{"id":40656,"date":"2018-03-06T08:38:51","date_gmt":"2018-03-06T13:38:51","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/drug-establishments-must-use-ectd-format-for-u-s-fda-drug-master-file-dmf-submissions-beginning-may-5-2018\/"},"modified":"2020-02-06T20:55:57","modified_gmt":"2020-02-06T20:55:57","slug":"drug-establishments-must-use-ectd-format-for-u-s-fda-drug-master-file-dmf-submissions-beginning-may-5-2018","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/es\/drug-establishments-must-use-ectd-format-for-u-s-fda-drug-master-file-dmf-submissions-beginning-may-5-2018\/","title":{"rendered":"A Partir del 5 de Mayo de 2018, los Establecimientos Farmac\u00e9uticos Deben Utilizar el Formato eCTD para Todas las Presentaciones de Drug Master Files (DMF)"},"content":{"rendered":"<p>A partir del 5 de Mayo de 2018, la Administraci\u00f3n de Alimentos y Medicamentos (FDA) de los Estados Unidos requerir\u00e1 el formato \u201celectronic common technical document\u201d (eCTD) para cualquier presentaci\u00f3n nueva de Drug Master File (DMF), incluyendo reportes y modificaciones.<\/p>\n<p><strong>\u00bfQu\u00e9 es el eCTD?<\/strong><\/p>\n<p>El eCTD es el formato actual y est\u00e1ndar de la FDA para presentar Aplicaciones de Nuevos Medicamentos (NDA), Aplicaciones de Nuevos Medicamentos en Investigaci\u00f3n (IND), Aplicaciones Abreviadas de Nuevos Medicamentos (ANDA) y ciertas Aplicaciones de Licencias para Biol\u00f3gicos (BLA). La FDA declara que las DMF suelen incluirse para estas aplicaciones y, por tanto, est\u00e1n sujetas a la presentaci\u00f3n electr\u00f3nica requerida por la secci\u00f3n 745A (a) de la Ley Federal de Alimentos, Medicamentos y Cosm\u00e9ticos (FD&amp;C).<\/p>\n<p>Despu\u00e9s de la fecha l\u00edmite, la FDA exigir\u00e1 a los usuarios que presenten sus DMF en la versi\u00f3n eCTD, admitida por el Cat\u00e1logo de Est\u00e1ndares de Datos de la FDA. Adem\u00e1s, un <a href=\"https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm333969.pdf\">documento orientativo de la FDA publicado en abril de 2017<\/a> establece especificaciones t\u00e9cnicas para aspectos tales como la estructura de presentaci\u00f3n, los formatos de archivo, las versiones de los componentes de presentaci\u00f3n y las ubicaciones requeridas para los conjuntos de datos y la informaci\u00f3n del estudio.<\/p>\n<p>Los DMF existentes que no est\u00e1n en formato eCTD, incluyendo los que est\u00e1n presentados en papel, no requerir\u00e1n una nueva presentaci\u00f3n; sin embargo, las presentaciones adicionales a estos DMF, tales como los informes anuales, suplementos y \u00a0enmiendas deben enviarse a trav\u00e9s de la ESG (Electronic Submissions Gateway) en formato eCTD. Las DMF existentes en formato papel que sean convertidas voluntariamente a eCTD conservar\u00e1n su n\u00famero actual de DMF. Las empresas suelen convertir sus DMF de papel a eCTD para agilizar el proceso de revisi\u00f3n de un NDA o ANDA que hace referencia a dicho DMF.<\/p>\n<p><strong>\u00bfC\u00f3mo Env\u00edo una Presentaci\u00f3n en eCTD?<\/strong><\/p>\n<p>Las presentaciones en eCTD que tengan 10 GB o menos se deben enviar a trav\u00e9s de la Electronic Communications Gateway (ESG) de la FDA. Antes de acceder a la ESG, un usuario debe solicitar un n\u00famero de presentaci\u00f3n de la FDA, crear una cuenta de ESG y configurar su computadora para comunicarse con la puerta de enlace. La FDA recomienda a los usuarios realizar una serie de pruebas antes de llevar a cabo la presentaci\u00f3n. El proceso para acceder a la ESG puede llevar varias semanas.<\/p>\n<p>Alternativamente, puede hacer el proceso m\u00e1s r\u00e1pido y f\u00e1cil contando con un Especialista Regulatorio, tal como Registrar Corp, para convertir sus presentaciones DMF de formato papel a eCTD y enviarlas a la FDA a trav\u00e9s de la ESG. Para obtener m\u00e1s informaci\u00f3n sobre los requisitos eCTD de la FDA para los DMF, contactarnos al: + 1-757-224-0177 o chatear con un asesor regulatorio las 24 horas del d\u00eda: <a href=\"https:\/\/regstaging.wpengine.com\/livehelp\">regstaging.wpengine.com\/livehelp<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A partir del 5 de Mayo de 2018, la Administraci\u00f3n de Alimentos y Medicamentos (FDA) de los Estados Unidos requerir\u00e1 el formato \u201celectronic common technical document\u201d (eCTD) para cualquier presentaci\u00f3n nueva de Drug Master File (DMF), incluyendo reportes y modificaciones. \u00bfQu\u00e9 es el eCTD? El eCTD es el formato actual y est\u00e1ndar de la FDA<\/p>\n","protected":false},"author":2,"featured_media":40108,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[60],"tags":[],"class_list":{"0":"post-40656","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-es","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A Partir del 5 de Mayo de 2018, los Establecimientos Farmac\u00e9uticos Deben Utilizar el Formato eCTD para Todas las Presentaciones de Drug Master Files (DMF) - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A Partir del 5 de Mayo de 2018, los Establecimientos Farmac\u00e9uticos Deben Utilizar el Formato eCTD para Todas las Presentaciones de Drug Master Files (DMF)\" \/>\n<meta property=\"og:description\" content=\"A partir del 5 de Mayo de 2018, la Administraci\u00f3n de Alimentos y Medicamentos (FDA) de los Estados Unidos requerir\u00e1 el formato \u201celectronic common technical document\u201d (eCTD) para cualquier presentaci\u00f3n nueva de Drug Master File (DMF), incluyendo reportes y modificaciones. \u00bfQu\u00e9 es el eCTD? 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