{"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>Le 9 f\u00e9vrier 2025, le Centre d\u2019\u00e9valuation des m\u00e9dicaments (CDE) a annonc\u00e9 la publication des \u201c\u00a0Lignes directrices pour l\u2019examen d\u2019acceptation des demandes d\u2019enregistrement de produits biologiques (version d\u2019essai)\u00a0\u201d (n\u00b0\u00a015 de 2025), qui entreront en vigueur le 10 mars 2025. Cette importante mise \u00e0 jour vise \u00e0 standardiser le processus d\u2019examen formel pour l\u2019acceptation des demandes d\u2019enregistrement de produits biologiques, en offrant des orientations plus claires aux demandeurs\u2026<\/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 v28.4 (Yoast SEO v28.4) - 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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