{"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\/fr\/operational-excellence\/2023-01-16\/arzneimittel-schweiz-und-usa-unterzeichnen-mra\/","title":{"rendered":"M\u00e9dicaments : la Suisse et les Etats-Unis signent un ARM"},"content":{"rendered":"
\"MRA\r\n
Apr\u00e8s la signature du MRA GMP pour les m\u00e9dicaments : de gauche \u00e0 droite : Andi Fristedt (FDA Deputy Commissioner for Policy, Legislation, and International Affairs), Jayme White (Deputy United States Trade Representative), Helene Budliger Artieda (Directrice du Secr\u00e9tariat d'Etat \u00e0 l'\u00e9conomie SECO), Dr. J\u00f6rg Schl\u00e4pfer (Swissmedic, Chef du secteur Etat-major et Affaires internationales). (Source : Ambassade de Suisse \u00e0 Washington DC \/ www.economiesuisse.ch)<\/figcaption>\r\n<\/figure>\r\n

Avec un volume commercial de 900 milliards de francs, les Etats-Unis sont d\u00e9sormais le principal partenaire commercial de la Suisse. Pour l'industrie pharmaceutique suisse \u00e9galement, les Etats-Unis sont un grand march\u00e9 d'exportation : 26 pour cent des exportations de m\u00e9dicaments traversent d\u00e9sormais l'Atlantique. Jusqu'\u00e0 pr\u00e9sent, le commerce \u00e9tait toutefois li\u00e9 \u00e0 de nombreux obstacles administratifs. Ainsi, les m\u00e9dicaments doivent \u00eatre produits selon les r\u00e8gles de bonnes pratiques de fabrication (Good Manufacturing Practices GMP) convenues au niveau international. Le respect de ces r\u00e8gles est doublement contr\u00f4l\u00e9 : en Suisse par Swissmedic et aux Etats-Unis par la Food and Drug Administration FDA.\u00a0<\/p>\r\n

Des obstacles plus bas pour l'autorisation des m\u00e9dicaments<\/h3>\r\n

L'accord sign\u00e9 le 12 janvier 2023 assure d\u00e9sormais la reconnaissance mutuelle (Mutual Recognition Agreement MRA) des BPF. Cela signifie que Swissmedic et la FDA renoncent \u00e0 inspecter les sites de production des fabricants de m\u00e9dicaments dans l'autre pays apr\u00e8s un examen approfondi des pratiques d'inspection de l'\u00c9tat partenaire. C'est un gain pour les deux parties : en effet, de telles inspections mobilisent des ressources et co\u00fbtent du temps et de l'argent - \"rapidement plus d'un million de francs\" selon l'association professionnelle Interpharma. Ces moyens peuvent d\u00e9sormais \u00eatre investis dans l'innovation apr\u00e8s la suppression des inspections r\u00e9ciproques.\u00a0<\/p>\r\n

L'accord supprime ce que l'on appelle un obstacle non tarifaire au commerce. Selon le communiqu\u00e9 du D\u00e9partement f\u00e9d\u00e9ral de l'\u00e9conomie, de la formation et de la recherche (DEFR), l'ARM GMP contribue en outre \u00e0 la diversification des relations commerciales, y compris des cha\u00eenes de production et d'approvisionnement transfrontali\u00e8res de la Suisse. L'ARM contribue ainsi \u00e0 la s\u00e9curit\u00e9 de l'approvisionnement et \u00e0 la r\u00e9silience de l'\u00e9conomie suisse, qui d\u00e9pend du commerce ext\u00e9rieur, notamment au vu des perturbations persistantes du commerce international, selon le communiqu\u00e9 publi\u00e9 \u00e0 ce sujet.<\/p>\r\n

Une motion demande un ARM similaire pour les dispositifs m\u00e9dicaux<\/h3>\r\n

Des GMP MRA comparables existent d\u00e9j\u00e0 entre les Etats-Unis et l'UE ainsi que le Royaume-Uni. De son c\u00f4t\u00e9, la Suisse a d\u00e9j\u00e0 conclu des GMP MRA avec l'UE, le Royaume-Uni, ainsi qu'avec la Cor\u00e9e du Sud. L'accord doit cr\u00e9er des conditions \u00e9gales pour le site pharmaceutique suisse par rapport \u00e0 l'UE et au Royaume-Uni sur le march\u00e9 am\u00e9ricain. Les produits m\u00e9dicaux qui ne rel\u00e8vent pas du domaine pharmaceutique restent toutefois en dehors de l'accord. Une motion du conseiller national Damian M\u00fcller veut changer cela et demande un ARM avec les \u00c9tats-Unis et d'autres pays pour l'autorisation des dispositifs m\u00e9dicaux (p. ex. pompes \u00e0 insuline, masques de protection m\u00e9dicaux, proth\u00e8ses, etc.) En effet, apr\u00e8s l'entr\u00e9e en vigueur du nouveau r\u00e8glement de l'UE sur les dispositifs m\u00e9dicaux en 2021, la Suisse y sera consid\u00e9r\u00e9e comme un \"pays tiers\" en raison de l'absence d'un accord-cadre entre la Suisse et l'UE. Pour l'autorisation des dispositifs m\u00e9dicaux, cela repr\u00e9sente un obstacle administratif important et peut conduire, \u00e0 moyen ou long terme, \u00e0 ce que certains produits ne soient plus disponibles en Suisse.<\/p>\r\n

Sources : economiesuisse<\/a>, WBF\/Swissmedic<\/a>, interpharma<\/a><\/em><\/p>\n

Cet article est paru initialement sur m-q.ch - https:\/\/www.m-q.ch\/de\/arzneimittel-schweiz-und-usa-unterzeichnen-mra\/<\/a><\/p>","protected":false},"excerpt":{"rendered":"

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":"\nArzneimittel: 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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