{"id":9582,"date":"2026-03-03T21:42:52","date_gmt":"2026-03-03T13:42:52","guid":{"rendered":"https:\/\/regask.com\/?p=9582"},"modified":"2026-03-03T21:43:42","modified_gmt":"2026-03-03T13:43:42","slug":"die-malaysische-npra-schreibt-die-benennung-von-sachkundigem-personal-fur-die-gmp-konformitat-bei-klinischen-prufprodukten-vor","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","title":{"rendered":"NPRA Malaysia schreibt die Erkl\u00e4rung von sachkundigem Personal vor\u2026"},"content":{"rendered":"<p>An <strong>23. Februar 2026,<\/strong> Die <strong>Nationale Arzneimittelregulierungsbeh\u00f6rde (NPRA)<\/strong> ver\u00f6ffentlichte eine neue Richtlinie im Rahmen der Arzneimittel- und Kosmetikverordnung, die zus\u00e4tzliche Bestimmungen einf\u00fchrt <strong>Gute Herstellungspraxis (GMP)<\/strong> Konformit\u00e4tsanforderungen f\u00fcr <strong>Pr\u00fcfpr\u00e4parate<\/strong> Wird in klinischen Studien in Malaysia verwendet. Die Richtlinie betrifft <strong>Hersteller, Importeure und Sponsoren<\/strong> sich bewerben<strong> Importlizenzen f\u00fcr klinische Studien (CTIL) <\/strong>oder<strong> Ausnahmen von klinischen Studien (CTX) <\/strong>und ist<strong> Mit sofortiger Wirkung. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1965012056\">\n\n\t<div id=\"col-727839428\" 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-695716311\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-695716311 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-1197495588\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1197495588 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Gem\u00e4\u00df der neuen Richtlinie m\u00fcssen Antragsteller eine <strong>Erkl\u00e4rung des bef\u00e4higten Personals<\/strong> als formeller Nachweis der GMP-Konformit\u00e4t, wenn Pr\u00fcfpr\u00e4parate in L\u00e4ndern hergestellt werden, in denen die Beh\u00f6rden keine offiziellen GMP-Zertifikate ausstellen. Dies umfasst auch Produkte, die von <strong>China, die Vereinigten Staaten, die ASEAN-Staaten und andere Regionen<\/strong> ohne GMP-Zertifizierungsrahmen.<\/p>\n<p>Die Erkl\u00e4rung muss best\u00e4tigen, dass die Produktionsaktivit\u00e4ten <strong>entspricht den ICH- oder PIC\/S-GMP-Standards.<\/strong> Es muss auch Folgendes beinhalten <strong>Details zur Pr\u00fcfung<\/strong> durchgef\u00fchrt von qualifiziertem Personal oder, falls keine Audits durchgef\u00fchrt werden, ein <strong>schriftliche Begr\u00fcndung<\/strong> Erl\u00e4uterung der Gr\u00fcnde. Basierend auf den eingereichten Erkl\u00e4rungen, <strong>Produktionsst\u00e4tten k\u00f6nnen einer Inspektion durch die NPRA unterliegen.<\/strong> als Teil des \u00dcberpr\u00fcfungsprozesses.<\/p>\n<p>Alle <strong>neue CTIL- und CTX-Anwendungen<\/strong> Bei Arzneimittelpr\u00fcfungen in betroffenen Regionen m\u00fcssen diese Bestimmungen eingehalten werden.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-727839428 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1028652269\" 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-137535187\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-137535187 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Diese Richtlinie sieht vor <strong>regulatorische Klarheit<\/strong> f\u00fcr Sponsoren klinischer Studien, die Pr\u00fcfpr\u00e4parate aus L\u00e4ndern ohne GMP-Zertifizierung beziehen. Durch die Formalisierung alternativer GMP-Nachweise mittels einer Erkl\u00e4rung \u00fcber sachkundiges Personal unterst\u00fctzt die NPRA <strong>Angleichung der Regulierungsbestimmungen an internationale Standards,<\/strong> verbessert <strong>Effizienz der Aufsicht,<\/strong> und gew\u00e4hrleistet die Einhaltung der Vorschriften bei gleichzeitiger Minimierung verfahrenstechnischer H\u00fcrden f\u00fcr die Genehmigung klinischer Studien.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1028652269 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-619406610\" 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-1636803633\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1636803633 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Das Update ist relevant f\u00fcr <strong>Teams f\u00fcr Zulassungsangelegenheiten, Qualit\u00e4tssicherung, klinische Studien und Compliance,<\/strong> sowie <strong>Hersteller, Importeure und Sponsoren<\/strong> beteiligt an der Einfuhr oder Herstellung von Pr\u00fcfpr\u00e4paraten f\u00fcr klinische Studien in Malaysia.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-619406610 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1262027998\" 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-1379981374\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1379981374 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Die Beteiligten sollten die aktuellen und zuk\u00fcnftigen Entwicklungen \u00fcberpr\u00fcfen. <strong>CTIL und CTX<\/strong> <strong>Anwendungen<\/strong> um Pr\u00fcfpr\u00e4parate zu identifizieren, die aus betroffenen L\u00e4ndern stammen. Die Zulassungsabteilungen sollten sich mit folgenden Abteilungen abstimmen: <strong>Qualit\u00e4tssicherung<\/strong> um die erforderlichen <strong>Erkl\u00e4rung des bef\u00e4higten Personals,<\/strong> Es ist sicherzustellen, dass GMP-\u00c4quivalenzerkl\u00e4rungen, Auditdokumentationen oder schriftliche Begr\u00fcndungen vollst\u00e4ndig sind und den Erwartungen der NPRA entsprechen. Interne Prozesse zur Lieferantenqualifizierung und -dokumentation sollten ebenfalls \u00fcberpr\u00fcft und aktualisiert werden, um die fortlaufende Einhaltung der Vorschriften zu gew\u00e4hrleisten.