{"id":9628,"date":"2026-03-11T15:24:15","date_gmt":"2026-03-11T07:24:15","guid":{"rendered":"https:\/\/regask.com\/?p=9628"},"modified":"2026-03-11T15:24:15","modified_gmt":"2026-03-11T07:24:15","slug":"die-britische-arzneimittelbehorde-mhra-veroffentlicht-leitlinien-zur-behordlichen-zulassung-von-im-weltraum-hergestellten-arzneimitteln","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/uk-mhra-issues-guidance-on-regulatory-approval-for-space-manufactured-pharmaceuticals\/","title":{"rendered":"Die britische Arzneimittelbeh\u00f6rde MHRA ver\u00f6ffentlicht Leitlinien zur beh\u00f6rdlichen Zulassung f\u00fcr Weltraumtechnologien\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">An\u00a0<\/span><b><span data-contrast=\"auto\">5. M\u00e4rz 2026<\/span><\/b><span data-contrast=\"auto\">, Die britische Arzneimittel- und Medizinproduktebeh\u00f6rde (MHRA) hat zusammen mit der britischen Raumfahrtagentur, dem B\u00fcro f\u00fcr regulatorische Innovation (RIO) und der Zivilluftfahrtbeh\u00f6rde (CAA) neue Ma\u00dfnahmen angek\u00fcndigt.\u00a0<\/span><b><span data-contrast=\"auto\">regulatorische Leitlinien f\u00fcr im Weltraum hergestellte Arzneimittel<\/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<p><span data-contrast=\"auto\">Die Initiative beschreibt, wie bestehende\u00a0<\/span><b><span data-contrast=\"auto\">Regulierungsrahmen f\u00fcr Arzneimittel und Raumfahrt im Vereinigten K\u00f6nigreich<\/span><\/b><span data-contrast=\"auto\">\u00a0kann f\u00fcr Arzneimittel gelten, die in\u00a0<\/span><b><span data-contrast=\"auto\">Mikrogravitationsumgebungen<\/span><\/b><span data-contrast=\"auto\">, Dies betrifft insbesondere Biologika und andere komplexe Therapien. Die Leitlinien sollen Unternehmen bei der Entwicklung weltraumgest\u00fctzter pharmazeutischer Produktionsmethoden unterst\u00fctzen und gleichzeitig die regulatorischen Anforderungen f\u00fcr die Zulassung und den Marktzugang im Vereinigten K\u00f6nigreich pr\u00e4zisieren.<\/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<div class=\"row\"  id=\"row-776191425\">\n\n\t<div id=\"col-442272356\" 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-1772881390\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1772881390 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-486976553\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-486976553 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die neu eingef\u00fchrten Richtlinien erkl\u00e4ren, wie\u00a0<\/span><b><span data-contrast=\"auto\">Die bestehenden britischen Arzneimittelvorschriften gelten auch f\u00fcr Arzneimittel, die im Orbit mithilfe von Mikrogravitationsplattformen hergestellt werden.<\/span><\/b><span data-contrast=\"auto\">. Das Rahmenwerk hilft Unternehmen, die regulatorischen Erwartungen an die Produktentwicklung, die Fertigungsstandards und die letztendliche Marktzulassung zu verstehen.<\/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\">Dar\u00fcber hinaus werden die Regulierungsbeh\u00f6rden eine\u00a0<\/span><b><span data-contrast=\"auto\">Regulierungs-Sandbox f\u00fcr die Wiedereingliederung<\/span><\/b><span data-contrast=\"auto\">, Diese Testumgebung wurde entwickelt, um Unternehmen bei der Erprobung regulatorischer Ans\u00e4tze f\u00fcr die sichere R\u00fcckf\u00fchrung von im Weltraum hergestellten Produkten zur Erde zu unterst\u00fctzen. Sie erm\u00f6glicht es Aufsichtsbeh\u00f6rden und Branchenvertretern, betriebliche, sicherheitsrelevante und konformit\u00e4tsbezogene Aspekte im Zusammenhang mit dem Wiedereintritt und der Produkthandhabung zu bewerten.<\/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 das Branchenverst\u00e4ndnis weiter zu f\u00f6rdern, werden die Beh\u00f6rden ver\u00f6ffentlichen\u00a0<\/span><b><span data-contrast=\"auto\">Prinzipienbasierte Fallstudien<\/span><\/b><span data-contrast=\"auto\">\u00a0Die Beispiele veranschaulichen m\u00f6gliche regulatorische Wege f\u00fcr die pharmazeutische Produktion im Weltraum. Sie sollen Organisationen dabei helfen zu bewerten, wie bestehende Vorschriften auf verschiedene Produktionsszenarien in Mikrogravitationsumgebungen anwendbar sind.<\/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 Initiative betont au\u00dferdem\u00a0<\/span><b><span data-contrast=\"auto\">fr\u00fchzeitige Einbindung der wissenschaftlichen und regulatorischen Beratungsdienste der MHRA<\/span><\/b><span data-contrast=\"auto\">, und ermutigt Unternehmen, sich w\u00e4hrend der Entwicklungsplanung mit den Regulierungsbeh\u00f6rden abzustimmen, um die geltenden regulatorischen Anforderungen besser zu verstehen.<\/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\">Abschlie\u00dfend hebt das Programm die Bedeutung von hervor\u00a0<\/span><b><span data-contrast=\"auto\">St\u00e4rkung der Zusammenarbeit entlang der gesamten Lieferkette f\u00fcr Pharmazeutika und Raumfahrttechnologie<\/span><\/b><span data-contrast=\"auto\">, wodurch die langfristige Kommerzialisierung von im Weltraum hergestellten Medikamenten erleichtert 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\t<\/div>\n\t\t\t\t\n<style>\n#col-442272356 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1661123516\" 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-1884423765\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1884423765 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">Diese regulatorische Initiative sieht Folgendes vor\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\"><strong>Mehr Klarheit dar\u00fcber, wie die bestehenden britischen Arzneimittel- und Raumfahrtvorschriften auf in Mikrogravitationsumgebungen hergestellte Arzneimittel Anwendung finden.