{"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":"guia-de-registro-de-productos-biologicos-del-cde-de-china","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/china-cde-biologics-registration-guide\/","title":{"rendered":"CDE (China) publica directrices para el registro de productos biol\u00f3gicos\u2026"},"content":{"rendered":"<p data-start=\"151\" data-end=\"567\">El 9 de febrero de 2025, el Centro de Evaluaci\u00f3n de Medicamentos (CDE) anunci\u00f3 el lanzamiento de la <strong data-start=\"238\" data-end=\"318\">\u201cDirectriz para la Revisi\u00f3n de Aceptaci\u00f3n del Registro de Productos Biol\u00f3gicos (Ensayo)\u201d<\/strong> (No. 15 de 2025), que entrar\u00e1 en vigor el <strong data-start=\"359\" data-end=\"377\">10 de marzo de 2025<\/strong>Esta importante actualizaci\u00f3n tiene como objetivo <strong data-start=\"411\" data-end=\"452\">estandarizar el proceso de revisi\u00f3n formal<\/strong> para la aceptaci\u00f3n del registro de productos biol\u00f3gicos, ofreciendo una orientaci\u00f3n m\u00e1s clara a los solicitantes para garantizar el cumplimiento normativo.<\/p>\n<p data-start=\"569\" data-end=\"611\">Los aspectos m\u00e1s destacados de la directriz incluyen:<\/p>\n<ul data-start=\"613\" data-end=\"992\">\n<li data-start=\"613\" data-end=\"724\"><strong data-start=\"615\" data-end=\"650\">Requisitos de presentaci\u00f3n refinados<\/strong> para agilizar la revisi\u00f3n de aceptaci\u00f3n del registro de productos biol\u00f3gicos.<\/li>\n<li data-start=\"725\" data-end=\"862\">Aplicabilidad a <strong data-start=\"744\" data-end=\"785\">todas las categor\u00edas de productos biol\u00f3gicos<\/strong>, lo que obliga a los fabricantes y desarrolladores a reevaluar las estrategias de cumplimiento.<\/li>\n<li data-start=\"863\" data-end=\"992\">Un <strong data-start=\"868\" data-end=\"909\">fecha de implementaci\u00f3n del 10 de marzo de 2025<\/strong>, dando tiempo a las partes interesadas para alinear su documentaci\u00f3n con los nuevos est\u00e1ndares.<\/li>\n<\/ul>\n<p data-start=\"994\" data-end=\"1216\">Esta iniciativa regulatoria refleja el compromiso continuo del CDE con <strong data-start=\"1058\" data-end=\"1104\">Mejorar la supervisi\u00f3n y la claridad regulatoria<\/strong> dentro del sector de productos biol\u00f3gicos, lo que podr\u00eda afectar los plazos de desarrollo de productos y las estrategias de entrada al mercado.<\/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 v27.6 (Yoast SEO v27.6) - 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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