{"id":4160,"date":"2023-03-21T09:42:33","date_gmt":"2023-03-21T01:42:33","guid":{"rendered":"https:\/\/regask.com\/?p=4160"},"modified":"2024-10-04T03:24:17","modified_gmt":"2024-10-03T19:24:17","slug":"evaluacion-de-nuevas-sustancias-de-la-tga","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/tga-new-substance-evaluation\/","title":{"rendered":"TGA introdujo cambios que se aplican a la evaluaci\u00f3n de nuevos..."},"content":{"rendered":"<div>\n<div><a href=\"https:\/\/www.tga.gov.au\/\" target=\"_blank\" rel=\"noopener\">La TGA<\/a> Ha introducido cambios con respecto a la evaluaci\u00f3n de nuevos ingredientes que se utilizar\u00e1n en medicamentos listados (AUST L) y listados evaluados (AUST L (A)).<\/div>\n<div><\/div>\n<div>Estos medicamentos solo pueden contener ingredientes incluidos en la Determinaci\u00f3n de Productos Terap\u00e9uticos (Ingredientes Permitidos). La TGA ha introducido requisitos obligatorios para las solicitudes de modificaci\u00f3n de la Determinaci\u00f3n de Ingredientes Permitidos en virtud de la secci\u00f3n 26BD de la Ley de Productos Terap\u00e9uticos de 1989 y las directrices que la acompa\u00f1an. Estas entraron en vigor el 1 de febrero de 2023 y solo se aplican a las nuevas solicitudes presentadas a partir de esta fecha.<\/div>\n<div><\/div>\n<div>Se ha modificado la categor\u00eda de solicitud de nueva sustancia IN1, lo que significa\u2026<\/div>\n<div><\/div>\n<div><strong>Puede encontrar m\u00e1s detalles sobre este documento en la Plataforma RegASK.\u00a0<\/strong><\/div>\n<\/div>\n<div class=\"slider-wrapper relative\" id=\"slider-1920959510\" >\n    <div class=\"slider slider-nav-circle slider-nav-large slider-nav-dark slider-style-normal\"\n        data-flickity-options='{            \"cellAlign\": \"center\",            \"imagesLoaded\": true,            \"lazyLoad\": 1,            \"freeScroll\": false,            \"wrapAround\": true,            \"autoPlay\": 4500,            \"pauseAutoPlayOnHover\" : true,            \"prevNextButtons\": true,            \"contain\" : true,            \"adaptiveHeight\" : true,            \"dragThreshold\" : 10,            \"percentPosition\": true,            \"pageDots\": false,            \"rightToLeft\": false,            \"draggable\": true,            \"selectedAttraction\": 0.1,            \"parallax\" : 0,            \"friction\": 0.6        }'\n        >\n        \n     <\/div>\n\n     <div class=\"loading-spin dark large centered\"><\/div>\n\n\t<\/div>\n\n\n\t<div id=\"gap-262055164\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-262055164 {\n  padding-top: 40px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_697734099\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-1177249950\">\n\n\t<div id=\"col-1952647376\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<section class=\"section\" id=\"section_1350370425\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1997603025\">\n\n\n\t<div id=\"col-33131604\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2>Lo sentimos, este contenido premium es solo para clientes de RegASK.<\/h2>\n<p>\u00bfQuieres acceder a todo el contenido de la alerta o navegar por todas las noticias?\u00a0<\/p>\n<div class=\"row\"  id=\"row-708223242\">\n\n\n\t<div id=\"col-677071755\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<a href=\"https:\/\/app.RegASK.com\/#\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Inicio de sesi\u00f3n del cliente<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/solicitar-una-demostracion\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>Reservar una demostraci\u00f3n<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Navegar por las noticias<\/span>\n\t<\/a>\n\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1350370425 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n<\/style>\n\t<\/section>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_697734099 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(0, 49, 117);\n}\n<\/style>\n\t<\/section>\n\t\n\t<div id=\"gap-1561186746\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1561186746 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>","protected":false},"excerpt":{"rendered":"<p>La TGA ha introducido cambios en relaci\u00f3n con la evaluaci\u00f3n de nuevos ingredientes que se utilizar\u00e1n en medicamentos listados (AUST L) y listados evaluados (AUST L (A)). Estos medicamentos solo pueden contener ingredientes incluidos en la Determinaci\u00f3n de productos terap\u00e9uticos (ingredientes permitidos). La TGA ha introducido requisitos obligatorios para las solicitudes de modificaci\u00f3n de la Determinaci\u00f3n de ingredientes permitidos en virtud del art\u00edculo\u2026<\/p>","protected":false},"author":39,"featured_media":3148,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[40,56],"class_list":["post-4160","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-latest-insights","tag-premium-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>TGA Updates New Substance Evaluation | RegASK<\/title>\n<meta name=\"description\" content=\"The TGA introduces changes to the evaluation of new substances for listed medicines. Stay compliant with RegASK.\" \/>\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\/es\/evaluacion-de-nuevas-sustancias-de-la-tga\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TGA Introduced Changes Applying to Evaluation of New Substances for Listed Medicines\" \/>\n<meta property=\"og:description\" content=\"The TGA introduces changes to the evaluation of new substances for listed medicines. Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/evaluacion-de-nuevas-sustancias-de-la-tga\/\" \/>\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=\"2023-03-21T01:42:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-03T19:24:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2022\/02\/pharma-giant-elevated-regulatory-change-monitoring-with-regalert.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1601\" \/>\n\t<meta property=\"og:image:height\" content=\"1201\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\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=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/tga-new-substance-evaluation\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-new-substance-evaluation\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"TGA Introduced Changes Applying to Evaluation of New Su&hellip;\",\"datePublished\":\"2023-03-21T01:42:33+00:00\",\"dateModified\":\"2024-10-03T19:24:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-new-substance-evaluation\\\/\"},\"wordCount\":144,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-new-substance-evaluation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/02\\\/pharma-giant-elevated-regulatory-change-monitoring-with-regalert.png\",\"keywords\":[\"Latest Insights\",\"Premium News\"],\"articleSection\":[\"Pharma and Biotech\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/tga-new-substance-evaluation\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/tga-new-substance-evaluation\\\/\",\"name\":\"TGA Updates New Substance Evaluation | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-new-substance-evaluation\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-new-substance-evaluation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/02\\\/pharma-giant-elevated-regulatory-change-monitoring-with-regalert.png\",\"datePublished\":\"2023-03-21T01:42:33+00:00\",\"dateModified\":\"2024-10-03T19:24:17+00:00\",\"description\":\"The TGA introduces changes to the evaluation of new substances for listed medicines. 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