{"id":35070,"date":"2025-06-11T23:05:17","date_gmt":"2025-06-11T15:05:17","guid":{"rendered":"https:\/\/flcube.com\/?p=35070"},"modified":"2025-06-11T23:05:18","modified_gmt":"2025-06-11T15:05:18","slug":"chinas-cde-seeks-feedback-on-advanced-therapy-medicinal-products-guidelines","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35070","title":{"rendered":"China&#8217;s CDE Seeks Feedback on Advanced Therapy Medicinal Products Guidelines"},"content":{"rendered":"\n<p>China&#8217;s Center for Drug Evaluation (CDE) released a draft guideline titled &#8220;Scope, Classification and Definitions of Advanced Therapy Medicinal Products (ATMPs)&#8221; for public consultation until July 10, 2025. This marks a significant step toward standardizing the regulatory framework for innovative therapies.<\/p>\n\n\n\n<p><strong>Definition and Scope of ATMPs<\/strong><br>The draft defines ATMPs as cell therapeutic drugs and gene therapy drugs developed, manufactured, distributed, used, and regulated as pharmaceutical products under Chinese law. These products are produced via in vitro manipulation and exert intended functions in humans. It also includes other drugs produced through innovative microbial, cellular, genetic, or tissue-engineering technologies.<\/p>\n\n\n\n<p><strong>Global Consistency<\/strong><br>Aligning with international standards, the CDE adopts the term &#8220;ATMPs,&#8221; consistent with the European Medicines Agency (EMA) and the World Health Organization (WHO), differing from the FDA&#8217;s &#8220;Cellular and Gene Therapy Products (CGTs)&#8221; and Japan&#8217;s &#8220;Regenerative Medicinal Products (RMPs).&#8221; Preventive vaccines and conventional microbiome products, such as probiotics, are explicitly excluded from this definition.<\/p>\n\n\n\n<p><strong>Inclusion Criteria<\/strong><br>Xenogeneic-cell, tissue, or organ-derived products, such as gene-edited porcine organs for transplantation, qualify as ATMPs if they rely on biological activity, immune modulation, or tissue regeneration. Additionally, synthetic biology-based products may be included if they meet the technical criteria for ATMPs.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/\u300a\u5148\u8fdb\u6cbb\u7597\u836f\u54c1\u7684\u8303\u56f4\u3001\u5f52\u7c7b\u548c\u91ca\u4e49\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u300a\u5148\u8fdb\u6cbb\u7597\u836f\u54c1\u7684\u8303\u56f4\u3001\u5f52\u7c7b\u548c\u91ca\u4e49\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b.\"><\/object><a id=\"wp-block-file--media-8a58e398-6d51-40a1-ad07-7704695ad8ea\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/\u300a\u5148\u8fdb\u6cbb\u7597\u836f\u54c1\u7684\u8303\u56f4\u3001\u5f52\u7c7b\u548c\u91ca\u4e49\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b.pdf\">\u300a\u5148\u8fdb\u6cbb\u7597\u836f\u54c1\u7684\u8303\u56f4\u3001\u5f52\u7c7b\u548c\u91ca\u4e49\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/\u300a\u5148\u8fdb\u6cbb\u7597\u836f\u54c1\u7684\u8303\u56f4\u3001\u5f52\u7c7b\u548c\u91ca\u4e49\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-8a58e398-6d51-40a1-ad07-7704695ad8ea\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China&#8217;s Center for Drug Evaluation (CDE) released a draft guideline titled &#8220;Scope, Classification and Definitions&#8230;<\/p>\n","protected":false},"author":1,"featured_media":35071,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[4],"tags":[102],"class_list":["post-35070","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy-regulatory","tag-cde"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>China&#039;s CDE Seeks Feedback on Advanced Therapy Medicinal Products Guidelines - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China&#039;s Center for Drug Evaluation (CDE) released a draft guideline titled &quot;Scope, Classification and Definitions of Advanced Therapy Medicinal Products (ATMPs)&quot; for public consultation until July 10, 2025. 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