{"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":"mise-a-jour-de-larm-aux-etats-unis-et-dans-lue","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/us-eu-mra-update\/","title":{"rendered":"Mise \u00e0 jour : Accord de reconnaissance mutuelle entre les \u00c9tats-Unis et l&#039;UE"},"content":{"rendered":"<p>\u00c0 compter du 11 juillet 2019, la p\u00e9riode transitoire est termin\u00e9e et l&#039;application 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\">Accord de reconnaissance mutuelle<\/a>\u00a0(MRA) conclu entre les \u00c9tats-Unis et l&#039;Union europ\u00e9enne est en cours.<\/p>\n<h2 class=\"h4\">Le <strong>NOUS<\/strong> et <strong>UE<\/strong><\/h2>\n<p>Apr\u00e8s des ann\u00e9es d&#039;examen, la Food and Drug Administration (FDA) des \u00c9tats-Unis a v\u00e9rifi\u00e9 que chacun des 28 \u00c9tats membres de l&#039;UE avait la capacit\u00e9 de produire des m\u00e9dicaments \u00e0 usage humain dans des installations fonctionnant en conformit\u00e9 avec les normes\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\" target=\"_blank\" rel=\"noopener noreferrer\">Bonnes pratiques de fabrication (BPF)<\/a>De m\u00eame, la Commission europ\u00e9enne (CE) a confirm\u00e9 que la FDA dispose de proc\u00e9dures ad\u00e9quates pour effectuer des inspections BPF au m\u00eame niveau que l\u2019UE.<\/p>\n<h2 class=\"h4\">Qu&#039;est-ce que cela signifie <strong>Signifier<\/strong>?<\/h2>\n<p>En cons\u00e9quence, les \u00c9tats membres de l&#039;UE ne sont plus oblig\u00e9s de tester les lots de m\u00e9dicaments \u00e0 usage humain couverts par l&#039;ARM ; la FDA peut s&#039;appuyer sur les r\u00e9sultats des inspections de l&#039;UE, \u00e9liminant ainsi les mesures redondantes. L&#039;ARM offre \u00e0 la fois \u00e0 la FDA et \u00e0 l&#039;UE la capacit\u00e9 de concentrer leurs efforts d&#039;inspection sur les m\u00e9dicaments produits dans\u00a0<a href=\"https:\/\/www.oncozine.com\/united-states-and-europe-reach-milestone-agreement-on-mutual-recognition-of-inspections\/\" target=\"_blank\" rel=\"noopener noreferrer\">installations dans d&#039;autres pays<\/a>.<\/p>\n<p>La nouvelle directive porte principalement sur les m\u00e9dicaments \u00e0 usage humain, les produits biologiques et les m\u00e9dicaments v\u00e9t\u00e9rinaires, avec quelques exclusions. Les produits v\u00e9t\u00e9rinaires ne sont pas actuellement inclus, mais devraient \u00eatre pris en compte d&#039;ici le 15 d\u00e9cembre 2019. Les bonnes pratiques de fabrication (BPF) actuelles des installations de fabrication de vaccins et de produits d\u00e9riv\u00e9s du plasma ne sont pas non plus incluses, mais seront prises en compte d&#039;ici le 15 juillet 2022. Les produits suivants ne sont pas inclus et ne sont pas pris en compte :<\/p>\n<ul>\n<li>1. Sang humain<\/li>\n<li>2. Plasma humain<\/li>\n<li>3. Tissus et organes humains<\/li>\n<li>4. Immunologie v\u00e9t\u00e9rinaire<\/li>\n<\/ul>\n<p>Pour une liste compl\u00e8te des m\u00e9dicaments couverts par l&#039;ARM, cliquez ici\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\">ici<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Depuis le 11 juillet 2019, la p\u00e9riode de transition est termin\u00e9e et l&#039;application de l&#039;Accord de reconnaissance mutuelle (ARM) conclu entre les \u00c9tats-Unis et l&#039;Union europ\u00e9enne est en cours. Apr\u00e8s des ann\u00e9es d&#039;examen, la Food and Drug Administration (FDA) am\u00e9ricaine a v\u00e9rifi\u00e9 que chacun des 28 \u00c9tats membres de l&#039;UE a la capacit\u00e9\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 v27.3 (Yoast SEO v27.5) - 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\/fr\/mise-a-jour-de-larm-aux-etats-unis-et-dans-lue\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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\/fr\/mise-a-jour-de-larm-aux-etats-unis-et-dans-lue\/\" \/>\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 minutes\" \/>\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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