{"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>El 9 de febrero de 2025, el Centro de Evaluaci\u00f3n de Medicamentos (CDE) anunci\u00f3 la publicaci\u00f3n de la \u201cGu\u00eda para la Revisi\u00f3n de Aceptaci\u00f3n del Registro de Productos Biol\u00f3gicos (Prueba)\u201d (n.\u00b0 15 de 2025), que entrar\u00e1 en vigor el 10 de marzo de 2025. Esta importante actualizaci\u00f3n tiene como objetivo estandarizar el proceso formal de revisi\u00f3n para la aceptaci\u00f3n del registro de productos biol\u00f3gicos, ofreciendo una gu\u00eda m\u00e1s clara para los solicitantes\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 v28.5) - 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. 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