{"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":"japon-actualiza-la-lista-de-verificacion-de-autoinspeccion-de-la-jpma-para-las-pruebas-de-calidad-en-las-solicitudes-de-nuevos-medicamentos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications\/","title":{"rendered":"Jap\u00f3n actualiza la lista de verificaci\u00f3n de autoinspecci\u00f3n de la JPMA para la calidad\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">En\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 de marzo de 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> el<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\">Asociaci\u00f3n Japonesa de Fabricantes Farmac\u00e9uticos (JPMA) <\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">public\u00f3 una <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">Lista de verificaci\u00f3n de autoinspecci\u00f3n revisada para pruebas de calidad<\/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> introducir un marco actualizado para apoyar la\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\">fiabilidad y validez cient\u00edfica de los datos de calidad farmac\u00e9utica<\/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\">enviado<\/span><span class=\"NormalTextRun SCXW31536731 BCX0\">\u00a0en solicitudes de nuevos f\u00e1rmacos en Jap\u00f3n.<\/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-1260747379\">\n\n\t<div id=\"col-704228024\" 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-2010004096\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2010004096 {\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-877007038\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-877007038 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La lista de verificaci\u00f3n actualizada reemplaza a la anterior.\u00a0<\/span><b><span data-contrast=\"auto\">lista de verificaci\u00f3n de inspecci\u00f3n de conformidad basada en documentos<\/span><\/b><span data-contrast=\"auto\">\u00a0y consolida\u00a0<\/span><b><span data-contrast=\"auto\">Pruebas anal\u00edticas y pruebas de estabilidad en un \u00fanico marco unificado<\/span><\/b><span data-contrast=\"auto\">. Esta integraci\u00f3n tiene como objetivo simplificar la forma en que los solicitantes eval\u00faan y demuestran la fiabilidad de los datos de calidad en las presentaciones regulatorias.<\/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\">La revisi\u00f3n elimina expl\u00edcitamente\u00a0<\/span><b><span data-contrast=\"auto\">elementos de estudios no cl\u00ednicos<\/span><\/b><span data-contrast=\"auto\">, reduciendo el alcance de la lista de verificaci\u00f3n para centrarse en las pruebas de calidad relevantes para la aprobaci\u00f3n del producto. Tambi\u00e9n aclara que la lista de verificaci\u00f3n es\u00a0<\/span><b><span data-contrast=\"auto\">No se trata de una lista prescriptiva de documentos requeridos.<\/span><\/b><span data-contrast=\"auto\">, sino m\u00e1s bien una herramienta dise\u00f1ada para brindar soporte.\u00a0<\/span><b><span data-contrast=\"auto\">evaluaci\u00f3n de la fiabilidad general<\/span><\/b><span data-contrast=\"auto\">\u00a0de los datos enviados.<\/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\">Adem\u00e1s, la lista de verificaci\u00f3n enfatiza que los solicitantes deben asegurarse de que\u00a0<\/span><b><span data-contrast=\"auto\">preparaci\u00f3n, realizaci\u00f3n y documentaci\u00f3n de las pruebas<\/span><\/b><span data-contrast=\"auto\">\u00a0cumplir con los est\u00e1ndares de confiabilidad establecidos. Para\u00a0<\/span><b><span data-contrast=\"auto\">pruebas contratadas<\/span><\/b><span data-contrast=\"auto\">, Los solicitantes deben mantener\u00a0<\/span><b><span data-contrast=\"auto\">m\u00e9todos documentados para confirmar la fiabilidad de las pruebas<\/span><\/b><span data-contrast=\"auto\">, reforzando la rendici\u00f3n de cuentas incluso en la subcontrataci\u00f3n.<\/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\">La actualizaci\u00f3n subraya a\u00fan m\u00e1s la importancia de\u00a0<\/span><b><span data-contrast=\"auto\">cumplimiento de los registros electr\u00f3nicos<\/span><\/b><span data-contrast=\"auto\">, que requiere el cumplimiento de los procedimientos establecidos, incluidos aquellos alineados con\u00a0<\/span><b><span data-contrast=\"auto\">Directrices sobre registros electr\u00f3nicos y firmas electr\u00f3nicas<\/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\">El\u00a0<\/span><b><span data-contrast=\"auto\">JPMA<\/span><\/b><span data-contrast=\"auto\">\u00a0se\u00f1ala que\u00a0<\/span><b><span data-contrast=\"auto\">Se esperan revisiones continuas.<\/span><\/b><span data-contrast=\"auto\">\u00a0a medida que las pr\u00e1cticas de la industria contin\u00faan evolucionando.<\/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-704228024 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-543798764\" 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-1292629709\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1292629709 {\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\">Esta actualizaci\u00f3n mejora<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\">claridad regulatoria<\/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>por\u00a0<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">consolidando<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0Las expectativas de las pruebas de calidad se integran en un \u00fanico marco y se eliminan los elementos irrelevantes. Esto permite...\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\">alineaci\u00f3n digital<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0a trav\u00e9s de expectativas m\u00e1s claras para los registros electr\u00f3nicos y mejora\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\">eficiencia operativa<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0simplificando los procesos de autoinspecci\u00f3n. Al mismo tiempo,\u00a0<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">mantiene<\/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\">enfoque no prescriptivo<\/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> Minimizar la carga innecesaria de cumplimiento normativo al tiempo que se garantiza la fiabilidad de los datos.<\/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-543798764 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-244567957\" 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>A qui\u00e9n afecta esto<\/h2>\n\t<div id=\"gap-361311468\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-361311468 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para<strong> equipos de garant\u00eda de calidad (QA), asuntos regulatorios (RA) e I+D<\/strong> dentro de las compa\u00f1\u00edas farmac\u00e9uticas que se preparan<strong> solicitudes de nuevos medicamentos en Jap\u00f3n,<\/strong> particularmente aquellos involucrados en <strong>Pruebas de calidad, integridad de los datos y preparaci\u00f3n para la presentaci\u00f3n. