{"id":18485,"date":"2023-01-16T08:19:11","date_gmt":"2023-01-16T07:19:11","guid":{"rendered":"https:\/\/www.m-q.ch\/?p=17419"},"modified":"2024-11-19T10:27:32","modified_gmt":"2024-11-19T09:27:32","slug":"arzneimittel-schweiz-und-usa-unterzeichnen-mra","status":"publish","type":"post","link":"https:\/\/www.organisator.ch\/it\/operational-excellence\/2023-01-16\/arzneimittel-schweiz-und-usa-unterzeichnen-mra\/","title":{"rendered":"Prodotti farmaceutici: Svizzera e Stati Uniti firmano un ARR"},"content":{"rendered":"<figure id=\"attachment_17420\" class=\"wp-caption alignnone\" style=\"width: 680px\" aria-describedby=\"caption-attachment-17420\"><img class=\"alignnone wp-image-17420 size-full\" src=\"https:\/\/www.m-q.ch\/wp-content\/uploads\/2023\/01\/Arzneimittel-Schweiz-und-USA-unterzeichnen-MRA_MQ.jpg\" alt=\"Prodotti farmaceutici MRA GMP\" width=\"680\" height=\"383\" \/>\r\n<figcaption id=\"caption-attachment-17420\" class=\"wp-caption-text\">Dopo la firma dell'MRA GMP per i medicinali: da sinistra a destra: Andi Fristedt (FDA Deputy Commissioner for Policy, Legislation, and International Affairs), Jayme White (Deputy United States Trade Representative), Helene Budliger Artieda (Direttrice della Segreteria di Stato per gli Affari Economici SECO), Dr J\u00f6rg Schl\u00e4pfer (Swissmedic, Head of Staff and International Affairs). (Fonte: Ambasciata svizzera a Washington DC \/ www.economiesuisse.ch)<\/figcaption>\r\n<\/figure>\r\n<p>Con un volume di scambi commerciali di 900 miliardi di franchi, gli Stati Uniti sono oggi il pi\u00f9 importante partner commerciale della Svizzera. Gli Stati Uniti sono anche un importante mercato di esportazione per l'industria farmaceutica svizzera: il 26% delle esportazioni di farmaci attraversa l'Atlantico. Finora, tuttavia, il commercio \u00e8 stato associato a una serie di ostacoli amministrativi. Ad esempio, i farmaci devono essere prodotti secondo le norme di buona fabbricazione (GMP) concordate a livello internazionale. La conformit\u00e0 a queste regole viene controllata due volte: in Svizzera da Swissmedic e negli Stati Uniti dalla Food and Drug Administration FDA.\u00a0<\/p>\r\n<h3>Riduzione degli ostacoli per l'approvazione dei farmaci<\/h3>\r\n<p>L'accordo firmato il 12 gennaio 2023 garantisce ora il riconoscimento reciproco (Mutual Recognition Agreement MRA) delle GMP. Ci\u00f2 significa che Swissmedic e la FDA si asterranno dall'ispezionare i siti di produzione dei produttori di medicinali dell'altro Paese dopo un'approfondita revisione delle pratiche ispettive del Paese partner. Si tratta di una situazione vantaggiosa per entrambe le parti, poich\u00e9 tali ispezioni impegnano risorse e costano tempo e denaro - \"rapidamente pi\u00f9 di un milione di franchi\", secondo l'associazione industriale Interpharma. Questi fondi possono ora essere investiti nell'innovazione grazie alla cancellazione delle ispezioni reciproche.\u00a0<\/p>\r\n<p>L'accordo elimina una cosiddetta barriera commerciale non tariffaria. Secondo il Dipartimento federale dell'economia, della formazione e della ricerca (DEFR), l'ARR GMP contribuisce anche alla diversificazione delle relazioni commerciali, comprese le catene di produzione e di approvvigionamento transfrontaliere della Svizzera. In questo modo, l'ARR sostiene la sicurezza dell'approvvigionamento e la resilienza dell'economia svizzera, che dipende dal commercio estero, in particolare alla luce delle distorsioni globali in corso per quanto riguarda il commercio internazionale, secondo la dichiarazione pubblicata sull'argomento.<\/p>\r\n<h3>La mozione chiede un'ARR simile per i dispositivi medici<\/h3>\r\n<p>Esistono gi\u00e0 ARR GMP comparabili tra gli Stati Uniti e l'UE e il Regno Unito. La Svizzera, da parte sua, ha gi\u00e0 concluso MRA GMP con l'UE, il Regno Unito e la Corea del Sud. L'accordo mira a creare condizioni di parit\u00e0 per la Svizzera come centro farmaceutico per il mercato statunitense rispetto all'UE e al Regno Unito. Tuttavia, i dispositivi medici che non rientrano nel settore farmaceutico sono ancora esclusi. Una mozione del Consigliere nazionale Damian M\u00fcller vuole cambiare questa situazione e chiede un MRA con gli Stati Uniti e altri Paesi per l'autorizzazione dei dispositivi medici (ad esempio, pompe per insulina, maschere protettive mediche, protesi, ecc.) Dopo l'entrata in vigore del nuovo Regolamento sui dispositivi medici dell'UE nel 2021, la Svizzera sar\u00e0 considerata un \"Paese terzo\" perch\u00e9 non esiste un accordo quadro tra la Svizzera e l'UE. Ci\u00f2 comporta un elevato ostacolo amministrativo per l'autorizzazione dei dispositivi medici e potrebbe significare che alcuni prodotti non saranno pi\u00f9 disponibili in Svizzera nel medio-lungo termine.<\/p>\r\n<p><em>Fonti: <a href=\"http:\/\/www.economiesuisse.ch\/\">economiesuisse<\/a>, <a href=\"https:\/\/www.admin.ch\/gov\/de\/start\/dokumentation\/medienmitteilungen.msg-id-92267.html\">WBF\/Swissmedic<\/a>, <a href=\"http:\/\/www.interpharma.ch\/\">interfarma<\/a><\/em><\/p>\n<p class=\"syndicated-attribution\">Questo articolo \u00e8 apparso originariamente su m-q.ch - <a href=\"https:\/\/www.m-q.ch\/de\/arzneimittel-schweiz-und-usa-unterzeichnen-mra\/\" target=\"_blank\">https:\/\/www.m-q.ch\/de\/arzneimittel-schweiz-und-usa-unterzeichnen-mra\/<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Die USA sind inzwischen mit einem Handelsvolumen von 900 Milliarden Franken der wichtigste Handelspartner der Schweiz. Auch f\u00fcr die Schweizer Pharmaindustrie sind die Vereinigten Staaten ein grosser Exportmarkt: 26 Prozent der Ausfuhren von Medikamenten gehen mittlerweile \u00fcber den Atlantik. Bisher war der Handel aber mit etlichen administrativen H\u00fcrden verbunden. So m\u00fcssen Arzneimittel nach international vereinbarten [\u2026]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_yoast_wpseo_focuskw":"MRA GMP Arzneimittel","_yoast_wpseo_metadesc":"MRA GMP-Abkommen: Schweiz und USA vereinbaren gegenseitige Anerkennung. Erleichterte Arzneimittel-Zulassung und Ressourceneinsparung.","articlekey":"","footnotes":""},"categories":[582],"tags":[],"class_list":["post-18485","post","type-post","status-publish","format-standard","hentry","category-operational-excellence"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Arzneimittel: Schweiz und USA unterzeichnen MRA - Organisator<\/title>\n<meta name=\"description\" content=\"MRA GMP-Abkommen: Schweiz und USA vereinbaren gegenseitige Anerkennung. 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