{"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":"guide-denregistrement-des-produits-biologiques-du-cde-chinois","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/china-cde-biologics-registration-guide\/","title":{"rendered":"Le CDE (Chine) publie des lignes directrices pour l&#039;enregistrement des produits biologiques\u2026"},"content":{"rendered":"<p data-start=\"151\" data-end=\"567\">Le 9 f\u00e9vrier 2025, le Center for Drug Evaluation (CDE) a annonc\u00e9 la sortie du <strong data-start=\"238\" data-end=\"318\">\u00ab\u00a0Lignes directrices pour l&#039;examen d&#039;acceptation de l&#039;enregistrement des produits biologiques (essai)\u00a0\u00bb<\/strong> (n\u00b0 15 de 2025), qui devrait entrer en vigueur le <strong data-start=\"359\" data-end=\"377\">10 mars 2025<\/strong>Cette mise \u00e0 jour importante vise \u00e0 <strong data-start=\"411\" data-end=\"452\">normaliser le processus d&#039;examen formel<\/strong> pour l&#039;acceptation de l&#039;enregistrement des produits biologiques, offrant des conseils plus clairs aux candidats afin de garantir la conformit\u00e9 r\u00e9glementaire.<\/p>\n<p data-start=\"569\" data-end=\"611\">Les principaux points saillants de la ligne directrice comprennent :<\/p>\n<ul data-start=\"613\" data-end=\"992\">\n<li data-start=\"613\" data-end=\"724\"><strong data-start=\"615\" data-end=\"650\">Exigences de soumission affin\u00e9es<\/strong> pour rationaliser l\u2019examen d\u2019acceptation de l\u2019enregistrement des produits biologiques.<\/li>\n<li data-start=\"725\" data-end=\"862\">Applicabilit\u00e9 \u00e0 <strong data-start=\"744\" data-end=\"785\">toutes les cat\u00e9gories de produits biologiques<\/strong>, obligeant les fabricants et les d\u00e9veloppeurs \u00e0 r\u00e9\u00e9valuer leurs strat\u00e9gies de conformit\u00e9.<\/li>\n<li data-start=\"863\" data-end=\"992\">Un <strong data-start=\"868\" data-end=\"909\">date de mise en \u0153uvre du 10 mars 2025<\/strong>, laissant aux parties prenantes le temps d\u2019aligner leur documentation sur les nouvelles normes.<\/li>\n<\/ul>\n<p data-start=\"994\" data-end=\"1216\">Cette initiative r\u00e9glementaire refl\u00e8te l\u2019engagement continu du CDE \u00e0 <strong data-start=\"1058\" data-end=\"1104\">am\u00e9liorer la surveillance et la clart\u00e9 r\u00e9glementaire<\/strong> au sein du secteur des produits biologiques, ce qui pourrait avoir un impact sur les d\u00e9lais de d\u00e9veloppement des produits et les strat\u00e9gies d\u2019entr\u00e9e sur le march\u00e9.<\/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":43,"featured_media":8110,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[514,35],"tags":[496,498,609],"class_list":["post-8048","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-china-regulations","category-pharma-biotech-latest-insights","tag-market-authorization-regs","tag-drug-development-regs","tag-guideline"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - 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. 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