast=\"auto\">Modul 4<\/span><\/b><span data-contrast=\"auto\">, Die\u00a0<\/span><b><span data-contrast=\"auto\">Ermittlerbrosch\u00fcre<\/span><\/b><span data-contrast=\"auto\">, und mindestens einen Bericht \u00fcber eine klinische Studie zur fr\u00fchzeitigen Bewertung. Die Beh\u00f6rde wird einen bereitstellen\u00a0<\/span><b><span data-contrast=\"auto\">unverbindliche schriftliche Stellungnahme<\/span><\/b><span data-contrast=\"auto\">\u00a0zur Datenangemessenheit, die in den endg\u00fcltigen Zulassungsantrag aufgenommen werden kann.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Die MHRA wird in Absprache mit der\u00a0<\/span><b><span data-contrast=\"auto\">Kommission f\u00fcr Humanarzneimittel<\/span><\/b><span data-contrast=\"auto\">,die letztendlich \u00fcber die Bef\u00fcrwortung oder Ablehnung des Antrags entscheidet, wobei im Falle einer Ablehnung Gr\u00fcnde angegeben werden m\u00fcssen.\u00a0<\/span><b><span data-contrast=\"auto\">Kostendeckungsgeb\u00fchr<\/span><\/b><span data-contrast=\"auto\">\u00a0wird f\u00fcr Voranmeldungen gelten, um ungeeignete Bewerbungen zu verhindern, wobei die genaue Geb\u00fchr noch nicht festgelegt wurde.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Es ist wichtig zu beachten, dass dieses Vorabpr\u00fcfungsverfahren nur f\u00fcr folgende Personen gilt:\u00a0<\/span><b><span data-contrast=\"auto\">Antr\u00e4ge auf Marktzulassung<\/span><\/b><span data-contrast=\"auto\">\u00a0und hat keine Auswirkungen\u00a0<\/span><b><span data-contrast=\"auto\">Genehmigung klinischer Studien<\/span><\/b><span data-contrast=\"auto\">\u00a0Verfahren.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p>Diese Initiative steht im Einklang mit der Strategie der britischen Regierung f\u00fcr November 2025., <strong>\u201cTierversuche in der Wissenschaft ersetzen: Eine Strategie zur Unterst\u00fctzung der Entwicklung, Validierung und Anwendung alternativer Methoden.\u201d<\/strong> Es verst\u00e4rkt den regulatorischen Wandel hin zu <strong>Rahmenbedingungen f\u00fcr Tierversuche<\/strong> in der Arzneimittelentwicklung.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1818387865 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-454253826\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Zeitleisten<\/h2>\n\t<div id=\"gap-342529091\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-342529091 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Der <strong>Fortgeschrittenen-Modul-4-\u00dcberpr\u00fcfungsprogramm<\/strong> wird voraussichtlich bis zum <strong>Ende 2026. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-454253826 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-311950611\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Warum es wichtig ist<\/h2>\n\t<div id=\"gap-934970751\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-934970751 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update bietet <strong>klare regulatorische Leitlinien<\/strong> zur Verwendung von nicht-tierischen Beweismitteln, die eine gr\u00f6\u00dfere<strong> regulatorische Sicherheit<\/strong> f\u00fcr Pharma- und Biotechnologieunternehmen. Durch die Formalisierung der Bedingungen, unter denen Tierversuche reduziert oder vermieden werden k\u00f6nnen, unterst\u00fctzt die MHRA <strong>digitale und wissenschaftliche Innovation<\/strong>, einschlie\u00dflich KI-gest\u00fctzter Methoden. Die Einf\u00fchrung eines Vorabpr\u00fcfungsmechanismus k\u00f6nnte dies verbessern.<strong> Entwicklungseffizienz<\/strong> und die Beweisrisiken zu reduzieren, w\u00e4hrend gleichzeitig die regulatorische Strenge gewahrt und unn\u00f6tige Belastungen minimiert werden.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-311950611 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-468589763\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Wen das betrifft<\/h2>\n\t<div id=\"gap-197813839\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-197813839 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\">Dieses Update ist relevant f\u00fcr\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\">Teams f\u00fcr regulatorische Angelegenheiten, Forschung und Entwicklung, Qualit\u00e4tssicherung und Finanzen<\/span><\/span><\/strong><span class=\"TextRun SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\">\u00a0innerhalb von Pharma- und Biotechnologieunternehmen. Die Beteiligten m\u00fcssen bewerten, inwieweit die neuen Grunds\u00e4tze auf ihre Produktpipelines anwendbar sind.,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW120779043 BCX0\">insbesondere f\u00fcr<\/span><span class=\"NormalTextRun SCXW120779043 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\">Biologika, Generika, Biosimilars und neuartige Therapien<\/span><\/span><\/strong><span class=\"TextRun SCXW120779043 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW120779043 BCX0\"><strong>,<\/strong> und die Bereitschaft zur Einhaltung der MHRA-Vorgaben sicherzustellen.