{"id":9746,"date":"2026-04-01T10:27:48","date_gmt":"2026-04-01T02:27:48","guid":{"rendered":"https:\/\/regask.com\/?p=9746"},"modified":"2026-04-01T10:27:48","modified_gmt":"2026-04-01T02:27:48","slug":"japan-aktualisiert-die-jpma-checkliste-zur-selbstinspektion-fur-qualitatsprufungen-bei-zulassungsantragen-fur-neue-arzneimittel","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications\/","title":{"rendered":"Japan aktualisiert JPMA-Checkliste f\u00fcr Selbstinspektionen zur Qualit\u00e4tssicherung\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">An\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">26. M\u00e4rz 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\"><strong>,<\/strong> Die<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">Japanischer Verband der Pharmahersteller (JPMA) <\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">ver\u00f6ffentlichte ein <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">\u00fcberarbeitete Checkliste zur Selbstinspektion f\u00fcr Qualit\u00e4tspr\u00fcfungen<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\"><strong>,<\/strong> Einf\u00fchrung eines aktualisierten Rahmens zur Unterst\u00fctzung der\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">Zuverl\u00e4ssigkeit und wissenschaftliche Validit\u00e4t von pharmazeutischen Qualit\u00e4tsdaten<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><strong><span class=\"NormalTextRun SCXW31536731 BCX0\">\u00a0<\/span><\/strong><span class=\"NormalTextRun SCXW31536731 BCX0\">eingereicht<\/span><span class=\"NormalTextRun SCXW31536731 BCX0\">\u00a0bei Neuzulassungsantr\u00e4gen f\u00fcr Arzneimittel in Japan.<\/span><\/span><span class=\"EOP SCXW31536731 BCX0\" 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-5208433\">\n\n\t<div id=\"col-1544677674\" 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-1251322554\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1251322554 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-622912946\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-622912946 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die aktualisierte Checkliste ersetzt die vorherige\u00a0<\/span><b><span data-contrast=\"auto\">Checkliste f\u00fcr die dokumentenbasierte Konformit\u00e4tspr\u00fcfung<\/span><\/b><span data-contrast=\"auto\">\u00a0und konsolidiert\u00a0<\/span><b><span data-contrast=\"auto\">Analytische Pr\u00fcfungen und Stabilit\u00e4tspr\u00fcfungen in einem einzigen einheitlichen Rahmen<\/span><\/b><span data-contrast=\"auto\">. Diese Integration soll die Art und Weise vereinfachen, wie Antragsteller die Zuverl\u00e4ssigkeit qualitativ hochwertiger Daten in regulatorischen Einreichungen bewerten und nachweisen k\u00f6nnen.<\/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 \u00dcberarbeitung entfernt ausdr\u00fccklich\u00a0<\/span><b><span data-contrast=\"auto\">nicht-klinische Studienelemente<\/span><\/b><span data-contrast=\"auto\">, Dadurch wird der Umfang der Checkliste eingeschr\u00e4nkt, um sich auf die f\u00fcr die Produktzulassung relevanten Qualit\u00e4tspr\u00fcfungen zu konzentrieren. Au\u00dferdem wird klargestellt, dass die Checkliste\u00a0<\/span><b><span data-contrast=\"auto\">keine verbindliche Liste der erforderlichen Dokumente<\/span><\/b><span data-contrast=\"auto\">, sondern vielmehr ein Werkzeug zur Unterst\u00fctzung\u00a0<\/span><b><span data-contrast=\"auto\">Gesamtzuverl\u00e4ssigkeitsbewertung<\/span><\/b><span data-contrast=\"auto\">\u00a0der eingereichten Daten.<\/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 betont die Checkliste, dass die Bewerber sicherstellen m\u00fcssen, dass\u00a0<\/span><b><span data-contrast=\"auto\">Vorbereitung, Durchf\u00fchrung und Dokumentation von Tests<\/span><\/b><span data-contrast=\"auto\">\u00a0die festgelegten Zuverl\u00e4ssigkeitsstandards erf\u00fcllen. F\u00fcr\u00a0<\/span><b><span data-contrast=\"auto\">vertraglich vereinbarte Tests<\/span><\/b><span data-contrast=\"auto\">, Bewerber sind verpflichtet, folgende Voraussetzungen zu erf\u00fcllen:\u00a0<\/span><b><span data-contrast=\"auto\">dokumentierte Methoden zur Best\u00e4tigung der Testzuverl\u00e4ssigkeit<\/span><\/b><span data-contrast=\"auto\">, wodurch die Verantwortlichkeit auch bei Outsourcing gest\u00e4rkt 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<p><span data-contrast=\"auto\">Das Update unterstreicht zudem die Bedeutung von\u00a0<\/span><b><span data-contrast=\"auto\">Einhaltung der Vorschriften f\u00fcr elektronische Aufzeichnungen<\/span><\/b><span data-contrast=\"auto\">, die die Einhaltung festgelegter Verfahren erfordert, einschlie\u00dflich derjenigen, die mit\u00a0<\/span><b><span data-contrast=\"auto\">Richtlinien f\u00fcr elektronische Aufzeichnungen und elektronische Signaturen<\/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\">Der\u00a0<\/span><b><span data-contrast=\"auto\">JPMA<\/span><\/b><span data-contrast=\"auto\">\u00a0stellt fest, dass\u00a0<\/span><b><span data-contrast=\"auto\">Laufende \u00dcberarbeitungen werden erwartet<\/span><\/b><span data-contrast=\"auto\">\u00a0da sich die Branchenpraktiken st\u00e4ndig weiterentwickeln.