{"id":8048,"date":"2025-03-06T19:30:50","date_gmt":"2025-03-06T11:30:50","guid":{"rendered":"https:\/\/regask.com\/?p=8048"},"modified":"2025-03-10T19:33:39","modified_gmt":"2025-03-10T11:33:39","slug":"%e4%b8%ad%e5%9b%bdcde%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81%e6%b3%a8%e5%86%8c%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/china-cde-biologics-registration-guide\/","title":{"rendered":"\u4e2d\u56fd\u836f\u5ba1\u4e2d\u5fc3\u53d1\u5e03\u751f\u7269\u5236\u54c1\u6ce8\u518c\u7ba1\u7406\u6307\u5357\u2026"},"content":{"rendered":"<p data-start=\"151\" data-end=\"567\">2025\u5e742\u67089\u65e5\uff0c\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u5ba3\u5e03\u53d1\u5e03 <strong data-start=\"238\" data-end=\"318\">\u300a\u751f\u7269\u5236\u54c1\u6ce8\u518c\u53d7\u7406\u5ba1\u67e5\u6307\u5bfc\u539f\u5219\uff08\u8bd5\u884c\uff09\u300b<\/strong> \uff082025 \u5e74\u7b2c 15 \u53f7\uff09\uff0c\u5c06\u4e8e <strong data-start=\"359\" data-end=\"377\">2025 \u5e74 3 \u6708 10 \u65e5<\/strong>\u3002\u672c\u6b21\u91cd\u5927\u66f4\u65b0\u65e8\u5728 <strong data-start=\"411\" data-end=\"452\">\u6807\u51c6\u5316\u6b63\u5f0f\u5ba1\u67e5\u6d41\u7a0b<\/strong> \u7528\u4e8e\u751f\u7269\u5236\u54c1\u6ce8\u518c\u53d7\u7406\uff0c\u4e3a\u7533\u8bf7\u4eba\u63d0\u4f9b\u66f4\u660e\u786e\u7684\u6307\u5bfc\uff0c\u4ee5\u786e\u4fdd\u9075\u5b88\u6cd5\u89c4\u3002<\/p>\n<p data-start=\"569\" data-end=\"611\">\u8be5\u6307\u5357\u7684\u4e3b\u8981\u4eae\u70b9\u5305\u62ec\uff1a<\/p>\n<ul data-start=\"613\" data-end=\"992\">\n<li data-start=\"613\" data-end=\"724\"><strong data-start=\"615\" data-end=\"650\">\u5b8c\u5584\u63d0\u4ea4\u8981\u6c42<\/strong> \u7b80\u5316\u751f\u7269\u5236\u54c1\u6ce8\u518c\u53d7\u7406\u5ba1\u67e5\u3002<\/li>\n<li data-start=\"725\" data-end=\"862\">\u9002\u7528\u8303\u56f4 <strong data-start=\"744\" data-end=\"785\">\u6240\u6709\u7c7b\u522b\u7684\u751f\u7269\u5236\u54c1<\/strong>\uff0c\u8981\u6c42\u5236\u9020\u5546\u548c\u5f00\u53d1\u5546\u91cd\u65b0\u8bc4\u4f30\u5408\u89c4\u7b56\u7565\u3002<\/li>\n<li data-start=\"863\" data-end=\"992\">\u4e00\u4e2a <strong data-start=\"868\" data-end=\"909\">\u5b9e\u65bd\u65e5\u671f\uff1a2025\u5e743\u670810\u65e5<\/strong>\uff0c\u8ba9\u5229\u76ca\u76f8\u5173\u8005\u6709\u65f6\u95f4\u4f7f\u4ed6\u4eec\u7684\u6587\u6863\u7b26\u5408\u65b0\u6807\u51c6\u3002<\/li>\n<\/ul>\n<p data-start=\"994\" data-end=\"1216\">\u8fd9\u4e00\u76d1\u7ba1\u4e3e\u63aa\u4f53\u73b0\u4e86 CDE \u5bf9 <strong data-start=\"1058\" data-end=\"1104\">\u52a0\u5f3a\u76d1\u7763\u548c\u76d1\u7ba1\u900f\u660e\u5ea6<\/strong> \u5728\u751f\u7269\u5236\u5242\u9886\u57df\uff0c\u53ef\u80fd\u4f1a\u5f71\u54cd\u4ea7\u54c1\u5f00\u53d1\u65f6\u95f4\u8868\u548c\u5e02\u573a\u8fdb\u5165\u7b56\u7565\u3002<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>On February 9, 2025, the Center for Drug Evaluation (CDE) announced the release of the &#8220;Guideline for Acceptance Review of Biological Product Registration (Trial)&#8221; (No. 15 of 2025), set to take effect on March 10, 2025. This significant update aims to standardize the formal review process for biologics registration acceptance, offering clearer guidance for applicants&#8230;<\/p>","protected":false},"author":30,"featured_media":8110,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[514,35],"tags":[609,498,496],"class_list":["post-8048","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-china-regulations","category-pharma-biotech-latest-insights","tag-guideline","tag-drug-development-regs","tag-market-authorization-regs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>China CDE Issues Biologics Registration Guideline | RegASK<\/title>\n<meta name=\"description\" content=\"China CDE releases new guidelines to streamline biologics registration. Effective March 10, 2025. Read more at 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\/zh\/\u4e2d\u56fdcde\u751f\u7269\u5236\u54c1\u6ce8\u518c\u6307\u5357\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CDE (China) Publishes Guideline for Biologics Registration Acceptance to Enhance Compliance\" \/>\n<meta property=\"og:description\" content=\"China CDE releases new guidelines to streamline biologics registration. Effective March 10, 2025. Read more at RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/\u4e2d\u56fdcde\u751f\u7269\u5236\u54c1\u6ce8\u518c\u6307\u5357\/\" \/>\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=\"2025-03-06T11:30:50+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-10T11:33:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/03\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Amandine Tricou\" \/>\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=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Amandine Tricou\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\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\\\/china-cde-biologics-registration-guide\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/\"},\"author\":{\"name\":\"Amandine Tricou\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c2135b6dbdb95b0886564618fe9f4108\"},\"headline\":\"CDE (China) Publishes Guideline for Biologics Registrat&hellip;\",\"datePublished\":\"2025-03-06T11:30:50+00:00\",\"dateModified\":\"2025-03-10T11:33:39+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/\"},\"wordCount\":141,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png\",\"keywords\":[\"Guideline\",\"Drug Development Regs\",\"Market authorization regs\"],\"articleSection\":[\"China\",\"Pharma and Biotech\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/\",\"name\":\"China CDE Issues Biologics Registration Guideline | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png\",\"datePublished\":\"2025-03-06T11:30:50+00:00\",\"dateModified\":\"2025-03-10T11:33:39+00:00\",\"description\":\"China CDE releases new guidelines to streamline biologics registration. Effective March 10, 2025. Read more at RegASK.