{"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-1572610903\">\n\n\t<div id=\"col-1711599587\" 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-1687113812\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1687113812 {\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-1722379465\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1722379465 {\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-1711599587 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1482900209\" 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-1536781363\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1536781363 {\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-1482900209 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-171524265\" 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-895733382\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-895733382 {\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-171524265 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1599557745\" 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-473881283\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-473881283 {\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-1599557745 > .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-1981847245\">\n\n\t<div id=\"col-2137355705\" 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-1434405570\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1434405570 {\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-1782152794\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1782152794 {\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-2137355705 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-40574072\" 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-1847315483\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1847315483 {\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-40574072 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-169528352\" 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-423070906\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-423070906 {\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-169528352 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2115146966\" 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-893737899\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-893737899 {\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-2115146966 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 26 de marzo de 2026, la Asociaci\u00f3n Japonesa de Fabricantes Farmac\u00e9uticos (JPMA) public\u00f3 una lista de verificaci\u00f3n de autoinspecci\u00f3n revisada para las pruebas de calidad, introduciendo un marco actualizado para respaldar la fiabilidad y la validez cient\u00edfica de los datos de calidad farmac\u00e9utica presentados en las solicitudes de nuevos medicamentos en Jap\u00f3n.\u00a0<\/p>","protected":false},"author":43,"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 v27.6 (Yoast SEO v27.7) - 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 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