<\/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-1544677674 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1340108430\" 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-1048911873\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1048911873 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">Dieses Update verbessert<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">regulatorische Klarheit<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\"><strong>\u00a0<\/strong>von\u00a0<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">Konsolidierung<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0Die Erwartungen an Qualit\u00e4tstests werden in einem einzigen Rahmenwerk zusammengefasst und irrelevante Elemente entfernt. Es unterst\u00fctzt\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">digitale Ausrichtung<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0durch klarere Erwartungen an elektronische Aufzeichnungen und verbessert\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">Betriebseffizienz<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0durch Vereinfachung der Selbstinspektionsprozesse. Gleichzeitig wird es\u00a0<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">unterh\u00e4lt<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0a\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">nicht-pr\u00e4skriptiver Ansatz<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\"><strong>,<\/strong> Minimierung unn\u00f6tiger Compliance-Aufw\u00e4nde bei gleichzeitiger Gew\u00e4hrleistung der Datenzuverl\u00e4ssigkeit.<\/span><\/span><span class=\"EOP SCXW96147886 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-1340108430 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-987530629\" 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-1372961289\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1372961289 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update ist relevant f\u00fcr<strong> Qualit\u00e4tssicherung (QS), Zulassungsangelegenheiten (RA) und F&amp;E-Teams<\/strong> innerhalb von Pharmaunternehmen, die sich vorbereiten<strong> Neuzulassungsantr\u00e4ge f\u00fcr Arzneimittel in Japan,<\/strong> insbesondere diejenigen, die beteiligt sind <strong>Qualit\u00e4tspr\u00fcfung, Datenintegrit\u00e4t und Einreichungsbereitschaft. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-987530629 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1080772965\" 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-907803089\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-907803089 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Organisationen sollten\u00a0<\/span><b><span data-contrast=\"auto\">\u00dcberpr\u00fcfung und Aktualisierung der internen Qualit\u00e4tspr\u00fcfungsverfahren und Selbstinspektionspraktiken<\/span><\/b><span data-contrast=\"auto\">\u00a0um sich an die \u00fcberarbeitete Checkliste anzupassen. Teams sollten au\u00dferdem\u00a0<\/span><b><span data-contrast=\"auto\">aktuelle Dokumentations-Workflows bewerten<\/span><\/b><span data-contrast=\"auto\">\u00a0um sicherzustellen, dass\u00a0<\/span><b><span data-contrast=\"auto\">Standards f\u00fcr wissenschaftliche G\u00fcltigkeit, Datenintegrit\u00e4t und Zuverl\u00e4ssigkeit<\/span><\/b><span data-contrast=\"auto\">\u00a0Die Anforderungen werden durchg\u00e4ngig erf\u00fcllt. Eine funktions\u00fcbergreifende Koordination zwischen Qualit\u00e4tssicherung, Zulassungsabteilung und Forschung &amp; Entwicklung ist unerl\u00e4sslich, um die vollst\u00e4ndige \u00dcbereinstimmung mit dem aktualisierten Rahmenwerk sicherzustellen.<\/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 Anforderungen an Datenzuverl\u00e4ssigkeit und digitale Compliance st\u00e4ndig weiterentwickeln, sind L\u00f6sungen wie\u00a0<\/span><b><span data-contrast=\"auto\">RegASK<\/span><\/b><span data-contrast=\"auto\">\u00a0k\u00f6nnen Organisationen dabei unterst\u00fctzen, wettbewerbsf\u00e4hig zu bleiben.\u00a0<a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a>\u00a0ist 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,\u00a0<a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a>\u00a0liefert zeitnahe, vorausschauende und umsetzbare Erkenntnisse sowie eine durchg\u00e4ngige Automatisierung, optimiert Compliance-Prozesse, mindert Risiken und beschleunigt den Marktzugang in mehr als 160 L\u00e4ndern. <strong><a href=\"http:\/\/regask.com\/de\/\">Mehr erfahren<\/a> oder <a href=\"https:\/\/regask.com\/de\/demo-buchen\/\">Jetzt Demo buchen.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1080772965 > .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-1145564101\">\n\n\t<div id=\"col-467515064\" 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-2015840326\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2015840326 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW96186529 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96186529 BCX0\">Was ist die JPMA-Checkliste zur Selbstinspektion f\u00fcr Qualit\u00e4tspr\u00fcfungen?