{"id":51530,"date":"2021-08-05T10:13:22","date_gmt":"2021-08-05T14:13:22","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022\/"},"modified":"2021-08-19T09:50:19","modified_gmt":"2021-08-19T13:50:19","slug":"fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022\/","title":{"rendered":"A FDA anuncia novas taxas de usu\u00e1rios para Dispositivos M\u00e9dicos e Medicamentos Gen\u00e9ricos para o ano fiscal de 2022"},"content":{"rendered":"<p>A Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) anunciou novas taxas para o ano fiscal (FY) 2022 sob a altera\u00e7\u00e3o das taxas de usu\u00e1rios para medicamentos gen\u00e9ricos (GDUFA) e a altera\u00e7\u00e3o da taxa de usu\u00e1rio para dispositivos m\u00e9dicos (MDFA).<\/p>\n<p>O ano fiscal come\u00e7a em 1\u00ba de outubro de 2021 e termina em 30 de setembro de 2022. Os estabelecimentos de medicamentos e dispositivos m\u00e9dicos devem pagar as taxas para manter seu status de acordo com a FDA.<\/p>\n<p><strong>Taxas para Estabelecimentos de Medicamentos<\/strong><\/p>\n<p>Sob a Lei GDUFA, a FDA avalia e coleta as taxas de estabelecimentos de ingredientes farmac\u00eauticos ativos (API), estabelecimentos de f\u00f3rmulas de dosagem finais (FDF) e organiza\u00e7\u00e3o contratada para fabrica\u00e7\u00e3o (CMO). As taxas dos estabelecimentos fora dos Estados Unidos s\u00e3o maiores para compensar o custo adicional de uma inspe\u00e7\u00e3o.<\/p>\n<p>As taxas GDUFA de estabelecimento aumentaram para o ano fiscal 2022, revertendo a redu\u00e7\u00e3o da taxa de 2020 a 2021. As taxas de API nacionais e estrangeiras aumentaram em aproximadamente 2%. As taxas de FDF e CMO aumentaram tanto para empresas dos EUA. Quanto \u00e0s empresas estrangeiras em aproximadamente 5%. Pelo contr\u00e1rio, as empresas de todos os tamanhos viram aproximadamente uma redu\u00e7\u00e3o de 0,4% nas taxas de programas.<\/p>\n<p>O aumento das taxas dos estabelecimentos poder\u00e1 ter um ajuste do ano passado, o que permite ao FDA aumentar as taxas para fornecer at\u00e9 3 meses de reservas operacionais. As reservas compensar\u00e3o os custos associados \u00e0s atividades de medicamentos gen\u00e9ricos humanos projetadas para o in\u00edcio do ano fiscal 2023. Para determinar o ajuste, a FDA analisou a coleta e obriga\u00e7\u00f5es projetadas considerando que o encargo financeiro aumentou as taxas no setor. Em \u00faltima an\u00e1lise, a FDA decidiu aumentar as taxas para fornecer 7 semanas de reservas operacionais.<\/p>\n<p><strong>Taxas de GDUFA Para Ano Fiscal<\/strong><\/p>\n<table class=\"feeTable statistics\" style=\"border: 1px solid grey; border-spacing: 0px !important;\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"313\"><strong>Tipo de Taxa<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"168\"><strong>FY 2021<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"157\"><strong>FY 2022<\/strong><\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"313\"><strong>Taxas de Estabelecimentos<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"90\"><strong>Dom\u00e9stico<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"78\"><strong>Estrangeiro<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"78\"><strong>Dom\u00e9stico<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"79\"><strong>Estrangeiro<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Ingrediente Farmac\u00eauticos Ativos (API)<\/td>\n<td width=\"90\">U$ 41,671<\/td>\n<td width=\"78\">U$ 56,671<\/td>\n<td width=\"78\">U$ 42,557<\/td>\n<td width=\"79\">U$ 57,557<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Forma de Dosagem finais (FDF)<\/td>\n<td width=\"90\">U$ 184,022<\/td>\n<td width=\"78\">U$ 199,022<\/td>\n<td width=\"78\">U$ 195,012<\/td>\n<td width=\"79\">U$ 210,012<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Organiza\u00e7\u00e3o de Fabricantes por Contrato (CMO)<\/td>\n<td width=\"90\">U$ 