\",\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/china-cde-biologics-registration-guide\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png\",\"width\":800,\"height\":600,\"caption\":\"Cde China Publishes Guideline Biologics Registration Acceptance Enhance Compliance\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/@RegASK\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c2135b6dbdb95b0886564618fe9f4108\",\"name\":\"Amandine Tricou\",\"sameAs\":[\"http:\\\/\\\/www.regask.com\"]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u4e2d\u56fd\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u53d1\u5e03\u751f\u7269\u5236\u54c1\u6ce8\u518c\u6307\u5357 | RegASK","description":"\u4e2d\u56fd\u836f\u5ba1\u4e2d\u5fc3\u53d1\u5e03\u65b0\u6307\u5357\u4ee5\u7b80\u5316\u751f\u7269\u5236\u5242\u6ce8\u518c\u3002\u81ea 2025 \u5e74 3 \u6708 10 \u65e5\u8d77\u751f\u6548\u3002\u66f4\u591a\u4fe1\u606f\u8bf7\u9605\u8bfb RegASK\u3002","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/zh\/\u4e2d\u56fdcde\u751f\u7269\u5236\u54c1\u6ce8\u518c\u6307\u5357\/","og_locale":"zh_CN","og_type":"article","og_title":"CDE (China) Publishes Guideline for Biologics Registration Acceptance to Enhance Compliance","og_description":"China CDE releases new guidelines to streamline biologics registration. Effective March 10, 2025. Read more at RegASK.","og_url":"https:\/\/regask.com\/zh\/\u4e2d\u56fdcde\u751f\u7269\u5236\u54c1\u6ce8\u518c\u6307\u5357\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2025-03-06T11:30:50+00:00","article_modified_time":"2025-03-10T11:33:39+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2025\/03\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png","type":"image\/png"}],"author":"Amandine Tricou","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"\u4f5c\u8005":"Amandine Tricou","\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"1 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/#article","isPartOf":{"@id":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/"},"author":{"name":"Amandine Tricou","@id":"https:\/\/regask.com\/#\/schema\/person\/c2135b6dbdb95b0886564618fe9f4108"},"headline":"CDE (China) Publishes Guideline for Biologics Registrat&hellip;","datePublished":"2025-03-06T11:30:50+00:00","dateModified":"2025-03-10T11:33:39+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/"},"wordCount":141,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/03\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png","keywords":["Guideline","Drug Development Regs","Market authorization regs"],"articleSection":["China","Pharma and Biotech"],"inLanguage":"zh-Hans"},{"@type":"WebPage","@id":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/","url":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/","name":"\u4e2d\u56fd\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u53d1\u5e03\u751f\u7269\u5236\u54c1\u6ce8\u518c\u6307\u5357 | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/03\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png","datePublished":"2025-03-06T11:30:50+00:00","dateModified":"2025-03-10T11:33:39+00:00","description":"\u4e2d\u56fd\u836f\u5ba1\u4e2d\u5fc3\u53d1\u5e03\u65b0\u6307\u5357\u4ee5\u7b80\u5316\u751f\u7269\u5236\u5242\u6ce8\u518c\u3002\u81ea 2025 \u5e74 3 \u6708 10 \u65e5\u8d77\u751f\u6548\u3002\u66f4\u591a\u4fe1\u606f\u8bf7\u9605\u8bfb RegASK\u3002","inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/china-cde-biologics-registration-guide\/"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/china-cde-biologics-registration-guide\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2025\/03\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/03\/cde-china-publishes-guideline-biologics-registration-acceptance-enhance-compliance.png","width":800,"height":600,"caption":"Cde China Publishes Guideline Biologics Registration Acceptance Enhance Compliance"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"\u52a9\u529b\u66f4\u660e\u667a\u7684\u76d1\u7ba1\u51b3\u7b56","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/@RegASK"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c2135b6dbdb95b0886564618fe9f4108","name":"\u963f\u66fc\u4e01\u00b7\u7279\u91cc\u5e93","sameAs":["http:\/\/www.regask.com"]}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/8048","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/users\/30"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/comments?post=8048"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/8048\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media\/8110"}],"wp:attachment":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media?parent=8048"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/categories?post=8048"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/tags?post=8048"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}