{"id":9630,"date":"2026-03-11T15:38:40","date_gmt":"2026-03-11T07:38:40","guid":{"rendered":"https:\/\/regask.com\/?p=9630"},"modified":"2026-03-11T15:38:40","modified_gmt":"2026-03-11T07:38:40","slug":"die-fda-eroffnet-eine-offentliche-konsultation-zur-aktualisierung-der-supac-leitlinien-fur-anderungen-in-der-arzneimittelherstellung-nach-der-zulassung","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/","title":{"rendered":"FDA er\u00f6ffnet \u00f6ffentliche Konsultation zur Aktualisierung der SUPAC-Leitlinien\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">An\u00a0<\/span><b><span data-contrast=\"auto\">3. M\u00e4rz 2026<\/span><\/b><span data-contrast=\"auto\">, Die\u00a0<\/span><b><span data-contrast=\"auto\">US-amerikanische Food and Drug Administration (FDA)<\/span><\/b><span data-contrast=\"auto\">\u00a0k\u00fcndigte eine \u00f6ffentliche Konsultation an, in der um Stellungnahmen zu seinem\/ihrem Vorhaben gebeten wird\u00a0<\/span><b><span data-contrast=\"auto\">Leitlinien f\u00fcr die Ausweitung und \u00c4nderungen nach der Zulassung (SUPAC)<\/span><\/b><span data-contrast=\"auto\">\u00a0f\u00fcr pharmazeutische Produkte. Die Beratung konzentriert sich auf\u00a0<\/span><b><span data-contrast=\"auto\">Chemie, Herstellung und Kontrollen (CMC)<\/span><\/b><span data-contrast=\"auto\">\u00a0Anforderungen und Ziele sind die Bewertung, ob die bestehenden SUPAC-Leitliniendokumente noch relevant sind und mit den aktuellen wissenschaftlichen und regulatorischen Standards \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\">Die \u00dcberpr\u00fcfung umfasst die SUPAC-Leitlinien f\u00fcr\u00a0<\/span><b><span data-contrast=\"auto\">Sofortige Ver\u00f6ffentlichung<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">modifizierte Version<\/span><\/b><span data-contrast=\"auto\">, Und\u00a0<\/span><b><span data-contrast=\"auto\">nicht sterile halbfeste Darreichungsformen<\/span><\/b><span data-contrast=\"auto\">, sowie \u00c4nderungen im Zusammenhang mit\u00a0<\/span><b><span data-contrast=\"auto\">Fertigungsanlagen<\/span><\/b><span data-contrast=\"auto\">. Interessengruppen aus der gesamten pharmazeutischen Industrie sind eingeladen, Feedback einzureichen, um festzustellen, ob \u00dcberarbeitungen, Klarstellungen oder zus\u00e4tzliche Themen in die aktualisierten Leitlinien aufgenommen werden sollten.<\/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 Konsultationsfrist bleibt bis\u00a0<\/span><b><span data-contrast=\"auto\">1. Juni 2026<\/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<div class=\"row\"  id=\"row-1994431250\">\n\n\t<div id=\"col-414211751\" 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-471824564\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-471824564 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-1827103909\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1827103909 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die FDA bittet um R\u00fcckmeldungen zu\u00a0<\/span><b><span data-contrast=\"auto\">Nutzen, Klarheit und Anwendbarkeit<\/span><\/b><span data-contrast=\"auto\">\u00a0der aktuellen SUPAC-Leitlinien, die sich mit der Produktionsausweitung und \u00c4nderungen nach der Zulassung von Arzneimitteln befassen.<\/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 \u00dcberpr\u00fcfung untersucht insbesondere, ob bestehende Leitf\u00e4den f\u00fcr\u00a0<\/span><b><span data-contrast=\"auto\">Sofortige Ver\u00f6ffentlichung<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">modifizierte Version<\/span><\/b><span data-contrast=\"auto\">, Und\u00a0<\/span><b><span data-contrast=\"auto\">nicht sterile halbfeste Darreichungsformen<\/span><\/b><span data-contrast=\"auto\">\u00a0Die Beh\u00f6rde unterst\u00fctzt weiterhin eine effektive regulatorische Aufsicht \u00fcber CMC-\u00c4nderungen. Sie pr\u00fcft au\u00dferdem Leitlinien zu diesem Thema.\u00a0<\/span><b><span data-contrast=\"auto\">\u00c4nderungen der Produktionsanlagen<\/span><\/b><span data-contrast=\"auto\">, was Auswirkungen auf die Fertigungsprozesse und die Qualit\u00e4tssicherungssysteme haben 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\">Dar\u00fcber hinaus pr\u00fcft die FDA, ob diese Dokumente noch mit neueren internationalen Regulierungsrahmen \u00fcbereinstimmen, insbesondere\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1) zum Qualit\u00e4tsrisikomanagement<\/span><\/b><span data-contrast=\"auto\">\u00a0Und\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12 zum Lebenszyklusmanagement von Arzneimitteln<\/span><\/b><span data-contrast=\"auto\">. Die Beh\u00f6rde ermutigt die Beteiligten, Herausforderungen bei der Auslegung oder Umsetzung der SUPAC-Empfehlungen in ihren jeweiligen Zust\u00e4ndigkeitsbereichen zu identifizieren.