{"id":54712,"date":"2022-01-19T09:23:43","date_gmt":"2022-01-19T14:23:43","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/drug-industry-raises-concerns-over-cares-act-reporting-deadline\/"},"modified":"2022-02-11T14:53:15","modified_gmt":"2022-02-11T19:53:15","slug":"drug-industry-raises-concerns-over-cares-act-reporting-deadline","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/drug-industry-raises-concerns-over-cares-act-reporting-deadline\/","title":{"rendered":"Ind\u00fastria Farmac\u00eautica Expressa Preocupa\u00e7\u00e3o com o Prazo para Relat\u00f3rios da Lei CARES"},"content":{"rendered":"

A ind\u00fastria farmac\u00eautica est\u00e1 levantando preocupa\u00e7\u00f5es sobre o momento dos novos requisitos de Notifica\u00e7\u00e3o de Medicamentos da Administra\u00e7\u00e3o de Alimentos e Medicamentos (FDA) dos EUA. Os requisitos, criados como parte da Lei de Aux\u00edlio, Al\u00edvio e Seguran\u00e7a Econ\u00f4mica de Coronav\u00edrus (Lei CARES), exigem que os estabelecimentos de medicamentos registrados pela FDA enviem relat\u00f3rios anuais \u00e0 FDA sobre a quantidade de cada medicamento listado que a empresa fabricou. compostos ou processados para distribui\u00e7\u00e3o comercial. A FDA quer que as empresas enviem os relat\u00f3rios do ano civil (CY) 2020 at\u00e9 15 de fevereiro de 2022 e os relat\u00f3rios do ano civil 2021 at\u00e9 16 de maio de 2022.<\/p>\n

As empresas farmac\u00eauticas enviaram coment\u00e1rios p\u00fablicos em resposta \u00e0 Guia da FDA detalhando esses requisitos. Muitas empresas est\u00e3o preocupadas com o fato de n\u00e3o conseguirem coletar as informa\u00e7\u00f5es necess\u00e1rias antes do prazo de 15 de fevereiro. Esses estabelecimentos est\u00e3o solicitando ao FDA a prorroga\u00e7\u00e3o do prazo, permitindo \u00e0s empresas mais tempo para resolver os desafios log\u00edsticos de coleta e prepara\u00e7\u00e3o das informa\u00e7\u00f5es necess\u00e1rias.<\/p>\n

\n

N\u00e3o tem tempo ou recursos para cumprir os requisitos de Relat\u00f3rios da Lei CARES? A Registrar Corp pode ajud\u00e1-lo a enviar seus relat\u00f3rios.<\/h3>\n

A Registrar Corp pode ajudar as empresas farmac\u00eauticas a enviar relat\u00f3rios adequadamente para atender aos requisitos da Lei CARES. Para obter mais informa\u00e7\u00f5es, ligue para +1-757-224-0177, envie um e-mail para info@registrarcorp.com<\/a> ou converse com um consultor regulat\u00f3rio 24 horas por dia em regstaging.wpengine.com\/livechat<\/a>.<\/p>\n

Obtenha Assist\u00eancia<\/a><\/p>\n<\/div>\n

Quais s\u00e3o os pensamentos da ind\u00fastria farmac\u00eautica sobre os requisitos de relat\u00f3rios de medicamentos da FDA? Continue lendo o artigo para obter os detalhes.<\/p>\n

N\u00f3s N\u00e3o Temos Tempo Suficiente<\/strong><\/p>\n

Em seus coment\u00e1rios, a empresa de medicamentos gen\u00e9ricos Viatris observou a natureza complexa das informa\u00e7\u00f5es a serem inclu\u00eddas nos relat\u00f3rios da Lei CARES. Como todos os relat\u00f3rios devem corresponder a um n\u00famero do C\u00f3digo Nacional de Medicamentos (NDC), grandes empresas com estoque extenso contendo v\u00e1rios n\u00fameros de NDC por produto precisar\u00e3o enviar um n\u00famero significativo de relat\u00f3rios.<\/p>\n

A Viatris afirmou que, para fornecer as informa\u00e7\u00f5es solicitadas, a ind\u00fastria precisaria “compilar, formatar e enviar mais de 3,3 milh\u00f5es de pontos de dados \u00e0 Ag\u00eancia em menos de quatro meses ap\u00f3s a emiss\u00e3o do projeto de orienta\u00e7\u00e3o”.<\/p>\n

