{"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":"la-npra-de-malasia-exige-la-declaracion-de-personal-competente-para-el-cumplimiento-de-las-bpm-en-productos-de-ensayos-clinicos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","title":{"rendered":"La NPRA de Malasia exige la declaraci\u00f3n de personal competente\u2026"},"content":{"rendered":"<p>En <strong>23 de febrero de 2026,<\/strong> el <strong>Agencia Nacional de Regulaci\u00f3n Farmac\u00e9utica (NPRA)<\/strong> public\u00f3 una nueva directiva bajo el Reglamento de Control de Medicamentos y Cosm\u00e9ticos que introduce <strong>Buenas pr\u00e1cticas de fabricaci\u00f3n (BPF)<\/strong> requisitos de cumplimiento para <strong>productos medicinales en investigaci\u00f3n<\/strong> utilizado en ensayos cl\u00ednicos en Malasia. La directiva afecta <strong>fabricantes, importadores y patrocinadores<\/strong> solicitando<strong> Licencias de importaci\u00f3n para ensayos cl\u00ednicos (CTIL) <\/strong>o<strong> Exenciones de ensayos cl\u00ednicos (CTX) <\/strong>y es<strong> efectivo inmediatamente. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1459330250\">\n\n\t<div id=\"col-1175964421\" 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-2010084106\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2010084106 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-1351335778\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1351335778 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Seg\u00fan la nueva directiva, los solicitantes deben presentar una <strong>Declaraci\u00f3n de Personal Competente<\/strong> como prueba formal del cumplimiento de las BPM cuando los medicamentos en investigaci\u00f3n se fabrican en jurisdicciones donde las autoridades no emiten certificados oficiales de BPM. Esto incluye productos procedentes de <strong>China, Estados Unidos, pa\u00edses de la ASEAN y otras regiones<\/strong> sin marcos de certificaci\u00f3n GMP.<\/p>\n<p>La declaraci\u00f3n debe confirmar que las actividades de fabricaci\u00f3n son <strong>equivalente a los est\u00e1ndares GMP ICH o PIC\/S.<\/strong> Tambi\u00e9n debe incluir <strong>detalles de la auditor\u00eda<\/strong> realizadas por personal calificado o, cuando no se realicen auditor\u00edas, por un <strong>justificaci\u00f3n escrita<\/strong> Explicando la justificaci\u00f3n. Con base en las declaraciones presentadas, <strong>Los sitios de fabricaci\u00f3n pueden estar sujetos a la inspecci\u00f3n de la NPRA<\/strong> como parte del proceso de revisi\u00f3n.<\/p>\n<p>Todo <strong>Nuevas aplicaciones CTIL y CTX<\/strong> Los medicamentos en investigaci\u00f3n procedentes de regiones afectadas deben cumplir estas disposiciones.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1175964421 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-147794624\" 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>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-1092119230\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1092119230 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta directiva establece: <strong>claridad regulatoria<\/strong> Para los patrocinadores de ensayos cl\u00ednicos que obtienen medicamentos en investigaci\u00f3n de pa\u00edses sin certificaci\u00f3n de BPM. Al formalizar la evidencia alternativa de BPM mediante una Declaraci\u00f3n de Personal Competente, la NPRA apoya <strong>alineaci\u00f3n regulatoria con los est\u00e1ndares internacionales,<\/strong> mejora <strong>eficiencia de la supervisi\u00f3n,<\/strong> y mantiene la garant\u00eda de cumplimiento al tiempo que minimiza las barreras procesales para las aprobaciones de ensayos cl\u00ednicos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-147794624 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1539385344\" 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>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-1041000549\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1041000549 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La actualizaci\u00f3n es relevante para <strong>Equipos de Asuntos Regulatorios, Garant\u00eda de Calidad, Operaciones Cl\u00ednicas y Cumplimiento,<\/strong> as\u00ed como <strong>fabricantes, importadores y patrocinadores<\/strong> involucrada en la importaci\u00f3n o fabricaci\u00f3n de productos medicinales en investigaci\u00f3n para ensayos cl\u00ednicos en Malasia.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1539385344 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-991604404\" 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>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-1777228264\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1777228264 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las partes interesadas deben revisar las actividades actuales y futuras. <strong>CTIL y CTX<\/strong> <strong>aplicaciones<\/strong> para identificar medicamentos en investigaci\u00f3n provenientes de las jurisdicciones afectadas. Los equipos de Asuntos Regulatorios deben coordinarse con <strong>Seguro de calidad<\/strong> para preparar lo requerido <strong>Declaraci\u00f3n de Personal Competente,<\/strong> Garantizar que las declaraciones de equivalencia de BPM, la documentaci\u00f3n de auditor\u00eda o las justificaciones escritas est\u00e9n completas y se ajusten a las expectativas de la NPRA. Los procesos internos de calificaci\u00f3n y documentaci\u00f3n de proveedores tambi\u00e9n deben revisarse y actualizarse para garantizar el cumplimiento continuo.<\/p>\n<p>A medida que los requisitos reglamentarios para los productos de ensayos cl\u00ednicos contin\u00faan evolucionando en las distintas jurisdicciones, <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Ayuda a los equipos a mantenerse alineados con las expectativas de GMP locales y los requisitos de presentaci\u00f3n. <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujo de trabajo con inteligencia artificial (IA) que permite a las organizaciones globales en sectores altamente regulados, incluidos productos de consumo y ciencias biol\u00f3gicas, navegar de manera proactiva en panoramas regulatorios complejos. <strong>Al combinar la IA avanzada de Agentic con expertos en el sector, <a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, agilizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses. <a href=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>o<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong> Reserve una demostraci\u00f3n ahora.<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-991604404 > .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-407042103\">\n\n\t<div id=\"col-882435429\" 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>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-862659580\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-862659580 {\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\">\u00bfQu\u00e9 es una Declaraci\u00f3n de Personal Competente seg\u00fan la directiva NPRA?<\/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-983514121\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-983514121 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es un documento obligatorio que confirma el cumplimiento de las BPM para los productos medicinales en investigaci\u00f3n fabricados en jurisdicciones que no emiten certificados BPM oficiales.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-882435429 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1587357252\" 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>\u00bfQu\u00e9 aplicaciones se ven afectadas por este requisito?<\/h4>\n\t<div id=\"gap-514866522\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-514866522 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Todo nuevo <strong>Aplicaciones CTIL y CTX<\/strong> Los medicamentos en investigaci\u00f3n procedentes de regiones afectadas deben cumplir.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1587357252 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1226684851\" 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>\u00bfQu\u00e9 normas GMP deben referenciarse en la declaraci\u00f3n?<\/h4>\n\t<div id=\"gap-40853968\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-40853968 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La declaraci\u00f3n debe confirmar la equivalencia de las BPM con<strong> Normas ICH o PIC\/S,<\/strong> respaldado por detalles de auditor\u00eda o justificaci\u00f3n escrita.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1226684851 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1210083942\" 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>\u00bfC\u00f3mo puede RegASK ayudar a las organizaciones a cumplir con esta directiva NPRA?<\/h4>\n\t<div id=\"gap-1479897906\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1479897906 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong><a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> Ayuda a los equipos regulatorios y de calidad a rastrear las actualizaciones de NPRA, evaluar la aplicabilidad a los ensayos cl\u00ednicos en curso y agilizar los flujos de trabajo de documentaci\u00f3n necesarios para respaldar las declaraciones de cumplimiento de GMP.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1210083942 > .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 v27.4) - 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. 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