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-244567957 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-178577389\" 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-1491225467\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1491225467 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las organizaciones deber\u00edan\u00a0<\/span><b><span data-contrast=\"auto\">revisar y actualizar los procedimientos internos de pruebas de calidad y las pr\u00e1cticas de autoinspecci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0para alinearse con la lista de verificaci\u00f3n revisada. Los equipos tambi\u00e9n deber\u00edan\u00a0<\/span><b><span data-contrast=\"auto\">evaluar los flujos de trabajo de documentaci\u00f3n actuales<\/span><\/b><span data-contrast=\"auto\">\u00a0para asegurar que\u00a0<\/span><b><span data-contrast=\"auto\">est\u00e1ndares de validez cient\u00edfica, integridad de los datos y fiabilidad<\/span><\/b><span data-contrast=\"auto\">\u00a0Se cumplen sistem\u00e1ticamente. La coordinaci\u00f3n interfuncional entre control de calidad, asuntos regulatorios e I+D ser\u00e1 esencial para garantizar la plena alineaci\u00f3n con el marco actualizado.<\/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 medida que las expectativas regulatorias en torno a la confiabilidad de los datos y el cumplimiento digital contin\u00faan evolucionando, las soluciones como\u00a0<\/span><b><span data-contrast=\"auto\">RegASK<\/span><\/b><span data-contrast=\"auto\">\u00a0puede ayudar a las organizaciones a mantenerse a la vanguardia.\u00a0<a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a>\u00a0Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA agentic que permite a organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar IA agentic avanzada con expertos en el sector,\u00a0<a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a>\u00a0Ofrece informaci\u00f3n predictiva y pr\u00e1ctica en tiempo real, as\u00ed como automatizaci\u00f3n integral, lo que agiliza los procesos de cumplimiento, mitiga los riesgos y acelera el acceso al mercado en m\u00e1s de 160 pa\u00edses. <strong><a href=\"http:\/\/regask.com\/es\/\">M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reserve una demostraci\u00f3n ahora.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-178577389 > .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-1726551084\">\n\n\t<div id=\"col-229832853\" 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-391133353\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-391133353 {\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\">\u00bfCu\u00e1l es la lista de verificaci\u00f3n de autoinspecci\u00f3n de la JPMA para las pruebas de calidad?<\/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-1421274426\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1421274426 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es una herramienta publicada por el <strong>Asociaci\u00f3n Japonesa de Fabricantes Farmac\u00e9uticos (JPMA)<\/strong> para ayudar a los solicitantes a evaluar la <strong>fiabilidad y validez cient\u00edfica de los datos de las pruebas de calidad<\/strong> presentado en solicitudes de nuevos medicamentos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-229832853 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-941524079\" 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\">\u00bfCu\u00e1les son las principales novedades de la lista de verificaci\u00f3n revisada?<\/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-369963917\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-369963917 {\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\">La lista de verificaci\u00f3n ahora\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\">integra an\u00e1lisis y pruebas de estabilidad<\/span><\/span><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">, elimina\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">elementos de estudios no cl\u00ednicos<\/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> y enfatiza\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\">fiabilidad de los datos, est\u00e1ndares de documentaci\u00f3n y cumplimiento de los registros electr\u00f3nicos<\/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-941524079 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-660904127\" 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\">\u00bfLa lista de verificaci\u00f3n especifica los documentos que se deben presentar?<\/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-206928873\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-206928873 {\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\">No. La lista de verificaci\u00f3n es\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\">no prescriptivo<\/span><\/span><\/strong><span class=\"TextRun SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">\u00a0y no define una lista fija de documentos requeridos. Su prop\u00f3sito es brindar soporte.\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\">evaluaci\u00f3n de la fiabilidad general<\/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-660904127 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1500108991\" 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\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW241486931 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW241486931 BCX0\">\u00a0\u00bfNecesita ayuda para cumplir con esta actualizaci\u00f3n?<\/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-2038856504\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2038856504 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a>\u00a0ayuda a las organizaciones a monitorear las expectativas regulatorias en constante evoluci\u00f3n,\u00a0<\/span><b><span data-contrast=\"auto\">Alinear los procesos internos con los marcos de trabajo actualizados.<\/span><\/b><span data-contrast=\"auto\">, y garantizar\u00a0<\/span><b><span data-contrast=\"auto\">Integridad de los datos y preparaci\u00f3n para su env\u00edo<\/span><\/b><span data-contrast=\"auto\">\u00a0mediante inteligencia regulatoria impulsada por IA y automatizaci\u00f3n de flujos de trabajo.<\/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-1500108991 > .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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