<\/strong><\/span><\/span><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\"><strong>.<\/strong> Von\u00a0<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">Festlegung<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u00a0Leitlinien, Fallstudien und ein regulatorischer Testraum \u2013 der Rahmen unterst\u00fctzt Innovationen, w\u00e4hrend\u00a0<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">Aufrechterhaltung<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u00a0Regulierungsaufsicht. Sie f\u00f6rdert auch<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">Regulatorische Angleichung, verbesserte Entwicklungsplanung und effiziente Wege f\u00fcr neue, weltraumgest\u00fctzte Lebenswissenschaftstechnologien<\/span><\/span><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">.<\/span><\/span><span class=\"EOP SCXW10975365 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-1661123516 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-657976751\" 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>F\u00fcr wen ist das relevant?<\/h2>\n\t<div id=\"gap-1841610661\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1841610661 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">Die Leitlinien sind insbesondere relevant f\u00fcr\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">Pharmahersteller, Biotechnologieunternehmen und Anbieter von Mikrogravitationsplattformen<\/span><\/span><\/strong><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0die Entwicklung von\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">Biologika, neuartige Therapien und andere komplexe Arzneimittel<\/span><\/span><\/strong><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0das mag\u00a0<\/span><span class=\"NormalTextRun SCXW248171813 BCX0\">Nutzen<\/span><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0aus Produktionsumgebungen unter Mikrogravitation.<\/span><\/span><span class=\"EOP SCXW248171813 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-657976751 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-219766042\" 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-1001060848\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1001060848 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Organisationen, die beteiligt sind\u00a0<\/span><b><span data-contrast=\"auto\">weltraumgest\u00fctzte pharmazeutische Fertigung<\/span><\/b><span data-contrast=\"auto\">\u00a0sollte die skizzierten regulatorischen Ans\u00e4tze \u00fcberpr\u00fcfen und beurteilen, ob aktuelle oder geplante Initiativen mit dem neuen Rahmenwerk \u00fcbereinstimmen.<\/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\">Unternehmen, die solche Technologien entwickeln, werden dazu ermutigt\u00a0<\/span><b><span data-contrast=\"auto\">Nehmen Sie fr\u00fchzeitig die wissenschaftlichen und regulatorischen Beratungsdienste der MHRA in Anspruch.<\/span><\/b><span data-contrast=\"auto\">\u00a0um die anwendbaren regulatorischen Wege, Entwicklungs\u00fcberlegungen und Compliance-Anforderungen besser zu verstehen.<\/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 Rahmenbedingungen weiterentwickeln, um neue Technologien wie die weltraumgest\u00fctzte Fertigung zu unterst\u00fctzen, m\u00fcssen die Regulierungsteams stets \u00fcber neue Richtlinien und branchen\u00fcbergreifende politische Entwicklungen informiert sein.\u00a0<a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a>\u00a0ist ein f\u00fchrender\u00a0<\/span><b><span data-contrast=\"auto\">Agentic AI-Plattform f\u00fcr regulatorische Intelligenz und Workflow-Orchestrierung<\/span><\/b><span data-contrast=\"auto\">\u00a0Das System erm\u00f6glicht es globalen Organisationen in stark regulierten Branchen, darunter Konsumg\u00fcter und Biowissenschaften, sich proaktiv in komplexen regulatorischen Umfeldern zu bewegen. Durch die Kombination fortschrittlicher Technologien\u00a0<\/span><b><span data-contrast=\"auto\">Agentische KI mit Experten im Netzwerk<\/span><\/b><span data-contrast=\"auto\">,\u00a0<a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/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.\u00a0<\/span><b><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/de\/\">Mehr erfahren<\/a> oder <a href=\"https:\/\/regask.com\/de\/demo-buchen\/\">Jetzt Demo buchen.<\/a><\/span><\/b><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-219766042 > .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-1784437352\">\n\n\t<div id=\"col-352912044\" 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-1564779029\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1564779029 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW283686 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW283686 BCX0\">Welche Richtlinien gibt die MHRA f\u00fcr im Weltraum hergestellte Arzneimittel?<\/span><\/span><span class=\"EOP SCXW283686 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-1255432502\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1255432502 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\">Die Leitlinien verdeutlichen, wie die bestehenden britischen Regulierungsrahmen f\u00fcr Arzneimittel und Raumfahrt auf in Gro\u00dfbritannien hergestellte Arzneimittel Anwendung finden.