{"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":"%e3%82%ab%e3%83%8a%e3%83%80%e4%bf%9d%e5%81%a5%e7%9c%81%e9%81%ba%e4%bc%9d%e5%ad%90%e6%b2%bb%e7%99%82%e3%82%ac%e3%82%a4%e3%83%89%e3%83%a9%e3%82%a4%e3%83%b3","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/health-canada-gene-therapy-guidelines\/","title":{"rendered":"\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u3001\u975e\u81e8\u5e8a\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b ICH \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u5b9f\u65bd"},"content":{"rendered":"<div>\n<div>\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u306f\u3001\u907a\u4f1d\u5b50\u6cbb\u7642\u306b\u304a\u3051\u308b\u975e\u81e8\u5e8a\u751f\u4f53\u5185\u5206\u5e03\u306e\u8003\u616e\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 S12 \u306e\u5b9f\u65bd\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002<\/div>\n<\/div>\n<div><\/div>\n<div>ICH\u306b\u3088\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/div>\n<ul>\n<li>\u907a\u4f1d\u5b50\u6cbb\u7642\uff08GT\uff09\u88fd\u54c1\u306e\u958b\u767a\u306b\u304a\u3051\u308b\u975e\u81e8\u5e8a\u751f\u4f53\u5185\u5206\u5e03\uff08BD\uff09\u7814\u7a76\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u7d71\u4e00\u3055\u308c\u305f\u63a8\u5968\u4e8b\u9805\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/li>\n<li>3R\uff08\u524a\u6e1b\u30fb\u7cbe\u88fd\u30fb\u7f6e\u304d\u63db\u3048\uff09\u306e\u539f\u5247\u306b\u5f93\u3044\u3001\u52d5\u7269\u306e\u4e0d\u5fc5\u8981\u306a\u4f7f\u7528\u3092\u907f\u3051\u306a\u304c\u3089GT\u88fd\u54c1\u306e\u958b\u767a\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306e\u63a8\u5968\u4e8b\u9805\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>\u975e\u81e8\u5e8a BD \u8a55\u4fa1\u306e\u5168\u4f53\u7684\u306a\u8a2d\u8a08\u306b\u95a2\u3059\u308b\u63a8\u5968\u4e8b\u9805\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>\u6cbb\u7642\u88fd\u54c1\u306e\u898f\u5236\u5909\u66f4\u306b\u3064\u3044\u3066\u3055\u3089\u306b\u8a73\u3057\u304f\u77e5\u308a\u305f\u3044\u3067\u3059\u304b? <a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" rel=\"noopener\">RegASK \u306e\u5c02\u9580\u5bb6\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/a><\/p>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306fRegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/ja\/%e3%82%ab%e3%83%86%e3%82%b4%e3%83%aa\/%e6%9c%80%e6%96%b0%e3%81%ae%e6%b4%9e%e5%af%9f\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-412168393\">\n\n\t<div id=\"col-1036090148\" 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\/ja\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-2\/%e3%83%aa%e3%82%bd%e3%83%bc%e3%82%b9-%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3092\u8aad\u3080<\/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, in accordance with the 3Rs (reduce\/refine\/replace) principles; Makes recommendations for the overall design of nonclinical BD assessments. Need to know more about Therapy Products regulation changes? Get in touch with RegASK\u2019s experts.<\/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 v27.3 (Yoast SEO v27.4) - 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. 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Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u907a\u4f1d\u5b50\u6cbb\u7642\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\/\" \/>\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=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u5206\" \/>\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\":\"ja\"},{\"@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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