{"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":"us-eu-mra-update","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/us-eu-mra-update\/","title":{"rendered":"Update: Abkommen zur gegenseitigen Anerkennung zwischen den USA und\u2026"},"content":{"rendered":"<p>Am 11. Juli 2019 endete die \u00dcbergangsfrist, und die Durchsetzung der\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\">Abkommen \u00fcber gegenseitige Anerkennung<\/a>\u00a0Das zwischen den Vereinigten Staaten und der Europ\u00e4ischen Union geschlossene Abkommen (MRA) ist im Gange.<\/p>\n<h2 class=\"h4\">Der <strong>UNS<\/strong> Und <strong>EU<\/strong><\/h2>\n<p>Nach jahrelanger Pr\u00fcfung hat die US-amerikanische Food and Drug Administration (FDA) best\u00e4tigt, dass alle 28 EU-Mitgliedsstaaten in der Lage sind, Humanarzneimittel in Einrichtungen herzustellen, die den\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\" target=\"_blank\" rel=\"noopener noreferrer\">Gute Herstellungspraxis (GMP)<\/a>Ebenso best\u00e4tigte die Europ\u00e4ische Kommission (EK), dass die FDA \u00fcber angemessene Verfahren verf\u00fcgt, um GMP-Inspektionen auf demselben Niveau wie die EU durchzuf\u00fchren.<\/p>\n<h2 class=\"h4\">Was bedeutet das <strong>Bedeuten<\/strong>?<\/h2>\n<p>Die EU-Mitgliedstaaten sind daher nicht mehr verpflichtet, Chargenpr\u00fcfungen f\u00fcr Humanarzneimittel durchzuf\u00fchren, die unter das MRA fallen. Die FDA kann sich auf die Ergebnisse der EU-Inspektionen st\u00fctzen und so redundante Ma\u00dfnahmen vermeiden. Das MRA erm\u00f6glicht es sowohl der FDA als auch der EU, ihre Inspektionsbem\u00fchungen auf Arzneimittel zu konzentrieren, die in\u00a0<a href=\"https:\/\/www.oncozine.com\/united-states-and-europe-reach-milestone-agreement-on-mutual-recognition-of-inspections\/\" target=\"_blank\" rel=\"noopener noreferrer\">Einrichtungen in anderen L\u00e4ndern<\/a>.<\/p>\n<p>Die neue Richtlinie umfasst vor allem Humanarzneimittel, Biologika und Tierarzneimittel, mit einigen Ausnahmen. Tierarzneimittel sind derzeit nicht enthalten, werden aber voraussichtlich bis zum 15. Dezember 2019 ber\u00fccksichtigt. Die aktuellen guten Herstellungspraktiken (CGMPs) von Einrichtungen, die Impfstoffe und Plasmaprodukte herstellen, sind ebenfalls nicht enthalten, werden aber bis zum 15. Juli 2022 ber\u00fccksichtigt. Die folgenden Produkte sind nicht enthalten und werden nicht ber\u00fccksichtigt:<\/p>\n<ul>\n<li>1. Menschliches Blut<\/li>\n<li>2. Menschliches Plasma<\/li>\n<li>3. Menschliche Gewebe und Organe<\/li>\n<li>4. Veterin\u00e4rimmunologika<\/li>\n<\/ul>\n<p>Eine vollst\u00e4ndige Liste der unter das MRA fallenden Arzneimittel finden Sie hier:\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\">Hier<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>As of July 11, 2019, the transitionary period is over, and enforcement of the\u00a0Mutual Recognition Agreement\u00a0(MRA) struck between the United States and the European Union is underway. The US and EU After years of examination, the US Food and Drug Administration (FDA) has verified that each of the EU\u2019s 28 member states has the ability&#8230;<\/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 v28.3 (Yoast SEO v28.3) - 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\/de\/us-eu-mra-update\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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\/de\/us-eu-mra-update\/\" \/>\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\u00a0Minuten\" \/>\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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