{"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-1522921500\">\n\n\t<div id=\"col-1921959802\" 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-1825021274\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1825021274 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-224104962\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-224104962 {\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-1921959802 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1964706351\" 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-683210017\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-683210017 {\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-1964706351 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1161293700\" 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-1105546661\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1105546661 {\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-1161293700 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-320589824\" 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-1063532505\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1063532505 {\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-320589824 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-536537988\" 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-1363944958\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1363944958 {\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-536537988 > .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-1639763191\">\n\n\t<div id=\"col-491843108\" 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-1294382398\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1294382398 {\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-1255344371\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1255344371 {\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-491843108 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1166965925\" 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-2076001067\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2076001067 {\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-1166965925 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-631638103\" 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-663207452\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-663207452 {\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-631638103 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-869787459\" 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-1430465472\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1430465472 {\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-869787459 > .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 3, 2026, the\u00a0U.S. Food and Drug Administration (FDA)\u00a0announced a public consultation requesting comments on its\u00a0Scale-Up and\u00a0Postapproval\u00a0Changes (SUPAC)\u00a0guidances\u00a0for pharmaceutical products. The consultation focuses on\u00a0chemistry, manufacturing, and controls (CMC)\u00a0requirements and aims to evaluate whether existing SUPAC guidance documents\u00a0remain\u00a0relevant and aligned with current scientific and regulatory standards.\u00a0 The review covers SUPAC\u00a0guidances\u00a0for\u00a0immediate release,\u00a0modified release, and\u00a0nonsterile semisolid dosage forms,&#8230;<\/p>","protected":false},"author":41,"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 v27.3 (Yoast SEO v27.5) - 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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=\"Shaffa Renaningtyas\" \/>\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=\"Shaffa Renaningtyas\" \/>\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\":\"Shaffa 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