{"id":31411,"date":"2023-12-15T16:47:01","date_gmt":"2023-12-15T15:47:01","guid":{"rendered":"https:\/\/www.thema-med.com\/2023\/12\/15\/australia-requisiti-piu-chiari-per-la-valutazione-clinica\/"},"modified":"2023-12-15T16:50:31","modified_gmt":"2023-12-15T15:50:31","slug":"australia-requisiti-piu-chiari-per-la-valutazione-clinica","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2023\/12\/15\/australia-requisiti-piu-chiari-per-la-valutazione-clinica\/","title":{"rendered":"AUSTRALIA: requisitos m\u00e1s claros para la evaluaci\u00f3n cl\u00ednica"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>El 23 de noviembre, la Therapeutic Good Administration <strong>(TGA)<\/strong> public\u00f3 la revisi\u00f3n de la directriz <a href=\"https:\/\/www.tga.gov.au\/sites\/default\/files\/2023-11\/clinical-evidence-guidelines-medical-devices-v3-2.pdf\"><em>Clinical evidence guidelines Version 3.2<\/em><\/a>, en la que se establecen los <strong>requisitos en materia de pruebas cl\u00ednicas<\/strong> para los productos sanitarios y los de diagn\u00f3stico in vitro.<\/h2>\n<p>La directriz pretende ser un <strong>punto de referencia<\/strong> com\u00fan tanto para la industria como para la Autoridad Reguladora, ayudando a Patrocinadores y Fabricantes a recopilar, compilar y presentar pruebas cl\u00ednicas para cumplir los requisitos australianos, introduciendo nuevos cap\u00edtulos sobre <strong>productos<\/strong> <strong>oft\u00e1lmicos<\/strong> y <strong>productos sanitarios que incorporan un medicamento<\/strong> y modificaciones de <strong>implantes mamarios<\/strong> y <strong>expansores de tejidos<\/strong>. Tambi\u00e9n se han a\u00f1adido referencias a <strong>datos<\/strong> y <strong>pruebas<\/strong>.<\/p>\n<p>Por lo que respecta a <strong>los productos oft\u00e1lmicos<\/strong>, la secci\u00f3n de referencia ofrece orientaci\u00f3n sobre la naturaleza y el tipo de pruebas cl\u00ednicas que se esperan en general para demostrar el cumplimiento de las disposiciones pertinentes de los Principios Esenciales.<\/p>\n<p>La secci\u00f3n sobre productos sanitarios <strong>basados en sustancias<\/strong> ofrece orientaci\u00f3n sobre las expectativas en relaci\u00f3n con los productos que incorporan, como parte integrante, sustancias que, si se utilizaran por separado, constituir\u00edan medicamentos y es probable que actuaran en el cuerpo del paciente con una acci\u00f3n accesoria a la del producto.<\/p>\n<p>En cuanto a los implantes mamarios y los expansores de tejidos, la directriz abarca <strong>los implantes mamarios<\/strong> rellenos de soluci\u00f3n salina, gel de silicona o substancias alternativas destinados al aumento o la reconstrucci\u00f3n mamaria, y considera <strong>los expansores de tejidos<\/strong> utilizados en la reconstrucci\u00f3n mamaria.<\/p>\n<p>La secci\u00f3n de referencia sobre datos y pruebas ofrece recomendaciones resumidas, definiciones y pruebas necesarias relativas a las investigaciones cl\u00ednicas. Por lo que respecta a los datos y las pruebas, los datos cl\u00ednicos pueden generarse para el propio producto o para un producto comparable e incluyen datos procedentes de investigaciones cl\u00ednicas, revisi\u00f3n bibliogr\u00e1fica, datos posteriores a la comercializaci\u00f3n y otros datos de experiencia cl\u00ednica.<\/p>\n<p>La revisi\u00f3n de la directriz por parte de la TGA pretende actualizar el <strong>marco normativo<\/strong> australiano para seguir el ritmo de otros pa\u00edses del mundo, como EE.\u00a0UU. y China, regulando dispositivos como los basados en sustancias, cada vez m\u00e1s utilizados.<\/p>\n<p>&gt;&gt; A trav\u00e9s de los servicios de\u00a0<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>consultor\u00eda estrat\u00e9gica-normativa<\/strong><\/a> Thema apoya el<strong>\u00a0<\/strong><a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/\"><strong>registro en la Therapeutic Good Administration<\/strong><\/a> para la comercializaci\u00f3n de productos sanitarios y de diagn\u00f3stico in vitro en Australia.<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/www.tga.gov.au\/sites\/default\/files\/2023-11\/clinical-evidence-guidelines-medical-devices-v3-2.pdf\">Clinical evidence guidelines Version 3.2<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":31406,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-31411","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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