{"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":"lautorite-malaisienne-de-reglementation-des-produits-cliniques-npra-exige-la-declaration-du-personnel-competent-pour-la-conformite-aux-bpf-dans-les-produits-dessais-cliniques","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","title":{"rendered":"L&#039;autorit\u00e9 malaisienne de r\u00e9glementation des r\u00e9glementations nationales (NPRA) exige une d\u00e9claration de personne comp\u00e9tente\u2026"},"content":{"rendered":"<p>Sur <strong>23 f\u00e9vrier 2026,<\/strong> le <strong>Agence nationale de r\u00e9glementation pharmaceutique (NPRA)<\/strong> une nouvelle directive a \u00e9t\u00e9 publi\u00e9e en vertu du R\u00e8glement sur le contr\u00f4le des m\u00e9dicaments et des produits cosm\u00e9tiques, introduisant des mesures suppl\u00e9mentaires. <strong>Bonnes pratiques de fabrication (BPF)<\/strong> exigences de conformit\u00e9 pour <strong>m\u00e9dicaments exp\u00e9rimentaux<\/strong> utilis\u00e9e dans le cadre d&#039;essais cliniques en Malaisie. La directive a une incidence <strong>fabricants, importateurs et sponsors<\/strong> postuler<strong> Licences d&#039;importation d&#039;essais cliniques (CTIL) <\/strong>ou<strong> Exemptions pour essais cliniques (CTX) <\/strong>et est<strong> \u00e0 compter de ce jour. <\/strong><\/p>\n<div class=\"row\"  id=\"row-29884422\">\n\n\t<div id=\"col-1662514106\" 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-671997795\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-671997795 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-2134312439\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2134312439 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>En vertu de la nouvelle directive, les candidats doivent soumettre un <strong>D\u00e9claration du personnel comp\u00e9tent<\/strong> comme preuve formelle de conformit\u00e9 aux BPF lorsque des m\u00e9dicaments exp\u00e9rimentaux sont fabriqu\u00e9s dans des juridictions o\u00f9 les autorit\u00e9s ne d\u00e9livrent pas de certificats officiels de BPF. Cela inclut les produits provenant de <strong>La Chine, les \u00c9tats-Unis, les pays de l&#039;ASEAN et d&#039;autres r\u00e9gions<\/strong> sans cadre de certification BPF.<\/p>\n<p>La d\u00e9claration doit confirmer que les activit\u00e9s de fabrication sont <strong>\u00e9quivalent aux normes ICH ou PIC\/S GMP.<\/strong> Il doit \u00e9galement inclure <strong>d\u00e9tails de l&#039;audit<\/strong> men\u00e9s par du personnel qualifi\u00e9 ou, lorsque des audits ne sont pas effectu\u00e9s, par un <strong>justification \u00e9crite<\/strong> explication de la justification. Sur la base des d\u00e9clarations soumises, <strong>Les sites de fabrication peuvent faire l&#039;objet d&#039;une inspection de la NPRA.<\/strong> dans le cadre du processus d&#039;examen.<\/p>\n<p>Tous <strong>nouvelles applications CTIL et CTX<\/strong> Les entreprises commercialisant des m\u00e9dicaments exp\u00e9rimentaux provenant de r\u00e9gions touch\u00e9es sont tenues de se conformer \u00e0 ces dispositions.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1662514106 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1294456412\" 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>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-268481800\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-268481800 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette directive fournit <strong>clart\u00e9 r\u00e9glementaire<\/strong> Pour les promoteurs d&#039;essais cliniques qui s&#039;approvisionnent en m\u00e9dicaments exp\u00e9rimentaux aupr\u00e8s de pays ne d\u00e9livrant pas de certification BPF. En formalisant les preuves alternatives de conformit\u00e9 aux BPF par le biais d&#039;une d\u00e9claration de personnel comp\u00e9tent, la NPRA apporte son soutien. <strong>alignement r\u00e9glementaire sur les normes internationales,<\/strong> am\u00e9liore <strong>efficacit\u00e9 de la surveillance,<\/strong> et garantit la conformit\u00e9 tout en minimisant les obstacles proc\u00e9duraux \u00e0 l&#039;approbation des essais cliniques.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1294456412 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1920373643\" 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>\u00c0 qui cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-1296934188\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1296934188 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour concerne <strong>\u00c9quipes des affaires r\u00e9glementaires, de l&#039;assurance qualit\u00e9, des op\u00e9rations cliniques et de la conformit\u00e9,<\/strong> ainsi que <strong>fabricants, importateurs et sponsors<\/strong> impliqu\u00e9s dans l&#039;importation ou la fabrication de m\u00e9dicaments exp\u00e9rimentaux destin\u00e9s \u00e0 des essais cliniques en Malaisie.