61,341<\/td>\n<td width=\"78\">U$ 76,341<\/td>\n<td width=\"78\">U$ 65,004<\/td>\n<td width=\"79\">U$ 80,004<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"5\" width=\"638\"><strong>Taxas do Programa GDUFA: Com Base no N\u00famero de ANDAs aprovadas<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Grande (20 ou mais ANDAs)<\/td>\n<td colspan=\"2\" width=\"168\">U$ 1,542,993<\/td>\n<td colspan=\"2\" width=\"157\">U$ 1,536,856<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">M\u00e9dio (6 a 19 ANDAs)<\/td>\n<td colspan=\"2\" width=\"168\">U$ 617,197<\/td>\n<td colspan=\"2\" width=\"157\">U$ 614,742<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Pequeno (5 ou menos ANDAs)<\/td>\n<td colspan=\"2\" width=\"168\">U$ 154,299<\/td>\n<td colspan=\"2\" width=\"157\">U$ 153,686<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"5\" width=\"638\"><strong>Custos de Aplica\u00e7\u00e3o<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">ANDA<\/td>\n<td colspan=\"2\" width=\"168\">U$ 196,868<\/td>\n<td colspan=\"2\" width=\"157\">U$ 225,712<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">DMF Tipo II<\/td>\n<td colspan=\"2\" width=\"168\">U$ 69,921<\/td>\n<td colspan=\"2\" width=\"157\">U$ 74,952<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Taxas para Dispositivos M\u00e9dicos<\/strong><\/p>\n<p>A FDA requer o pagamento de taxas para determinadas aplica\u00e7\u00f5es de dispositivos m\u00e9dicos, relat\u00f3rios peri\u00f3dicos sobre dispositivos Classe III e para o registro anual de estabelecimentos. As empresas com vendas totais de menos de US $ 100 milh\u00f5es para o ano fiscal mais recente podem se qualificar como uma pequena empresa para acessar uma taxa reduzida nessas aplica\u00e7\u00f5es. As empresas com vendas totais com menos de US $ 30 milh\u00f5es podem receber uma isen\u00e7\u00e3o dos primeiros aplica\u00e7\u00f5es ou apresenta\u00e7\u00f5es 510k &#8220;Pr\u00e9 mercado&#8221;. Se voc\u00ea qualifica para uma taxa reduzida para o ano fiscal 2021, voc\u00ea deve enviar suas informa\u00e7\u00f5es novamente durante a renova\u00e7\u00e3o para a FDA a fim de manter a classifica\u00e7\u00e3o.<\/p>\n<p>Pequenas empresas n\u00e3o recebem uma redu\u00e7\u00e3o nas taxas de registros de estabelecimento. Os requisitos de registro de um estabelecimento s\u00e3o os mesmos para empresas de todos os tamanhos e a FDA n\u00e3o considera um registro a ser conclu\u00eddo at\u00e9, efetivamente, receber o pagamento. Al\u00e9m disso, esta taxa \u00e9 aplicada para cada um dos estabelecimentos que possui uma empresa e que possui certas fun\u00e7\u00f5es em dispositivos m\u00e9dicos. No ano 2022, as taxas de dispositivos m\u00e9dicos aumentaram aproximadamente 2,5% em compara\u00e7\u00e3o ao ano fiscal de 2021. A FDA explica que isso \u00e9 para cobrir o custo da infla\u00e7\u00e3o do ano passado.<\/p>\n<p><strong>Taxas MDUFA para o Ano Fiscal 2022<\/strong><\/p>\n<table class=\"feeTable statistics\" style=\"border: 1px solid grey; border-spacing: 0px !important;\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"229\"><strong>Tipo de Taxa<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"196\"><strong>2021<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" colspan=\"2\" width=\"213\"><strong>2022<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Registro Anual de Estabelecimento<\/td>\n<td colspan=\"2\" width=\"196\">U$ 5,546<\/td>\n<td colspan=\"2\" width=\"213\">U$ 5,672<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"229\"><strong>Custos de Aplica\u00e7\u00e3o<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"90\"><strong>Padr\u00e3o<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Pequenos Neg\u00f3cios<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Padr\u00e3o<\/strong><\/td>\n<td class=\"dark-bg\" style=\"background: #ddd;\" width=\"106\"><strong>Pequenos