{"id":8712,"date":"2025-09-23T17:28:11","date_gmt":"2025-09-23T09:28:11","guid":{"rendered":"https:\/\/regask.com\/?p=8712"},"modified":"2025-09-23T17:28:11","modified_gmt":"2025-09-23T09:28:11","slug":"indonesia-bpom-revisa-las-normas-de-registro-de-medicamentos-para-agilizar-los-plazos-y-el-etiquetado","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\/","title":{"rendered":"Indonesia BPOM revisa las reglas de registro de medicamentos para transmitir..."},"content":{"rendered":"<p><span class=\"TextRun MacChromeBold SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW6263149 BCX0\">Publicado el 19 de agosto de 2025 por el\u00a0<\/span><\/span><a class=\"Hyperlink SCXW6263149 BCX0\" href=\"https:\/\/www.pom.go.id\/#:~:text=Beranda,Badan%20Pengawas%20Obat%20dan%20Makanan\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined MacChromeBold SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW6263149 BCX0\" data-ccp-charstyle=\"Hyperlink\">Agencia Nacional de Control de Medicamentos y Alimentos de Indonesia (BPOM)<\/span><\/span><\/a><span class=\"TextRun MacChromeBold SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW6263149 BCX0\">, El Reglamento No. 23 de 2025 introduce modificaciones importantes en los criterios y procedimientos de registro de medicamentos.<\/span><\/span><span class=\"TextRun SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW6263149 BCX0\">\u00a0El reglamento actualiza los plazos de evaluaci\u00f3n, aclara las clasificaciones de productos biol\u00f3gicos y ajusta los requisitos de etiquetado para alinearlos con los est\u00e1ndares internacionales.<\/span><\/span><span class=\"EOP SCXW6263149 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-796303836\">\n\n\t<div id=\"col-81440236\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW242349405 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW242349405 BCX0\" data-ccp-parastyle=\"heading 2\">Resumen de la actualizaci\u00f3n<\/span><\/span><span class=\"EOP SCXW242349405 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-807882644\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-807882644 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Reglamento BPOM No. 23 de 2025, firmado el 1 de agosto y vigente a partir de\u00a0<\/span><b><span data-contrast=\"auto\">12 de agosto de 2025<\/span><\/b><span data-contrast=\"auto\">, revisa el Reglamento n.\u00ba 24 de 2017. La actualizaci\u00f3n se centra en tres \u00e1reas cr\u00edticas:\u00a0<\/span><b><span data-contrast=\"auto\">plazos de evaluaci\u00f3n de medicamentos<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">definiciones de productos biol\u00f3gicos<\/span><\/b><span data-contrast=\"auto\">, y\u00a0<\/span><b><span data-contrast=\"auto\">requisitos de etiquetado de medicamentos<\/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 reglamento establece plazos de evaluaci\u00f3n diferenciados seg\u00fan el tipo de producto y la urgencia. Por ejemplo,\u00a0<\/span><b><span data-contrast=\"auto\">autorizaci\u00f3n de uso de emergencia para medicamentos gen\u00e9ricos<\/span><\/b><span data-contrast=\"auto\">\u00a0ahora s\u00f3lo requiere cinco d\u00edas de revisi\u00f3n, mientras que\u00a0<\/span><b><span data-contrast=\"auto\">nuevos medicamentos que abordan enfermedades potencialmente mortales o enfermedades raras\u00a0<\/span><\/b><a href=\"https:\/\/www.fda.gov\/industry\/medical-products-rare-diseases-and-conditions\/designating-orphan-product-drugs-and-biological-products\"><b><span data-contrast=\"none\">(Medicamentos hu\u00e9rfanos)<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0Se evaluar\u00e1 dentro de 100 d\u00edas.<\/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\">Definiciones de\u00a0<\/span><b><span data-contrast=\"auto\">productos biol\u00f3gicos<\/span><\/b><span data-contrast=\"auto\">\u00a0Se han ampliado para incluir enzimas, anticuerpos monoclonales, hormonas, vacunas, derivados del plasma, productos de ADN recombinante y terapias avanzadas como\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/what-gene-therapy#:~:text=Gene%20therapy%20products%20are%20being,therapeutic%20genes%20into%20human%20cells.