<\/span><\/span><span class=\"EOP SCXW120779043 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-468589763 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-642356963\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>N\u00e4chste Schritte<\/h2>\n\t<div id=\"gap-1707127913\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1707127913 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Organisationen sollten die vollst\u00e4ndigen MHRA-Richtlinien pr\u00fcfen, um festzustellen, wie die\u00a0<\/span><b><span data-contrast=\"auto\">f\u00fcnf Regulierungsprinzipien<\/span><\/b><span data-contrast=\"auto\">\u00a0auf ihre Produkte anwenden und den strategischen Wert der\u00a0<\/span><b><span data-contrast=\"auto\">Vorab-Einreichungsschema f\u00fcr Modul 4<\/span><\/b><span data-contrast=\"auto\">\u00a0Vor der Implementierung sollten die Teams auch die Angemessenheit von\u00a0<\/span><b><span data-contrast=\"auto\">Nicht-Tierdatenpakete<\/span><\/b><span data-contrast=\"auto\">, die Studiendesigns nichtklinischer Studien an den aktualisierten Rahmen anpassen und potenzielle\u00a0<\/span><b><span data-contrast=\"auto\">Kostendeckungsgeb\u00fchren<\/span><\/b><span data-contrast=\"auto\">\u00a0in der Entwicklungsplanung.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Da sich die regulatorischen Erwartungen weiterentwickeln\u00a0<\/span><b><span data-contrast=\"auto\">Tierfreie Methoden und KI-gest\u00fctzte Evidenz<\/span><\/b><span data-contrast=\"auto\">, Um globalen Ver\u00e4nderungen stets einen Schritt voraus zu sein, ist es entscheidend. RegASK ist eine f\u00fchrende agentenbasierte KI-Plattform f\u00fcr regulatorische Analysen und Workflow-Orchestrierung, die globale Unternehmen in stark regulierten Branchen wie Konsumg\u00fcter und Life Sciences dabei unterst\u00fctzt, sich proaktiv in komplexen regulatorischen Umfeldern zu bewegen. Durch die Kombination fortschrittlicher agentenbasierter KI mit Expertenwissen\u2026, <a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a> liefert zeitnahe, vorausschauende und umsetzbare Erkenntnisse sowie eine durchg\u00e4ngige Automatisierung, optimiert Compliance-Prozesse, mindert Risiken und beschleunigt den Marktzugang in mehr als 160 L\u00e4ndern. <strong><a href=\"http:\/\/regask.com\/de\/\">Mehr erfahren<\/a> oder <a href=\"https:\/\/regask.com\/de\/demo-buchen\/\">Jetzt Demo buchen.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-642356963 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-423401849\">\n\n\t<div id=\"col-1816113005\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQs<\/h3>\n\t<div id=\"gap-1300360598\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1300360598 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW126598592 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW126598592 BCX0\">Was sind neue methodische Ans\u00e4tze (New Approach Methodologies, NAMs) in der Arzneimittelentwicklung?<\/span><\/span><span class=\"EOP SCXW126598592 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-503988796\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-503988796 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW29844584 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW29844584 BCX0\">NAMs sind<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW29844584 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW29844584 BCX0\">tierversuchsfreie wissenschaftliche Methoden<\/span><\/span><\/strong><span class=\"TextRun SCXW29844584 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW29844584 BCX0\"><strong>,<\/strong> einschlie\u00dflich aus menschlichen Zellen gewonnener Modelle und KI-gest\u00fctzter Analysen, die zur Generierung von Evidenz f\u00fcr die Arzneimittelentwicklung eingesetzt werden.<\/span><\/span><span class=\"EOP SCXW29844584 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1816113005 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1178739814\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW128671175 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW128671175 BCX0\">Was ist Modul 4 im Marketing?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW128671175 BCX0\">Genehmigung<\/span><span class=\"NormalTextRun SCXW128671175 BCX0\">\u00a0Anwendung?