{"id":4341,"date":"2023-08-01T16:16:04","date_gmt":"2023-08-01T08:16:04","guid":{"rendered":"https:\/\/regask.com\/?p=4341"},"modified":"2024-10-26T02:56:36","modified_gmt":"2024-10-25T18:56:36","slug":"pautas-de-terapia-genica-de-health-canada","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/health-canada-gene-therapy-guidelines\/","title":{"rendered":"Health Canada implementa la directriz de la ICH sobre la atenci\u00f3n m\u00e9dica no cl\u00ednica"},"content":{"rendered":"<div>\n<div>Salud Canad\u00e1 ha anunciado la implementaci\u00f3n de la directriz S12 sobre consideraciones de biodistribuci\u00f3n no cl\u00ednica para la terapia g\u00e9nica.<\/div>\n<\/div>\n<div><\/div>\n<div>La directriz seg\u00fan la ICH<\/div>\n<ul>\n<li>Proporciona recomendaciones armonizadas para la realizaci\u00f3n de estudios de biodistribuci\u00f3n (BD) no cl\u00ednicos en el desarrollo de productos de terapia g\u00e9nica (GT);<\/li>\n<li>Incluye recomendaciones para facilitar el desarrollo de productos GT evitando el uso innecesario de animales, de acuerdo con los principios de las 3R (reducir\/refinar\/reemplazar);<\/li>\n<li>Hace recomendaciones para el dise\u00f1o general de evaluaciones no cl\u00ednicas del trastorno bipolar.<\/li>\n<\/ul>\n<p>\u00bfNecesita saber m\u00e1s sobre los cambios en la regulaci\u00f3n de los productos terap\u00e9uticos? <a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/p>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/es\/categoria\/ultimos-conocimientos\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-2095772282\">\n\n\t<div id=\"col-1205437008\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria de dispositivos m\u00e9dicos<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene therapy. The guideline according to ICH Provides harmonized recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products; Includes recommendations to facilitate the development of GT products while avoiding unnecessary use of animals,&#8230;<\/p>","protected":false},"author":39,"featured_media":3003,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[513,39],"tags":[40],"class_list":["post-4341","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-canada-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Canada Adopts ICH Gene Therapy Guidelines | RegASK<\/title>\n<meta name=\"description\" content=\"Health Canada implements ICH guideline on nonclinical biodistribution considerations for gene therapy products. 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\/pautas-de-terapia-genica-de-health-canada\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Canada Implements ICH Guideline on Nonclinical Biodistribution Considerations for Gene Therapy Products\" \/>\n<meta property=\"og:description\" content=\"Health Canada implements ICH guideline on nonclinical biodistribution considerations for gene therapy products. Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/pautas-de-terapia-genica-de-health-canada\/\" \/>\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=\"2023-08-01T08:16:04+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-25T18:56:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\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\\\/health-canada-gene-therapy-guidelines\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Health Canada Implements ICH Guideline on Nonclinical B&hellip;\",\"datePublished\":\"2023-08-01T08:16:04+00:00\",\"dateModified\":\"2024-10-25T18:56:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/\"},\"wordCount\":167,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Canada\",\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/\",\"name\":\"Canada Adopts ICH Gene Therapy Guidelines | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"datePublished\":\"2023-08-01T08:16:04+00:00\",\"dateModified\":\"2024-10-25T18:56:36+00:00\",\"description\":\"Health Canada implements ICH guideline on nonclinical biodistribution considerations for gene therapy products. 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