\"><b><span data-contrast=\"none\">terapia g\u00e9nica<\/span><\/b><\/a><b><span data-contrast=\"auto\">\u00a0drogas<\/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><b><span data-contrast=\"auto\">Normas de etiquetado<\/span><\/b><span data-contrast=\"auto\">\u00a0Se han actualizado para requerir informaci\u00f3n m\u00e1s detallada, incluidas las fechas de vencimiento despu\u00e9s de la apertura o reconstituci\u00f3n para formas de dosificaci\u00f3n espec\u00edficas, como gotas para los ojos y polvos liofilizados.<\/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 class=\"TextRun SCXW114287126 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114287126 BCX0\">El reglamento tambi\u00e9n afina\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW114287126 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114287126 BCX0\">v\u00edas de registro<\/span><\/span><span class=\"TextRun SCXW114287126 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114287126 BCX0\">\u00a0para variaciones administrativas, nuevas indicaciones o cambios de posolog\u00eda y la transici\u00f3n de la autorizaci\u00f3n de uso de emergencia a la aprobaci\u00f3n total de comercializaci\u00f3n.<\/span><\/span><span class=\"EOP SCXW114287126 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-81440236 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2076838699\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW244547784 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW244547784 BCX0\" data-ccp-parastyle=\"heading 2\">Fecha l\u00edmite para comentarios<\/span><\/span><span class=\"EOP SCXW244547784 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-632255613\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-632255613 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW158491260 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW158491260 BCX0\">Todas las etiquetas de medicamentos existentes deben actualizarse\u00a0<\/span><span class=\"NormalTextRun SCXW158491260 BCX0\">Cumplir con<\/span><span class=\"NormalTextRun SCXW158491260 BCX0\">\u00a0los requisitos revisados por\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW158491260 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW158491260 BCX0\">12 de agosto de 2027<\/span><\/span><\/strong><span class=\"TextRun SCXW158491260 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW158491260 BCX0\">. Se aplican excepciones al etiquetado de certificaci\u00f3n halal, que se gestiona mediante reglamentos separados.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2076838699 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1705823654\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW213342177 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW213342177 BCX0\" data-ccp-parastyle=\"heading 2\">Por qu\u00e9 es importante<\/span><\/span><\/h3>\n\t<div id=\"gap-1670730918\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1670730918 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW88136145 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88136145 BCX0\">Estas enmiendas tienen por objeto:\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW88136145 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88136145 BCX0\">Acelerar el acceso de los pacientes a terapias esenciales<\/span><\/span><span class=\"TextRun SCXW88136145 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88136145 BCX0\">, especialmente en contextos de emergencia o enfermedades raras, a la vez que se alinea el marco regulatorio de Indonesia con los sistemas reconocidos internacionalmente. Al redefinir las categor\u00edas de productos y perfeccionar los requisitos de etiquetado, BPOM mejora la claridad regulatoria y minimiza la carga administrativa para la industria.<\/span><\/span><span class=\"EOP SCXW88136145 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-1705823654 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1835151375\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW203674993 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW203674993 BCX0\" data-ccp-parastyle=\"heading 2\">\u00bfQui\u00e9n deber\u00eda tomar nota?