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1920373643 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-79864471\" 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>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-815360897\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-815360897 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les parties prenantes devraient examiner les mesures actuelles et \u00e0 venir <strong>CTIL et CTX<\/strong> <strong>applications<\/strong> afin d\u2019identifier les m\u00e9dicaments exp\u00e9rimentaux provenant des juridictions concern\u00e9es. Les \u00e9quipes des affaires r\u00e9glementaires doivent se coordonner avec <strong>Assurance qualit\u00e9<\/strong> pr\u00e9parer les \u00e9l\u00e9ments requis <strong>D\u00e9claration du personnel comp\u00e9tent,<\/strong> Il convient de s&#039;assurer que les d\u00e9clarations d&#039;\u00e9quivalence aux BPF, la documentation d&#039;audit et les justifications \u00e9crites sont compl\u00e8tes et conformes aux exigences de la NPRA. Les processus internes de qualification et de documentation des fournisseurs doivent \u00e9galement \u00eatre revus et mis \u00e0 jour afin de garantir une conformit\u00e9 continue.<\/p>\n<p>Alors que les exigences r\u00e9glementaires relatives aux produits des essais cliniques continuent d&#039;\u00e9voluer dans diff\u00e9rentes juridictions, <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> aide les \u00e9quipes \u00e0 rester conformes aux exigences locales en mati\u00e8re de bonnes pratiques de fabrication (BPF) et de soumission. <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentielle, qui permet aux organisations mondiales des secteurs hautement r\u00e9glement\u00e9s, notamment les produits de consommation et les sciences de la vie, de naviguer de mani\u00e8re proactive dans des environnements r\u00e9glementaires complexes. <strong>En combinant une IA agentique avanc\u00e9e avec des experts impliqu\u00e9s, <a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a><\/strong> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <a href=\"http:\/\/regask.com\/fr\/\"><strong>En savoir plus <\/strong><\/a>ou<a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"><strong> r\u00e9servez une d\u00e9mo maintenant.<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-79864471 > .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-849325825\">\n\n\t<div id=\"col-1820244832\" 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>FAQ<\/h3>\n\t<div id=\"gap-1627144348\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1627144348 {\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\">Qu\u2019est-ce qu\u2019une d\u00e9claration de personnel comp\u00e9tent au sens de la directive NPRA\u00a0?<\/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-107623603\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-107623603 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Il s&#039;agit d&#039;un document obligatoire confirmant la conformit\u00e9 aux BPF pour les m\u00e9dicaments exp\u00e9rimentaux fabriqu\u00e9s dans des juridictions qui ne d\u00e9livrent pas de certificats officiels de BPF.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1820244832 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-607331376\" 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>Quelles applications sont concern\u00e9es par cette exigence\u00a0?<\/h4>\n\t<div id=\"gap-1963046703\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1963046703 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Tout nouveau <strong>Applications CTIL et CTX<\/strong> Les produits m\u00e9dicinaux exp\u00e9rimentaux provenant de r\u00e9gions touch\u00e9es doivent se conformer aux r\u00e9glementations.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-607331376 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-304723657\" 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>Quelles normes BPF doivent \u00eatre mentionn\u00e9es dans la d\u00e9claration\u00a0?<\/h4>\n\t<div id=\"gap-714183828\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-714183828 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La d\u00e9claration doit confirmer l&#039;\u00e9quivalence des BPF \u00e0<strong> normes ICH ou PIC\/S,<\/strong> appuy\u00e9 par des d\u00e9tails d&#039;audit ou une justification \u00e9crite.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-304723657 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1515890423\" 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>Comment la norme RegASK peut-elle aider les organisations \u00e0 se conformer \u00e0 cette directive de la NPRA\u00a0?<\/h4>\n\t<div id=\"gap-388311844\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-388311844 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong><a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a><\/strong> aide les \u00e9quipes r\u00e9glementaires et qualit\u00e9 \u00e0 suivre les mises \u00e0 jour de la NPRA, \u00e0 \u00e9valuer leur applicabilit\u00e9 aux essais cliniques en cours et \u00e0 rationaliser les flux de travail documentaires n\u00e9cessaires pour \u00e9tayer les d\u00e9clarations de conformit\u00e9 aux BPF.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1515890423 > .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\/fr\/lautorite-malaisienne-de-reglementation-des-produits-cliniques-npra-exige-la-declaration-du-personnel-competent-pour-la-conformite-aux-bpf-dans-les-produits-dessais-cliniques\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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. Learn more now.