\u00a0<\/span><b><span data-contrast=\"auto\">pharmazeutische Qualit\u00e4tssysteme<\/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\">Branchenteilnehmer k\u00f6nnten auch vorschlagen\u00a0<\/span><b><span data-contrast=\"auto\">neue Themen, Aktualisierungen oder \u00dcberarbeitungen<\/span><\/b><span data-contrast=\"auto\">\u00a0Dies k\u00f6nnte die Relevanz der Leitlinien verbessern und gleichzeitig dazu beitragen, die regulatorische Komplexit\u00e4t oder unn\u00f6tige Belastung zu reduzieren.<\/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-414211751 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-25546876\" 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>Feedback-Frist<\/h2>\n\t<div id=\"gap-1339014980\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1339014980 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">Interessengruppen sind eingeladen\u00a0<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">einreichen<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">\u00a0Kommentare zur \u00dcberpr\u00fcfung der SUPAC-Leitlinien der FDA durch\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">1. Juni 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\"><strong>.<\/strong> Einreichungen k\u00f6nnen \u00fcber die\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">von der FDA festgelegte elektronische oder schriftliche Kan\u00e4le.<\/span><\/span><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">.<\/span><\/span><span class=\"EOP SCXW54403655 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-25546876 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-794776793\" 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-77796576\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-77796576 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die SUPAC-Leitlinien spielen eine wichtige Rolle bei der Festlegung der Vorgehensweise von Pharmaherstellern im Umgang mit Arzneimitteln.\u00a0<\/span><b><span data-contrast=\"auto\">\u00c4nderungen der Fertigungs- und Qualit\u00e4tskontrollprozesse nach der Zulassung<\/span><\/b><span data-contrast=\"auto\">. Durch die \u00dcberpr\u00fcfung dieser Dokumente will die FDA sicherstellen, dass sie die folgenden Punkte widerspiegeln:\u00a0<\/span><b><span data-contrast=\"auto\">aktuelle wissenschaftliche Standards, risikobasierte Regulierungsans\u00e4tze und die Angleichung an internationale Rahmenwerke<\/span><\/b><span data-contrast=\"auto\">\u00a0wie zum Beispiel\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1)<\/span><\/b><span data-contrast=\"auto\">\u00a0Und\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12<\/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\">Eine Aktualisierung dieser Leitlinien k\u00f6nnte eine gr\u00f6\u00dfere\u00a0<\/span><b><span data-contrast=\"auto\">regulatorische Klarheit, digitale Ausrichtung der Qualit\u00e4tssysteme und effizientes Lebenszyklusmanagement von Arzneimitteln<\/span><\/b><span data-contrast=\"auto\">, und gleichzeitig unn\u00f6tige regulatorische Belastungen f\u00fcr die Hersteller zu minimieren.<\/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-794776793 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-211230867\" 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-1142084302\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1142084302 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">Diese Konsultation ist besonders relevant f\u00fcr\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">Teams f\u00fcr regulatorische Angelegenheiten, Fachkr\u00e4fte f\u00fcr Qualit\u00e4tssicherung (QS), Spezialisten f\u00fcr Fertigung und CMC sowie F\u00fchrungskr\u00e4fte im Bereich der pharmazeutischen Compliance<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\"><strong>\u00a0<\/strong>verantwortlich f\u00fcr die Leitung\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">Skalierungsaktivit\u00e4ten und\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW159808703 BCX0\">nach der Genehmigung<\/span><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0\u00c4nderungen<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0innerhalb regulierter pharmazeutischer Produktionsumgebungen.<\/span><\/span><span class=\"EOP SCXW159808703 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-211230867 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-740552649\" 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-262987179\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-262987179 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Organisationen sollten ihre aktuellen\u00a0<\/span><b><span data-contrast=\"auto\">interne Verfahren f\u00fcr die Steuerung von Scale-up- und Post-Approval-Fertigungs\u00e4nderungen<\/span><\/b><span data-contrast=\"auto\">\u00a0im Vergleich zu den bestehenden SUPAC-Richtlinien. Die Teams f\u00fcr Regulierung und Qualit\u00e4t sollten pr\u00fcfen, in welchen Bereichen\u00a0<\/span><b><span data-contrast=\"auto\">Klarstellung, Modernisierung oder zus\u00e4tzliche Leitlinien<\/span><\/b><span data-contrast=\"auto\">\u00a0w\u00fcrde die Umsetzung verbessern oder die operative Komplexit\u00e4t verringern.