{"id":9716,"date":"2026-03-25T17:04:10","date_gmt":"2026-03-25T09:04:10","guid":{"rendered":"https:\/\/regask.com\/?p=9716"},"modified":"2026-03-25T17:04:56","modified_gmt":"2026-03-25T09:04:56","slug":"mhra-und-nice-haben-ein-aufeinander-abgestimmtes-zulassungs-und-hta-verfahren-eingefuhrt-um-den-zugang-zu-arzneimitteln-in-england-zu-beschleunigen","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/mhra-and-nice-launch-aligned-licensing-and-hta-process-to-accelerate-access-to-medicines-in-england\/","title":{"rendered":"MHRA und NICE f\u00fchren einheitliches Zulassungs- und HTA-Verfahren ein\u2026"},"content":{"rendered":"<p>An <strong>17. M\u00e4rz 2026<\/strong>, Die <strong>Arzneimittel- und Medizinproduktebeh\u00f6rde (MHRA)<\/strong> und die <strong>Nationales Institut f\u00fcr Exzellenz in Gesundheit und Pflege (NICE)<\/strong> k\u00fcndigte ein neues <strong>gemeinsamer Prozess<\/strong> das \u00fcbereinstimmt <strong>beh\u00f6rdliche Genehmigungen<\/strong> mit <strong>Bewertung von Gesundheitstechnologien (HTA)<\/strong> f\u00fcr Arzneimittel in England. Start am <strong>1. April 2026<\/strong>, Dieser Ansatz ist darauf ausgelegt, <strong>den Patientenzugang zu neuen Medikamenten um drei bis sechs Monate beschleunigen<\/strong> durch synchronisierte Pr\u00fcfverfahren.<\/p>\n<div class=\"row\"  id=\"row-1377759974\">\n\n\t<div id=\"col-1396270101\" 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-1257668427\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1257668427 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-8226075\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-8226075 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Das neue Verfahren f\u00fchrt ein <strong>Paralleles \u00dcberpr\u00fcfungsmodell<\/strong>, wodurch erm\u00f6glicht wird <strong>MHRA-Lizenzierungsentscheidungen<\/strong> Und <strong>NICE-Bewertungen von Gesundheitstechnologien<\/strong> Die Zulassung neuer Arzneimittel soll gleichzeitig erfolgen. Dieser koordinierte Ansatz soll die Verz\u00f6gerungen zwischen beh\u00f6rdlicher Zulassung und Erstattungsentscheidung verringern.<\/p>\n<p>Ein wesentlicher Bestandteil der Initiative ist die <strong>Integrierter wissenschaftlicher Beratungsdienst<\/strong>, das eine <strong>Einzelzugangspunkt<\/strong> damit Pharmaunternehmen erhalten <strong>koordinierte F\u00fchrung<\/strong> in Bezug auf regulatorische Anforderungen und die Generierung von Nachweisen. Dies zielt darauf ab, die \u00dcbereinstimmung zwischen klinischen Entwicklungsstrategien und den Erwartungen an die regulatorischen Vorgaben sowie an die Wertbewertung sicherzustellen.<\/p>\n<p>Das Verfahren gilt insbesondere f\u00fcr <strong>Pharmazeutische Produkte, die in England auf den Markt kommen wollen<\/strong>, w\u00e4hrend <strong>Medizinprodukte sind nicht enthalten.<\/strong> in dieser ersten Phase der Einf\u00fchrung. Die Teilnahme beginnt unter einem <strong>Fr\u00fchzugangsphase<\/strong>, mit dem <strong>Erste Ergebnisse werden ab Juni 2026 erwartet.<\/strong> f\u00fcr Produkte, die sich derzeit in der Entwicklung oder in der \u00dcberpr\u00fcfung befinden.<\/p>\n<p>Weitere Details k\u00f6nnen die Beteiligten \u00fcber ein <strong>Ein spezielles Webinar ist f\u00fcr den 25. M\u00e4rz 2026 geplant.<\/strong>, wodurch zus\u00e4tzliche Klarheit hinsichtlich der Umsetzung und der betrieblichen Abl\u00e4ufe geschaffen wird.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1396270101 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1265301710\" 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>Datum des Inkrafttretens<\/h2>\n\t<div id=\"gap-919438979\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-919438979 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Der abgestimmte MHRA-NICE-Prozess wird ab sofort implementiert. <strong>1. April 2026<\/strong>, wobei erste Ergebnisse erwartet werden von <strong>Juni 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1265301710 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-768390361\" 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-1357142472\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1357142472 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update verbessert <strong>Regulierungseffizienz<\/strong> durch die Angleichung der Genehmigungs- und Erstattungswege, die Reduzierung von Doppelarbeit und die Verbesserung der Koordination zwischen den Beh\u00f6rden. Es unterst\u00fctzt <strong>schnellere Entscheidungsfindung<\/strong> und f\u00f6rdert <strong>\u00dcbereinstimmung der Beweise<\/strong> \u00fcber regulatorische und HTA-Anforderungen hinweg, was letztendlich die <strong>schnellerer Patientenzugang<\/strong> unter Beibehaltung strenger Bewertungsstandards.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-768390361 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-912011454\" 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-595204168\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-595204168 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Diese Entwicklung ist relevant f\u00fcr <strong>Regulatorische Angelegenheiten<\/strong>, <strong>Forschung und Entwicklung<\/strong>, <strong>Marktzugang<\/strong>, Und <strong>Teams f\u00fcr Gesundheits\u00f6konomie<\/strong> innerhalb von Pharmaunternehmen, die entwickeln <strong>neue Medikamente f\u00fcr den britischen Markt<\/strong>, insbesondere jene, die in England Antr\u00e4ge auf Genehmigung von Sachverhalten einreichen, die sich im Rahmen der sich entwickelnden regulatorischen und Erstattungsrahmenbedingungen \u00e4ndern.