<\/span><\/span><\/h3>\n\t<div id=\"gap-673087792\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-673087792 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW72162094 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72162094 BCX0\">Esta actualizaci\u00f3n es especialmente relevante para\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW72162094 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72162094 BCX0\">equipos de asuntos regulatorios, funciones de garant\u00eda de calidad, equipos de desarrollo de productos y profesionales de acceso al mercado<\/span><\/span><span class=\"TextRun SCXW72162094 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72162094 BCX0\">\u00a0Gesti\u00f3n de registros de medicamentos en Indonesia. Las empresas que trabajan con productos biol\u00f3gicos y con aprobaciones urgentes ser\u00e1n las m\u00e1s afectadas.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1835151375 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1100861737\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW133163949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW133163949 BCX0\" data-ccp-parastyle=\"heading 2\">Pr\u00f3ximos pasos<\/span><\/span><\/h3>\n\t<div id=\"gap-1407032044\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1407032044 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las partes interesadas deben:<\/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<ul>\n<li><span data-contrast=\"auto\">Revise las clasificaciones de productos existentes frente a las definiciones ampliadas.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Audite las etiquetas actuales para planificar actualizaciones antes de la fecha l\u00edmite de cumplimiento.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Alinear las estrategias regulatorias con oportunidades de revisi\u00f3n acelerada en pa\u00edses de referencia, incluidos EE. UU., la UE, Jap\u00f3n, Canad\u00e1, Australia, Suiza y el Reino Unido.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Para mantenerse a la vanguardia de los requisitos cambiantes, las empresas deben adoptar sistemas que respalden el monitoreo regulatorio global oportuno, la documentaci\u00f3n y la gesti\u00f3n de presentaciones.\u00a0<\/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><a href=\"https:\/\/regask.com\/es\/\"><b><span data-contrast=\"none\">RegASK<\/span><\/b><\/a><b><span data-contrast=\"none\">\u00a0es una soluci\u00f3n impulsada por IA para la inteligencia regulatoria y la orquestaci\u00f3n del flujo de trabajo\u00a0<\/span><\/b><span data-contrast=\"none\">Ayudamos a las empresas de ciencias biol\u00f3gicas y bienes de consumo envasados a mantenerse a la vanguardia de las cambiantes regulaciones y pautas globales con informaci\u00f3n predictiva.\u00a0<\/span><b><span data-contrast=\"none\">Combina documentaci\u00f3n inteligente, flujos de trabajo automatizados y expertos integrados<\/span><\/b><span data-contrast=\"none\"> para permitir una adaptaci\u00f3n m\u00e1s r\u00e1pida, lo que en \u00faltima instancia reduce el riesgo operativo.<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1100861737 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<div class=\"row\"  id=\"row-599951189\">\n\n\t<div id=\"col-1293695223\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Preguntas frecuentes<\/h3>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1293695223 > .col-inner {\n  margin: 0px 0px -10px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1559548901\" 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=\"text-3348359949\" class=\"text\">\n\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW204898813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW204898813 BCX0\">\u00bfQu\u00e9 es el Reglamento BPOM No. 23 de 2025?<\/span><\/span><\/h4>\n\t\t\n<style>\n#text-3348359949 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW204898813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW204898813 BCX0\">Se trata de una enmienda a las normas de registro de medicamentos de Indonesia, que actualiza los plazos de evaluaci\u00f3n, las definiciones de productos y los requisitos de etiquetado, que entrar\u00e1 en vigor el 12 de agosto de 2025.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1559548901 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-40336154\" 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=\"text-2269195585\" class=\"text\">\n\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW30300959 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW30300959 BCX0\">\u00bfCu\u00e1les son los nuevos plazos de evaluaci\u00f3n para el registro de medicamentos?