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/lautorite-malaisienne-de-reglementation-des-produits-cliniques-npra-exige-la-declaration-du-personnel-competent-pour-la-conformite-aux-bpf-dans-les-produits-dessais-cliniques\/\" \/>\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=\"2026-03-03T13:42:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-03T13:43:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.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=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\"},\"author\":{\"name\":\"Shaffa Renaningtyas\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\"},\"headline\":\"NPRA Malaysia Mandates Declaration of Competent Personn&hellip;\",\"datePublished\":\"2026-03-03T13:42:52+00:00\",\"dateModified\":\"2026-03-03T13:43:42+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\"},\"wordCount\":737,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\",\"articleSection\":[\"Regulatory News\",\"Medical Devices\",\"Malaysia\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\",\"name\":\"NPRA Malaysia Mandates Declaration of Competent Personnel\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\",\"datePublished\":\"2026-03-03T13:42:52+00:00\",\"dateModified\":\"2026-03-03T13:43:42+00:00\",\"description\":\"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. Learn more now.\",\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\",\"width\":800,\"height\":600,\"caption\":\"Npra Malaysia Mandates Declaration Competent Personnel Gmp Compliance Clinical Trial Products\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/@RegASK\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\",\"name\":\"Shaffa Renaningtyas\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"L&#039;Autorit\u00e9 nationale de r\u00e9glementation des agences de r\u00e9glementation (NPRA) de Malaisie exige une d\u00e9claration du personnel comp\u00e9tent","description":"L\u2019autorit\u00e9 malaisienne de r\u00e9glementation des produits pharmaceutiques (NPRA) exige une d\u00e9claration du personnel comp\u00e9tent pour la conformit\u00e9 aux BPF des produits destin\u00e9s aux essais cliniques. Apprenez-en davantage d\u00e8s maintenant.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/fr\/lautorite-malaisienne-de-reglementation-des-produits-cliniques-npra-exige-la-declaration-du-personnel-competent-pour-la-conformite-aux-bpf-dans-les-produits-dessais-cliniques\/","og_locale":"fr_FR","og_type":"article","og_title":"NPRA Malaysia Mandates Declaration of Competent Personnel for GMP Compliance in Clinical Trial Products","og_description":"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. Learn more now.","og_url":"https:\/\/regask.com\/fr\/lautorite-malaisienne-de-reglementation-des-produits-cliniques-npra-exige-la-declaration-du-personnel-competent-pour-la-conformite-aux-bpf-dans-les-produits-dessais-cliniques\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-03-03T13:42:52+00:00","article_modified_time":"2026-03-03T13:43:42+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","type":"image\/png"}],"author":"Shaffa Renaningtyas","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Shaffa Renaningtyas","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#article","isPartOf":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/"},"author":{"name":"Shaffa Renaningtyas","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6"},"headline":"NPRA Malaysia Mandates Declaration of Competent Personn&hellip;","datePublished":"2026-03-03T13:42:52+00:00","dateModified":"2026-03-03T13:43:42+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/"},"wordCount":737,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","articleSection":["Regulatory News","Medical Devices","Malaysia"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","url":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","name":"L&#039;Autorit\u00e9 nationale de r\u00e9glementation des agences de r\u00e9glementation (NPRA) de Malaisie exige une d\u00e9claration du personnel comp\u00e9tent","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","datePublished":"2026-03-03T13:42:52+00:00","dateModified":"2026-03-03T13:43:42+00:00","description":"L\u2019autorit\u00e9 malaisienne de r\u00e9glementation des produits pharmaceutiques (NPRA) exige une d\u00e9claration du personnel comp\u00e9tent pour la conformit\u00e9 aux BPF des produits destin\u00e9s aux essais cliniques. Apprenez-en davantage d\u00e8s maintenant.","inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","width":800,"height":600,"caption":"Npra Malaysia Mandates Declaration Competent Personnel Gmp Compliance Clinical Trial Products"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Favoriser des d\u00e9cisions r\u00e9glementaires plus intelligentes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/@RegASK"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6","name":"Shaffa Renaningtyas"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/9582","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/users\/41"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/comments?post=9582"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/9582\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media\/9584"}],"wp:attachment":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media?parent=9582"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/categories?post=9582"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/tags?post=9582"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}