Neg\u00f3cios<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">510(k)<\/td>\n<td width=\"90\">U$ 12,432<\/td>\n<td width=\"106\">U$ 3,108<\/td>\n<td width=\"106\">U$ 12,745<\/td>\n<td width=\"106\">U$ 3,186<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">513(g)<\/td>\n<td width=\"90\">U$ 4,936<\/td>\n<td width=\"106\">U$ 2,468<\/td>\n<td width=\"106\">U$ 5,061<\/td>\n<td width=\"106\">U$ 2,530<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Classifica\u00e7\u00e3o De Novo<\/td>\n<td width=\"90\">U$ 109,697<\/td>\n<td width=\"106\">U$ 27,424<\/td>\n<td width=\"106\">U$ 112,457<\/td>\n<td width=\"106\">U$ 28,114<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">PMA, PDP, PMR, BLA<\/td>\n<td width=\"90\">U$ 365,657<\/td>\n<td width=\"106\">U$ 91,414<\/td>\n<td width=\"106\">U$ 374,858<\/td>\n<td width=\"106\">U$ 93,714<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplementos Painel-track<\/td>\n<td width=\"90\">U$ 274,243<\/td>\n<td width=\"106\">U$ 68,561<\/td>\n<td width=\"106\">U$ 281,143<\/td>\n<td width=\"106\">U$ 70,286<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplementos 180-dias<\/td>\n<td width=\"90\">U$ 54,849<\/td>\n<td width=\"106\">U$ 13,712<\/td>\n<td width=\"106\">U$ 56,229<\/td>\n<td width=\"106\">U$ 14,057<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplementos em Tempo Real<\/td>\n<td width=\"90\">U$ 25,596<\/td>\n<td width=\"106\">U$ 6,399<\/td>\n<td width=\"106\">U$ 26,240<\/td>\n<td width=\"106\">U$ 6,560<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Suplementos de Efic\u00e1cia BLA<\/td>\n<td width=\"90\">U$ 365,657<\/td>\n<td width=\"106\">U$ 91,414<\/td>\n<td width=\"106\">U$ 374,858<\/td>\n<td width=\"106\">U$ 93,714<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Reporte Anual PMA<\/td>\n<td width=\"90\">U$ 12,798<\/td>\n<td width=\"106\">U$ 3,200<\/td>\n<td width=\"106\">U$ 13,120<\/td>\n<td width=\"106\">U$ 3,280<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>A Registrar Corp \u00e9 uma empresa privada que auxilia as empresas em conformidade com os regulamentos com a FDA. Podemos ajud\u00e1-lo a determinar quais taxas se aplicam ao seu estabelecimento e facilitar o pagamento do FDA. Para mais informa\u00e7\u00f5es, ligue para + 1-757-224-0177, envie um e-mail para: <a href=\"mailto:info@registracorp.com\">info@registracorp.com<\/a> ou converse no chat com um consultor regulamentar 24 horas por dia em <a href=\"https:\/\/www.registricorcorp.com\/livechat\">www.registricorcorp.com\/livechat<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) anunciou novas taxas para o ano fiscal (FY) 2022 sob a altera\u00e7\u00e3o das taxas de usu\u00e1rios para medicamentos gen\u00e9ricos (GDUFA) e a altera\u00e7\u00e3o da taxa de usu\u00e1rio para dispositivos m\u00e9dicos (MDFA). O ano fiscal come\u00e7a em 1\u00ba de outubro de 2021 e termina em 30<\/p>\n","protected":false},"author":30,"featured_media":39535,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[99,96],"tags":[],"class_list":{"0":"post-51530","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-devices-pt","8":"category-drugs-pt","9":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A FDA anuncia novas taxas de usu\u00e1rios para Dispositivos M\u00e9dicos e Medicamentos Gen\u00e9ricos para o ano fiscal de 2022 - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A FDA anuncia novas taxas de usu\u00e1rios para Dispositivos M\u00e9dicos e Medicamentos Gen\u00e9ricos para o ano fiscal de 2022\" \/>\n<meta property=\"og:description\" content=\"A Administra\u00e7\u00e3o de Alimentos e Medicamentos dos Estados Unidos (FDA) anunciou novas taxas para o ano fiscal (FY) 2022 sob a altera\u00e7\u00e3o das taxas de usu\u00e1rios para medicamentos gen\u00e9ricos (GDUFA) e a altera\u00e7\u00e3o da taxa de usu\u00e1rio para dispositivos m\u00e9dicos (MDFA). 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