<\/span><\/span><span class=\"LineBreakBlob BlobObject DragDrop SCXW30300959 BCX0\"><span class=\"SCXW30300959 BCX0\">\u00a0<\/span><br class=\"SCXW30300959 BCX0\" \/><\/span><\/h4>\n\t\t\n<style>\n#text-2269195585 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW52725570 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW52725570 BCX0\">La autorizaci\u00f3n de uso de emergencia para medicamentos gen\u00e9ricos ahora sigue una revisi\u00f3n de cinco d\u00edas, mientras que los nuevos medicamentos hu\u00e9rfanos o potencialmente mortales se eval\u00faan dentro de\u00a0<\/span><span class=\"NormalTextRun SCXW52725570 BCX0\">100 d\u00edas<\/span><span class=\"NormalTextRun SCXW52725570 BCX0\">.<\/span><\/span><span class=\"EOP SCXW52725570 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-40336154 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-463224301\" 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=\"text-599703478\" class=\"text\">\n\t\t\n<h4><span class=\"LineBreakBlob BlobObject DragDrop SCXW30300959 BCX0\"><span class=\"SCXW30300959 BCX0\"><span class=\"NormalTextRun SCXW206806883 BCX0\">\u00bfQu\u00e9 son los cambios de etiquetado?\u00a0<\/span><span class=\"NormalTextRun SCXW206806883 BCX0\">requerido<\/span><span class=\"NormalTextRun SCXW206806883 BCX0\">?<\/span> <\/span><br class=\"SCXW30300959 BCX0\" \/><\/span><\/h4>\n\t\t\n<style>\n#text-599703478 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW151548071 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW151548071 BCX0\">Las etiquetas ahora deben incluir detalles como\u00a0<\/span><span class=\"NormalTextRun SCXW151548071 BCX0\">vencimiento<\/span><span class=\"NormalTextRun SCXW151548071 BCX0\">\u00a0fechas despu\u00e9s de la apertura o reconstituci\u00f3n para ciertas formas de dosificaci\u00f3n como gotas para los ojos y polvos liofilizados.<\/span><\/span><span class=\"EOP SCXW151548071 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-463224301 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1389679660\" 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=\"text-11799161\" class=\"text\">\n\t\t\n<h4><span class=\"LineBreakBlob BlobObject DragDrop SCXW30300959 BCX0\"><span class=\"NormalTextRun SCXW99105432 BCX0\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW99105432 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW99105432 BCX0\">\u00a0\u00bfApoyar a las empresas con el cumplimiento de BPOM?<\/span><\/span><\/h4>\n\t\t\n<style>\n#text-11799161 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a class=\"Hyperlink SCXW54028281 BCX0\" href=\"https:\/\/regask.com\/es\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW54028281 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW54028281 BCX0\" data-ccp-charstyle=\"Hyperlink\">RegASK<\/span><\/span><\/a><span class=\"TextRun SCXW54028281 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54028281 BCX0\">\u00a0ayuda a los equipos reguladores\u00a0<\/span><span class=\"NormalTextRun SCXW54028281 BCX0\">monitor<\/span><span class=\"NormalTextRun SCXW54028281 BCX0\">\u00a0actualizaciones, agilizar la documentaci\u00f3n y garantizar\u00a0<\/span><span class=\"NormalTextRun SCXW54028281 BCX0\">oportuno<\/span><span class=\"NormalTextRun SCXW54028281 BCX0\">\u00a0cumplimiento del etiquetado seg\u00fan la nueva reglamentaci\u00f3n.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1389679660 > .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 Reglamento n.\u00ba 23 de 2025, publicado el 19 de agosto de 2025 por la Agencia Nacional de Control de Medicamentos y Alimentos de Indonesia (BPOM), introduce importantes modificaciones a los criterios y procedimientos de registro de medicamentos. El reglamento actualiza los plazos de evaluaci\u00f3n, aclara la clasificaci\u00f3n de los productos biol\u00f3gicos y ajusta los requisitos de etiquetado para alinearlos con las normas internacionales.\u00a0<\/p>","protected":false},"author":32,"featured_media":8713,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,517,35],"tags":[],"class_list":["post-8712","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-indonesia-regulations","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Indonesia BPOM Revises Drug Registration Rules Overview | RegASK<\/title>\n<meta name=\"description\" content=\"Indonesia&#039;s BPOM has updated drug registration rules. 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