{"id":1147,"date":"2019-09-17T12:09:20","date_gmt":"2019-09-17T04:09:20","guid":{"rendered":"https:\/\/regask.com\/?p=1147"},"modified":"2024-11-16T05:12:39","modified_gmt":"2024-11-15T21:12:39","slug":"actualizacion-del-acuerdo-de-reconciliacion-militar-arm-entre-ee-uu-y-la-ue","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/us-eu-mra-update\/","title":{"rendered":"Actualizaci\u00f3n: Acuerdo de Reconocimiento Mutuo entre EE.UU. y\u2026"},"content":{"rendered":"<p>A partir del 11 de julio de 2019, finaliza el per\u00edodo transitorio y comienza la aplicaci\u00f3n de la\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/mutual-recognition-agreements-mra#united-states-section\" target=\"_blank\" rel=\"noopener noreferrer\">Acuerdo de reconocimiento mutuo<\/a>\u00a0El acuerdo de asociaci\u00f3n entre Estados Unidos y la Uni\u00f3n Europea est\u00e1 en marcha.<\/p>\n<h2 class=\"h4\">El <strong>A NOSOTROS<\/strong> y <strong>UE<\/strong><\/h2>\n<p>Tras a\u00f1os de an\u00e1lisis, la Administraci\u00f3n de Alimentos y Medicamentos de Estados Unidos (FDA) ha verificado que cada uno de los 28 estados miembros de la UE tiene la capacidad de producir medicamentos humanos en instalaciones que operan de conformidad con\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\" target=\"_blank\" rel=\"noopener noreferrer\">Buenas pr\u00e1cticas de fabricaci\u00f3n (BPF)<\/a>De manera similar, la Comisi\u00f3n Europea (CE) confirm\u00f3 que la FDA cuenta con procedimientos adecuados para realizar inspecciones de BPM al mismo nivel que la UE.<\/p>\n<h2 class=\"h4\">\u00bfQu\u00e9 significa esto? <strong>Significar<\/strong>?<\/h2>\n<p>Como resultado, los estados miembros de la UE ya no tienen la obligaci\u00f3n de realizar pruebas por lotes de medicamentos humanos cubiertos por el ARM; la FDA puede confiar en los resultados de las inspecciones de la UE, eliminando as\u00ed las medidas redundantes. El ARM ofrece tanto a la FDA como a la UE la capacidad de centrar los esfuerzos de inspecci\u00f3n en los medicamentos producidos en\u00a0<a href=\"https:\/\/www.oncozine.com\/united-states-and-europe-reach-milestone-agreement-on-mutual-recognition-of-inspections\/\" target=\"_blank\" rel=\"noopener noreferrer\">Instalaciones en otros pa\u00edses<\/a>.<\/p>\n<p>La nueva directriz cubre principalmente medicamentos para uso humano, productos biol\u00f3gicos y medicamentos veterinarios con algunas exclusiones. Los productos veterinarios no est\u00e1n incluidos actualmente, pero es probable que se consideren antes del 15 de diciembre de 2019. Las buenas pr\u00e1cticas de fabricaci\u00f3n actuales (CGMP) de las instalaciones que fabrican vacunas y productos derivados del plasma tampoco est\u00e1n incluidas, pero se considerar\u00e1n antes del 15 de julio de 2022. Los siguientes productos no est\u00e1n incluidos y no se est\u00e1n considerando:<\/p>\n<ul>\n<li>1. Sangre humana<\/li>\n<li>2. Plasma humano<\/li>\n<li>3. Tejidos y \u00f3rganos humanos<\/li>\n<li>4. Inmunol\u00f3gicos veterinarios<\/li>\n<\/ul>\n<p>Para obtener una lista completa de los medicamentos cubiertos por el MRA, haga clic en\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/mutual-recognition-agreements-mra#united-states-section\" target=\"_blank\" rel=\"noopener noreferrer\">aqu\u00ed<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>El 11 de julio de 2019, finaliz\u00f3 el per\u00edodo de transici\u00f3n y se puso en marcha la aplicaci\u00f3n del Acuerdo de Reconocimiento Mutuo (ARM) firmado entre Estados Unidos y la Uni\u00f3n Europea. Estados Unidos y la UE Despu\u00e9s de a\u00f1os de an\u00e1lisis, la Administraci\u00f3n de Alimentos y Medicamentos de Estados Unidos (FDA) ha verificado que cada uno de los 28 estados miembros de la UE tiene la capacidad\u2026<\/p>","protected":false},"author":39,"featured_media":2207,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,30],"tags":[],"class_list":["post-1147","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-and-biotech-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US-EU Mutual Recognition Agreement | RegASK<\/title>\n<meta name=\"description\" content=\"Stay informed on the latest updates to the Mutual Recognition Agreement (MRA) between the US and EU with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/actualizacion-del-acuerdo-de-reconciliacion-militar-arm-entre-ee-uu-y-la-ue\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Update: Mutual Recognition Agreement between the U.S. and EU\" \/>\n<meta property=\"og:description\" content=\"Stay informed on the latest updates to the Mutual Recognition Agreement (MRA) between the US and EU with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/actualizacion-del-acuerdo-de-reconciliacion-militar-arm-entre-ee-uu-y-la-ue\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2019-09-17T04:09:20+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-15T21:12:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2020\/11\/Update-Mutual-Recognition-Agreement-between-the-U.S.-and-EU.png\" \/>\n\t<meta property=\"og:image:width\" content=\"600\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/us-eu-mra-update\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-eu-mra-update\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Update: Mutual Recognition Agreement between the U.S. a&hellip;\",\"datePublished\":\"2019-09-17T04:09:20+00:00\",\"dateModified\":\"2024-11-15T21:12:39+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-eu-mra-update\\\/\"},\"wordCount\":251,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-eu-mra-update\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2020\\\/11\\\/Update-Mutual-Recognition-Agreement-between-the-U.S.-and-EU.png\",\"articleSection\":[\"United States\",\"Pharma &amp; 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