{"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":"richtlinien-fur-gentherapie-von-health-canada","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/health-canada-gene-therapy-guidelines\/","title":{"rendered":"Health Canada implementiert ICH-Leitlinie zu nichtklinischen B\u2026"},"content":{"rendered":"<div>\n<div>Health Canada hat die Umsetzung der Leitlinie S12 zu nichtklinischen \u00dcberlegungen zur Bioverteilung bei Gentherapien angek\u00fcndigt.<\/div>\n<\/div>\n<div><\/div>\n<div>Die Leitlinie nach ICH<\/div>\n<ul>\n<li>Bietet harmonisierte Empfehlungen f\u00fcr die Durchf\u00fchrung nichtklinischer Bioverteilungsstudien (BD) bei der Entwicklung von Gentherapieprodukten (GT);<\/li>\n<li>Enth\u00e4lt Empfehlungen zur Erleichterung der Entwicklung von GT-Produkten bei gleichzeitiger Vermeidung unn\u00f6tiger Tierversuche gem\u00e4\u00df den 3R-Prinzipien (Reduzieren\/Verfeinern\/Ersetzen);<\/li>\n<li>Gibt Empfehlungen f\u00fcr die Gesamtgestaltung nichtklinischer BD-Beurteilungen.<\/li>\n<\/ul>\n<p>M\u00f6chten Sie mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Therapieprodukte erfahren? <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/p>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/de\/kategorie\/neuesten-erkenntnisse\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1327317452\">\n\n\t<div id=\"col-1983843891\" 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\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/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 v28.4 (Yoast SEO v28.5) - 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\/de\/richtlinien-fur-gentherapie-von-health-canada\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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\/de\/richtlinien-fur-gentherapie-von-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\u00a0Minute\" \/>\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\":\"de\"},{\"@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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