\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\">Mikrogravitationsumgebungen<\/span><\/span><\/strong><span class=\"TextRun SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\"><strong>,<\/strong> einschlie\u00dflich Entwicklung, Einbindung der Regulierungsbeh\u00f6rden und R\u00fcckf\u00fchrung des Produkts zur Erde.<\/span><\/span><span class=\"EOP SCXW68796879 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-352912044 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-135671490\" 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 SCXW90362748 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW90362748 BCX0\">Was ist der Re-entry Regulatory Sandbox?<\/span><\/span><span class=\"EOP SCXW90362748 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-1566150196\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1566150196 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">Der\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">Regulierungs-Sandbox f\u00fcr die Wiedereingliederung<\/span><\/span><\/strong><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\"><strong>\u00a0<\/strong>ist eine regulatorische Testumgebung, die Unternehmen bei der Bewertung von Ans\u00e4tzen f\u00fcr eine sichere R\u00fcckkehr unterst\u00fctzen soll.<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">im Weltraum hergestellte pharmazeutische Produkte<\/span><\/span><\/strong><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">\u00a0vom Orbit zur Erde.<\/span><\/span><span class=\"EOP SCXW250166262 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-135671490 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-553126034\" 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 SCXW14021316 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW14021316 BCX0\">Welche Arten von Medikamenten sind f\u00fcr die Herstellung unter Mikrogravitation am relevantesten?<\/span><\/span><span class=\"EOP SCXW14021316 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-1831406075\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1831406075 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW88875603 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88875603 BCX0\">Die Initiative hebt hervor\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW88875603 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88875603 BCX0\">Biologika, neuartige Therapien und andere komplexe Arzneimittel<\/span><\/span><\/strong><span class=\"TextRun SCXW88875603 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88875603 BCX0\">\u00a0als Bereiche, die m\u00f6glicherweise\u00a0<\/span><span class=\"NormalTextRun SCXW88875603 BCX0\">Nutzen<\/span><span class=\"NormalTextRun SCXW88875603 BCX0\">\u00a0aus Fertigungsprozessen, die in Mikrogravitationsumgebungen durchgef\u00fchrt werden.<\/span><\/span><span class=\"EOP SCXW88875603 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-553126034 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2040242880\" 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 dabei helfen, regulatorische Aktualisierungen im Zusammenhang mit S\u00e4uglingsnahrung zu \u00fcberwachen?<\/h4>\n\t<div id=\"gap-1077431780\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1077431780 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW88416556 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/de\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW88416556 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW88416556 BCX0\">\u00a0unterst\u00fctzt Regulierungs- und Compliance-Teams\u00a0<\/span><span class=\"NormalTextRun SCXW88416556 BCX0\">Monitor<\/span><span class=\"NormalTextRun SCXW88416556 BCX0\">\u00a0sich entwickelnde globale Vorschriften, Bewertung der regulatorischen Auswirkungen und Verwaltung von Compliance-Workflows \u00fcber alle Bereiche hinweg\u00a0<\/span><span class=\"NormalTextRun SCXW88416556 BCX0\">Gerichtsbarkeiten<\/span><span class=\"NormalTextRun SCXW88416556 BCX0\">, wodurch Organisationen in die Lage versetzt werden, informiert und vorbereitet zu bleiben.\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW88416556 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88416556 BCX0\">neue regulatorische Wege f\u00fcr aufstrebende Technologien<\/span><\/span><\/strong><span class=\"TextRun SCXW88416556 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88416556 BCX0\">\u00a0werden vorgestellt.<\/span><\/span><span class=\"EOP SCXW88416556 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-2040242880 > .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\u00a0March 5, 2026, the Medicines and Healthcare products Regulatory Agency (MHRA), together with the UK Space Agency, the Regulatory Innovation Office (RIO), and the Civil Aviation Authority (CAA), announced new\u00a0regulatory guidance for pharmaceuticals manufactured in space.\u00a0 The initiative outlines how existing\u00a0UK medicines and spaceflight regulatory frameworks\u00a0may apply to medicines produced in\u00a0microgravity environments, particularly biologics and&#8230;<\/p>","protected":false},"author":41,"featured_media":9629,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,35],"tags":[],"class_list":["post-9628","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 v27.5 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Issues Guidance on Regulatory Approval<\/title>\n<meta name=\"description\" content=\"Explore the UK MHRA guidance on 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