<\/p>\n<p>Da sich die regulatorischen Anforderungen an Produkte f\u00fcr klinische Studien in den verschiedenen Rechtsordnungen st\u00e4ndig weiterentwickeln., <a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> unterst\u00fctzt Teams dabei, die lokalen GMP-Vorgaben und Einreichungsanforderungen einzuhalten. <a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> ist eine f\u00fchrende agentenbasierte KI-Plattform f\u00fcr regulatorische Intelligenz und Workflow-Orchestrierung, die globale Organisationen in stark regulierten Sektoren, darunter Konsumg\u00fcter und Biowissenschaften, in die Lage versetzt, proaktiv durch komplexe regulatorische Landschaften zu navigieren. <strong>Durch die Kombination von fortschrittlicher Agentic-KI mit Expertenwissen, <a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a><\/strong> 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><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1262027998 > .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-1058352040\">\n\n\t<div id=\"col-1417471556\" 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-223004465\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-223004465 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW229157140 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW229157140 BCX0\">Was ist eine Erkl\u00e4rung \u00fcber sachkundiges Personal gem\u00e4\u00df der NPRA-Richtlinie?<\/span><\/span><span class=\"EOP SCXW229157140 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-1965129013\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1965129013 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es handelt sich um ein obligatorisches Dokument, das die Einhaltung der GMP-Richtlinien f\u00fcr Pr\u00fcfpr\u00e4parate best\u00e4tigt, die in L\u00e4ndern hergestellt werden, die keine offiziellen GMP-Zertifikate ausstellen.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1417471556 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1487687314\" 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>Welche Anwendungen sind von dieser Anforderung betroffen?<\/h4>\n\t<div id=\"gap-1702185236\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1702185236 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Alles neu <strong>CTIL- und CTX-Anwendungen<\/strong> Dies gilt auch f\u00fcr Pr\u00fcfpr\u00e4parate, die aus betroffenen Regionen stammen.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1487687314 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-127901999\" 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>Auf welche GMP-Standards muss in der Erkl\u00e4rung verwiesen werden?<\/h4>\n\t<div id=\"gap-1386376260\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1386376260 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Die Erkl\u00e4rung muss die GMP-Gleichwertigkeit best\u00e4tigen<strong> ICH- oder PIC\/S-Standards,<\/strong> untermauert durch Pr\u00fcfdetails oder schriftliche Begr\u00fcndung.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-127901999 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1030483236\" 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 Organisationen dabei helfen, diese NPRA-Richtlinie einzuhalten?<\/h4>\n\t<div id=\"gap-1439007233\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1439007233 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong><a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a><\/strong> Unterst\u00fctzt die Teams aus den Bereichen Regulierung und Qualit\u00e4t dabei, Aktualisierungen der NPRA zu verfolgen, die Anwendbarkeit auf laufende klinische Studien zu beurteilen und die Dokumentationsabl\u00e4ufe zu optimieren, die zur Unterst\u00fctzung von GMP-Konformit\u00e4tserkl\u00e4rungen erforderlich sind.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1030483236 > .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 23 February 2026, the National Pharmaceutical Regulatory Agency (NPRA) published a new directive under the Drugs and Cosmetics Control Regulations introducing additional Good Manufacturing Practices (GMP) compliance requirements for investigational medicinal products used in clinical trials in Malaysia. The directive affects manufacturers, importers, and sponsors applying for Clinical Trial Import Licenses (CTIL) or Clinical&#8230;<\/p>","protected":false},"author":41,"featured_media":9584,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,584],"tags":[],"class_list":["post-9582","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-malaysia-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>NPRA Malaysia Mandates Declaration of Competent Personnel<\/title>\n<meta name=\"description\" content=\"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. Learn more now.\" \/>\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-malaysische-npra-schreibt-die-benennung-von-sachkundigem-personal-fur-die-gmp-konformitat-bei-klinischen-prufprodukten-vor\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NPRA Malaysia Mandates Declaration of Competent Personnel for GMP Compliance in Clinical Trial Products\" \/>\n<meta property=\"og:description\" content=\"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. 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