<\/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 k\u00f6nnen auch von einer Koordinierung profitieren\u00a0<\/span><b><span data-contrast=\"auto\">Funktions\u00fcbergreifendes Feedback zwischen den Teams f\u00fcr Zulassung, Qualit\u00e4tssicherung und Fertigung.<\/span><\/b><span data-contrast=\"auto\">\u00a0um eine umfassende Antwort zu entwickeln, bevor Kommentare bei der FDA eingereicht werden, bevor\u00a0<\/span><b><span data-contrast=\"auto\">Frist: 1. Juni 2026<\/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\">Da die regulatorischen Erwartungen rund\u00a0<\/span><b><span data-contrast=\"auto\">CMC-Lebenszyklusmanagement und risikobasierte \u00c4nderungskontrolle<\/span><\/b><span data-contrast=\"auto\">\u00a0Da sich regulatorische Informationen und \u00dcberwachungsinstrumente st\u00e4ndig weiterentwickeln, k\u00f6nnen sie Organisationen dabei helfen, Konsultationen zu verfolgen und potenzielle regulatorische \u00c4nderungen vorherzusehen.<\/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\"><a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> ist eine f\u00fchrende agentenbasierte KI-Plattform f\u00fcr regulatorische Analysen und Workflow-Orchestrierung, die globale Unternehmen in stark regulierten Branchen, darunter Konsumg\u00fcter und Life Sciences, in die Lage versetzt, sich proaktiv in komplexen regulatorischen Umfeldern zu bewegen. Durch die Kombination fortschrittlicher <strong>Agentische KI<\/strong> mit Einbindung von Experten, <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. <a href=\"http:\/\/regask.com\/de\/\"><strong>Mehr erfahren <\/strong><\/a>oder<a href=\"https:\/\/regask.com\/de\/demo-buchen\/\"><strong> Jetzt Demo buchen.<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-740552649 > .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-937338888\">\n\n\t<div id=\"col-1431245131\" 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-1521059903\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1521059903 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW116607224 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">Was fordert die FDA?\u00a0<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">R\u00fcckmeldung<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0in der SUPAC-Konsultation?<\/span><\/span><span class=\"EOP SCXW116607224 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1158493044\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1158493044 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">Die FDA bittet die \u00d6ffentlichkeit um Stellungnahmen zu folgendem Thema:<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">Relevanz, Klarheit und N\u00fctzlichkeit der bestehenden SUPAC\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">Leitlinien<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0diese Adresse\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">Skalierung und\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">nach der Genehmigung<\/span><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0\u00c4nderungen<\/span><\/span><\/strong><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\"><strong>\u00a0<\/strong>f\u00fcr pharmazeutische Produkte, insbesondere im Kontext von\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">Chemie, Herstellung und Kontrollen (CMC)<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">.<\/span><\/span><span class=\"EOP SCXW27174500 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-1431245131 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1958519957\" 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 SCXW185224076 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW185224076 BCX0\" data-ccp-parastyle=\"heading 3\">Welche Kategorien von Arzneimitteln werden im SUPAC-Bericht abgedeckt?<\/span><\/span><span class=\"EOP SCXW185224076 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1579395042\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1579395042 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">Die Konsultation umfasst SUPAC\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW232278638 BCX0\">Leitlinien<\/span><span class=\"NormalTextRun SCXW232278638 BCX0\">\u00a0f\u00fcr\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">Sofortige Ver\u00f6ffentlichung<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">,\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">modifizierte Version<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">, Und\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">nicht sterile halbfeste Darreichungsformen<\/span><\/span><\/strong><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\"><strong>,<\/strong> sowie Leitlinien im Zusammenhang mit\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">\u00c4nderungen der Produktionsanlagen<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">.