<\/span><\/span><span class=\"EOP SCXW96186529 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-423684077\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-423684077 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es handelt sich um ein von der <strong>Japanischer Verband der Pharmahersteller (JPMA)<\/strong> um den Bewerbern bei der Beurteilung zu helfen <strong>Zuverl\u00e4ssigkeit und wissenschaftliche Validit\u00e4t von Qualit\u00e4tspr\u00fcfdaten<\/strong> eingereicht in Zulassungsantr\u00e4gen f\u00fcr neue Arzneimittel.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-467515064 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-935153616\" 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 SCXW249529551 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW249529551 BCX0\">Was sind die wichtigsten Neuerungen in der \u00fcberarbeiteten Checkliste?<\/span><\/span><span class=\"EOP SCXW249529551 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-1721423289\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1721423289 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">Die Checkliste jetzt\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">integriert analytische und Stabilit\u00e4tspr\u00fcfungen<\/span><\/span><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">, entfernt\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">nicht-klinische Studienelemente<\/span><\/span><\/strong><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\"><strong>,<\/strong> und betont\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">Datenzuverl\u00e4ssigkeit, Dokumentationsstandards und Einhaltung der Vorschriften f\u00fcr elektronische Aufzeichnungen<\/span><\/span><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">.<\/span><\/span><span class=\"EOP SCXW114960211 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-935153616 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1101510177\" 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 SCXW39145630 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW39145630 BCX0\">Sind in der Checkliste die erforderlichen Einreichungsunterlagen aufgef\u00fchrt?<\/span><\/span><span class=\"EOP SCXW39145630 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-524911609\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-524911609 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">Nein. Die Checkliste ist\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">nicht vorschreibend<\/span><\/span><\/strong><span class=\"TextRun SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">\u00a0und definiert keine feste Liste erforderlicher Dokumente. Es soll unterst\u00fctzen\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">Gesamtzuverl\u00e4ssigkeitsbewertung<\/span><\/span><span class=\"TextRun SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">.<\/span><\/span><span class=\"EOP SCXW45445511 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-1101510177 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-638985427\" 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 SCXW241486931 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW241486931 BCX0\">Wie kann\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW241486931 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW241486931 BCX0\">\u00a0Hilfe bei der Einhaltung der Vorschriften im Rahmen dieses Updates?<\/span><\/span><span class=\"EOP SCXW241486931 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-1516869843\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1516869843 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a>\u00a0hilft Organisationen dabei, sich entwickelnde regulatorische Erwartungen zu \u00fcberwachen.,\u00a0<\/span><b><span data-contrast=\"auto\">Angleichung interner Prozesse an aktualisierte Rahmenbedingungen<\/span><\/b><span data-contrast=\"auto\">und stellen Sie sicher\u00a0<\/span><b><span data-contrast=\"auto\">Datenintegrit\u00e4t und Einreichungsbereitschaft<\/span><\/b><span data-contrast=\"auto\">\u00a0durch KI-gest\u00fctzte regulatorische Analysen und Workflow-Automatisierung.<\/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-638985427 > .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 26, 2026, the\u00a0Japan Pharmaceutical Manufacturers Association (JPMA) published a revised self-inspection checklist for quality testing, introducing an updated framework to support the\u00a0reliability and scientific validity of pharmaceutical quality data\u00a0submitted\u00a0in new drug applications in Japan.\u00a0<\/p>","protected":false},"author":41,"featured_media":9747,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,35,519],"tags":[],"class_list":["post-9746","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-pharma-biotech-latest-insights","category-japan-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Japan Updates JPMA Self-Inspection Checklist for Quality Testing in New Drug Applications<\/title>\n<meta name=\"description\" content=\"Japan\u2019s JPMA has updated its self-inspection checklist for quality testing in new drug applications, integrating analytical and stability testing to improve data reliability.\" \/>\n<meta name=\"robots\" content=\"index, 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