<\/span><\/span><span class=\"EOP SCXW128671175 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-239501690\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-239501690 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong><span class=\"TextRun MacChromeBold SCXW40790795 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW40790795 BCX0\">Modul 4 <\/span><\/span><\/strong><span class=\"TextRun SCXW40790795 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW40790795 BCX0\">enth\u00e4lt <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW40790795 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW40790795 BCX0\">Berichte aus nichtklinischen Studien<\/span><\/span><\/strong><span class=\"TextRun SCXW40790795 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW40790795 BCX0\"><strong>,<\/strong> einschlie\u00dflich pharmakologischer und toxikologischer Daten, die zur Unterst\u00fctzung der Sicherheit eines Arzneimittels verwendet werden.<\/span><\/span><span class=\"EOP SCXW40790795 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1178739814 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-695255088\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW106275594 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW106275594 BCX0\">Wann tritt das MHRA-Vorabpr\u00fcfungsprogramm f\u00fcr Modul 4 in Kraft?<\/span><\/span><span class=\"EOP SCXW106275594 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-428432110\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-428432110 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW170672751 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW170672751 BCX0\">Das System soll voraussichtlich bis zum [Datum einf\u00fcgen] betriebsbereit sein.\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW170672751 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW170672751 BCX0\">Ende\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW170672751 BCX0\">2026<\/span><\/span><span class=\"TextRun SCXW170672751 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW170672751 BCX0\">.<\/span><\/span><span class=\"EOP SCXW170672751 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-695255088 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-238568721\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<p><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a>\u00a0hilft Organisationen\u00a0<\/span><b><span data-contrast=\"auto\">sich entwickelnden regulatorischen Anforderungen<\/span><\/b><span data-contrast=\"auto\">, bewerten\u00a0<\/span><b><span data-contrast=\"auto\">Datenverf\u00fcgbarkeit f\u00fcr nicht-tierische Einreichungen<\/span><\/b><span data-contrast=\"auto\">, und optimieren\u00a0<\/span><b><span data-contrast=\"auto\">durchg\u00e4ngige Compliance-Workflows<\/span><\/b><span data-contrast=\"auto\">, wodurch eine effizientere Anwendung von NAMs im Einklang mit den Erwartungen der MHRA erm\u00f6glicht wird.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-933230841\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-933230841 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">RegASK hilft Organisationen\u00a0<\/span><b><span data-contrast=\"auto\">Regulatorische \u00c4nderungen verfolgen, Auswirkungen bewerten und funktions\u00fcbergreifende Aktualisierungen koordinieren<\/span><\/b><span data-contrast=\"auto\">, die eine effiziente Einhaltung sich wandelnder Anforderungen erm\u00f6glicht, wie zum Beispiel\u00a0<\/span><b><span data-contrast=\"auto\">Aktualisierungen der Verpackung, \u00dcberarbeitungen der Packungsbeilage und Implementierung digitaler Beipackzettel<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-238568721 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On March 24, 2026, the Medicines &amp; Healthcare products Regulatory Agency (MHRA) introduced new regulatory principles for human medicines marketing applications that rely on non-animal evidence. This update supports the UK Government\u2019s broader strategy to reduce and replace animal testing and applies to all medicines seeking Marketing Authorisation (MA) in the United Kingdom.<\/p>","protected":false},"author":41,"featured_media":9761,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,35],"tags":[],"class_list":["post-9748","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Sets Regulatory Pathway for Drug Testing<\/title>\n<meta name=\"description\" content=\"UK MHRA sets a new regulatory pathway to phase out animal testing in drug development, 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