<\/span><\/span><span class=\"EOP SCXW232278638 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-1958519957 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-649551432\" 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 SCXW132097625 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">Wann ist die Frist f\u00fcr\u00a0<\/span><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">einreichen<\/span><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0Kommentare an die FDA?<\/span><\/span><span class=\"EOP SCXW132097625 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1435486441\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1435486441 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">Die Beteiligten m\u00fcssen\u00a0<\/span><span class=\"NormalTextRun SCXW197707949 BCX0\">einreichen<\/span><span class=\"NormalTextRun SCXW197707949 BCX0\">\u00a0Kommentare zur \u00dcberpr\u00fcfung der SUPAC-Leitlinien von\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">1. Juni 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\"><strong>,<\/strong> unter Verwendung der<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">Die FDA legt elektronische oder schriftliche Einreichungswege fest.<\/span><\/span><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">.<\/span><\/span><span class=\"EOP SCXW197707949 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-649551432 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-463928667\" 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-402389604\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-402389604 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/de\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW67355384 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0unterst\u00fctzt Regulierungs- und Compliance-Teams\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">Monitor<\/span><strong><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0globale regulatorische Aktualisierungen, Analyse potenzieller Auswirkungen und Koordinierung interner Reaktionen<\/span><\/strong><\/span><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0zu Konsultationen und \u00dcberarbeitungen von Leitlinien.\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">agentic KI-gest\u00fctzte Plattform f\u00fcr regulatorische Intelligenz<\/span><\/span><\/strong><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0Erm\u00f6glicht es Organisationen, sich entwickelnde regulatorische Rahmenbedingungen zu verfolgen, Compliance-Risiken zu bewerten und die Zusammenarbeit zwischen den Bereichen Regulierung, Qualit\u00e4t und Fertigung zu optimieren.<\/span><\/span><span class=\"EOP SCXW67355384 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-463928667 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Am 3. M\u00e4rz 2026 k\u00fcndigte die US-amerikanische Arzneimittelbeh\u00f6rde FDA eine \u00f6ffentliche Konsultation zu ihren Leitlinien f\u00fcr Scale-Up und Postapproval Changes (SUPAC) f\u00fcr Arzneimittel an. Im Mittelpunkt der Konsultation stehen die Anforderungen an Chemie, Herstellung und Kontrollen (CMC). Ziel ist es, zu bewerten, ob die bestehenden SUPAC-Leitlinien weiterhin relevant sind und den aktuellen wissenschaftlichen und regulatorischen Standards entsprechen. Die \u00dcberpr\u00fcfung umfasst SUPAC-Leitlinien f\u00fcr Darreichungsformen mit sofortiger Wirkstofffreisetzung, modifizierter Wirkstofffreisetzung und nicht-sterile halbfeste Darreichungsformen\u2026<\/p>","protected":false},"author":43,"featured_media":9631,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.7 (Yoast SEO v28.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Opens Public Consultation on Pharmaceutical Changes<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.\" \/>\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\/die-fda-eroffnet-eine-offentliche-konsultation-zur-aktualisierung-der-supac-leitlinien-fur-anderungen-in-der-arzneimittelherstellung-nach-der-zulassung\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Opens Public Consultation on Updating SUPAC Guidance for Postapproval Pharmaceutical Manufacturing Changes\" \/>\n<meta property=\"og:description\" content=\"Explore the FDA&#039;s public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/die-fda-eroffnet-eine-offentliche-konsultation-zur-aktualisierung-der-supac-leitlinien-fur-anderungen-in-der-arzneimittelherstellung-nach-der-zulassung\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-11T07:38:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Reva Ananda\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Reva Ananda\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"FDA Opens Public Consultation on Updating SUPAC 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