{"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":"%e5%8a%a0%e6%8b%bf%e5%a4%a7%e5%8d%ab%e7%94%9f%e9%83%a8%e5%9f%ba%e5%9b%a0%e6%b2%bb%e7%96%97%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/health-canada-gene-therapy-guidelines\/","title":{"rendered":"\u52a0\u62ff\u5927\u536b\u751f\u90e8\u5b9e\u65bd\u975e\u4e34\u5e8a\u8bd5\u9a8c ICH \u6307\u5357\u2026"},"content":{"rendered":"<div>\n<div>\u52a0\u62ff\u5927\u536b\u751f\u90e8\u5ba3\u5e03\u5b9e\u65bd\u5173\u4e8e\u57fa\u56e0\u6cbb\u7597\u975e\u4e34\u5e8a\u751f\u7269\u5206\u5e03\u8003\u8651\u7684\u6307\u5357S12\u3002<\/div>\n<\/div>\n<div><\/div>\n<div>\u6839\u636e ICH \u7684\u6307\u5bfc\u65b9\u9488<\/div>\n<ul>\n<li>\u4e3a\u57fa\u56e0\u6cbb\u7597\uff08GT\uff09\u4ea7\u54c1\u5f00\u53d1\u4e2d\u5f00\u5c55\u975e\u4e34\u5e8a\u751f\u7269\u5206\u5e03\uff08BD\uff09\u7814\u7a76\u63d0\u4f9b\u7edf\u4e00\u7684\u5efa\u8bae\uff1b<\/li>\n<li>\u5305\u62ec\u6839\u636e 3R\uff08\u51cf\u5c11\/\u6539\u8fdb\/\u66ff\u4ee3\uff09\u539f\u5219\u4fc3\u8fdb GT \u4ea7\u54c1\u5f00\u53d1\u540c\u65f6\u907f\u514d\u4e0d\u5fc5\u8981\u5730\u4f7f\u7528\u52a8\u7269\u7684\u5efa\u8bae\uff1b<\/li>\n<li>\u4e3a\u975e\u4e34\u5e8a BD \u8bc4\u4f30\u7684\u603b\u4f53\u8bbe\u8ba1\u63d0\u51fa\u5efa\u8bae\u3002<\/li>\n<\/ul>\n<p>\u9700\u8981\u4e86\u89e3\u66f4\u591a\u6709\u5173\u6cbb\u7597\u4ea7\u54c1\u6cd5\u89c4\u53d8\u5316\u7684\u4fe1\u606f\u5417\uff1f <a href=\"https:\/\/regask.com\/zh\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" rel=\"noopener\">\u4e0e RegASK \u7684\u4e13\u5bb6\u53d6\u5f97\u8054\u7cfb\u3002<\/a><\/p>\n<a href=\"https:\/\/regask.com\/zh\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u66f4\u591a\u8be6\u60c5\u8bf7\u8054\u7cfb RegASK<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/zh\/%e7%b1%bb%e5%88%ab\/%e6%9c%80%e6%96%b0%e8%a7%81%e8%a7%a3\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u66f4\u591a<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-727902106\">\n\n\t<div id=\"col-1950664917\" 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\/zh\/%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6-2\/%e8%b5%84%e6%ba%90-%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6-%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u533b\u7597\u5668\u68b0\u884c\u4e1a\u6848\u4f8b\u7814\u7a76<\/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. 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