Juntamente com outras empresas, a Viatris est\u00e1 pedindo ao FDA que considere estender o prazo de 15 de fevereiro. Embora as instala\u00e7\u00f5es tenham sugerido datas variadas, a maioria prop\u00f4s mudar o prazo de envio dos relat\u00f3rios do ano fiscal de 2020 para abril de 2022 ou posterior.<\/p>\n

Pessoal Insuficiente<\/strong><\/p>\n

As partes que comentaram, tamb\u00e9m explicaram que sua equipe atual n\u00e3o pode acomodar de maneira vi\u00e1vel a carga de trabalho adicional necess\u00e1ria para apresentar relat\u00f3rios detalhados da Lei CARES. Como as empresas ainda n\u00e3o tinham as pessoas e os processos para atender a esse requisito, \u00e9 prov\u00e1vel que muitas n\u00e3o tenham atualmente a equipe para se dedicar a relat\u00f3rios complexos. Alguns estabelecimentos precisar\u00e3o coletar esses dados de v\u00e1rias instala\u00e7\u00f5es espalhadas pelo mundo.<\/p>\n

A Associa\u00e7\u00e3o de Medicina Acess\u00edvel (AAM) comentou que atender aos requisitos de relat\u00f3rios poderia exigir “14 funcion\u00e1rios em tempo integral trabalhando no projeto de relat\u00f3rios durante um per\u00edodo de sete semanas”, estimando que essa equipe adicional poderia custar \u00e0 empresa at\u00e9 US$ 100.000. A AAM salientou ainda que, para al\u00e9m de aumentar o quadro de pessoal, alguns estabelecimentos ter\u00e3o de investir em software novo ou atualizado, pois cumprir estes requisitos \u201cn\u00e3o \u00e9 um processo instant\u00e2neo que possa ser facilmente realizado com base nos sistemas e processos existentes\u201d.<\/p>\n

\n

N\u00e3o tem tempo ou recursos para cumprir os requisitos de Relat\u00f3rios da Lei CARES? A Registrar Corp pode ajud\u00e1-lo a enviar seus relat\u00f3rios.<\/h3>\n

A Registrar Corp pode ajudar as empresas farmac\u00eauticas a enviar relat\u00f3rios adequadamente para atender aos requisitos da Lei CARES. Para obter mais informa\u00e7\u00f5es, ligue para +1-757-224-0177, envie um e-mail para info@registrarcorp.com<\/a> ou converse com um consultor regulat\u00f3rio 24 horas por dia em regstaging.wpengine.com\/livechat<\/a>.<\/p>\n

Obtenha Assist\u00eancia<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

A ind\u00fastria farmac\u00eautica est\u00e1 levantando preocupa\u00e7\u00f5es sobre o momento dos novos requisitos de Notifica\u00e7\u00e3o de Medicamentos da Administra\u00e7\u00e3o de Alimentos e Medicamentos (FDA) dos EUA. Os requisitos, criados como parte da Lei de Aux\u00edlio, Al\u00edvio e Seguran\u00e7a Econ\u00f4mica de Coronav\u00edrus (Lei CARES), exigem que os estabelecimentos de medicamentos registrados pela FDA enviem relat\u00f3rios anuais \u00e0<\/p>\n","protected":false},"author":30,"featured_media":54678,"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":[96],"tags":[],"class_list":{"0":"post-54712","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-pt","8":"entry"},"yoast_head":"\nInd\u00fastria Farmac\u00eautica Expressa Preocupa\u00e7\u00e3o com o Prazo para Relat\u00f3rios da Lei CARES - 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=\"Ind\u00fastria Farmac\u00eautica Expressa Preocupa\u00e7\u00e3o com o Prazo para Relat\u00f3rios da Lei CARES\" \/>\n<meta property=\"og:description\" content=\"A ind\u00fastria farmac\u00eautica est\u00e1 levantando preocupa\u00e7\u00f5es sobre o momento dos novos requisitos de Notifica\u00e7\u00e3o de Medicamentos da Administra\u00e7\u00e3o de Alimentos e Medicamentos (FDA) dos EUA. 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