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-912011454 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-961117454\" 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-406609806\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-406609806 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Organisationen sollten <strong>aktuelle Produktpipelines bewerten<\/strong> um die Teilnahmeberechtigung f\u00fcr das abgestimmte Verfahren festzustellen und eine Teilnahme daran in Betracht zu ziehen <strong>Webinar am 25. M\u00e4rz<\/strong> um die betrieblichen Anforderungen zu verstehen. Intern <strong>Einreichungsstrategien, Pl\u00e4ne zur Beweisgenerierung und Dossiervorbereitungsprozesse<\/strong> sollten \u00fcberpr\u00fcft und aktualisiert werden, um sie an die <strong>integrierte MHRA-NICE-Leitlinie<\/strong>.<\/p>\n<p>Da regulatorische Prozesse und Marktzugangswege zunehmend miteinander verkn\u00fcpft werden, ist eine strategische Abstimmung in beiden Bereichen unerl\u00e4sslich f\u00fcr zeitnahe Zulassungen und Erstattungsergebnisse.<\/p>\n<p><a href=\"https:\/\/regask.com\/de\/\">RegASK<\/a> 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 von fortschrittlicher agentenbasierter KI mit Expertenwissen, <a href=\"https:\/\/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. <a href=\"https:\/\/regask.com\/de\/produkt\/\">Mehr erfahren<\/a> oder <a href=\"https:\/\/regask.com\/de\/demo-buchen\/\">Demo buchen<\/a> Jetzt.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-961117454 > .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-445168312\">\n\n\t<div id=\"col-187305705\" 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-718779025\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-718779025 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Was ist der MHRA-NICE-konforme Prozess?<\/h4>\n\t<div id=\"gap-769869703\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-769869703 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>es ist ein <strong>gemeinsamer regulatorischer und HTA-Prozess<\/strong> das erm\u00f6glicht <strong>parallele \u00dcberpr\u00fcfung der Lizenzierung und der Bewertung von Gesundheitstechnologien<\/strong> f\u00fcr neue Arzneimittel in England.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-187305705 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1869778944\" 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>Wann tritt das neue Verfahren in Kraft?<\/h4>\n\t<div id=\"gap-512417350\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-512417350 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Der Prozess wird ab <strong>1. April 2026<\/strong>, wobei erste Ergebnisse erwartet werden von <strong>Juni 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1869778944 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-988596745\" 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>Was ist der integrierte wissenschaftliche Beratungsdienst?<\/h4>\n\t<div id=\"gap-675485917\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-675485917 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>es ist ein <strong>Einzelzugangspunkt<\/strong> das bietet <strong>koordinierte regulatorische und evidenzbasierte Leitlinien<\/strong> zur Unterst\u00fctzung abgestimmter Einreichungen bei MHRA und NICE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-988596745 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-408071736\" 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>Wie kann RegASK Unternehmen im Rahmen dieses neuen Verfahrens unterst\u00fctzen?<\/h4>\n\t<div id=\"gap-1629800241\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1629800241 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/de\/\">RegASK <\/a>hilft Organisationen <strong>regulatorische und HTA-Entwicklungen verfolgen<\/strong>, ausrichten <strong>Nachweis- und Einreichungsstrategien<\/strong>, und optimieren <strong>funktions\u00fcbergreifende Arbeitsabl\u00e4ufe<\/strong>, wodurch eine effizientere Navigation durch synchronisierte Genehmigungsprozesse erm\u00f6glicht wird.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-408071736 > .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 17, 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced a new joint process that aligns regulatory licensing with health technology assessment (HTA) for pharmaceuticals in England. Launching on April 1, 2026, this approach is designed to accelerate patient access to new&#8230;<\/p>","protected":false},"author":32,"featured_media":9717,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,39,35],"tags":[],"class_list":["post-9716","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-medical-devices-insights","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MHRA and NICE Launch Aligned Process for Medicines<\/title>\n<meta name=\"description\" content=\"Discover how the MHRA and NICE aligned licensing and HTA process will transform patient access to new medicines in England.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/mhra-und-nice-haben-ein-aufeinander-abgestimmtes-zulassungs-und-hta-verfahren-eingefuhrt-um-den-zugang-zu-arzneimitteln-in-england-zu-beschleunigen\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MHRA and NICE Launch Aligned Licensing and HTA Process to Accelerate Access to Medicines in England\" \/>\n<meta property=\"og:description\" content=\"Discover how the MHRA and NICE aligned licensing and HTA process will transform patient access to new medicines in England.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/mhra-und-nice-haben-ein-aufeinander-abgestimmtes-zulassungs-und-hta-verfahren-eingefuhrt-um-den-zugang-zu-arzneimitteln-in-england-zu-beschleunigen\/\" \/>\n<meta property=\"og:site_name\" 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