{"id":8210,"date":"2025-03-21T10:18:04","date_gmt":"2025-03-21T10:18:04","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8210"},"modified":"2025-03-21T10:18:04","modified_gmt":"2025-03-21T10:18:04","slug":"regulacao-de-medicamentos-na-uniao-europeia-ate-2028","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/pt-pt\/regulacao-de-medicamentos-na-uniao-europeia-ate-2028\/","title":{"rendered":"EMA e HMA Apresentam Estrat\u00e9gia para Regula\u00e7\u00e3o de Medicamentos na Uni\u00e3o Europeia at\u00e9 2028"},"content":{"rendered":"
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A Ag\u00eancia Europeia de Medicamentos (EMA) e os Chefes das Ag\u00eancias de Medicamentos (HMA) divulgaram, recentemente, a nova Estrat\u00e9gia da Rede Europeia de Ag\u00eancias de Medicamentos para 2028 (EMANS 2028)<\/strong>, um documento que delineia as prioridades para a regula\u00e7\u00e3o de medicamentos na Uni\u00e3o Europeia nos pr\u00f3ximos anos. Esta estrat\u00e9gia visa responder aos desafios e necessidades do setor farmac\u00eautico e refor\u00e7ar a competitividade da UE no desenvolvimento e fabrico de medicamentos, ao mesmo tempo que garante acesso seguro e equitativo a tratamentos inovadores.<\/p>\n

Objetivos da EMANS 2028<\/strong><\/h3>\n

A estrat\u00e9gia, intitulada “Aproveitar oportunidades num cen\u00e1rio em mudan\u00e7a”<\/strong>, tem como principal objetivo atualizar o plano anterior (2021-2025)<\/strong>, colocando especial \u00eanfase no uso de tecnologias emergentes, como a intelig\u00eancia artificial<\/strong> e a digitaliza\u00e7\u00e3o<\/strong>, que desempenhar\u00e3o um papel crescente na avalia\u00e7\u00e3o e monitoriza\u00e7\u00e3o de medicamentos ao longo de seu ciclo de vida.<\/p>\n

A nova abordagem tamb\u00e9m incorpora a One Health<\/strong>, uma estrat\u00e9gia que reconhece a interliga\u00e7\u00e3o entre sa\u00fade humana, animal e ambiental, visando uma resposta coordenada a desafios globais.<\/p>\n

Seis \u00c1reas Priorit\u00e1rias da Estrat\u00e9gia<\/strong><\/h3>\n

A EMANS 2028<\/strong> define seis \u00e1reas priorit\u00e1rias que guiar\u00e3o as a\u00e7\u00f5es de regula\u00e7\u00e3o de medicamentos na UE at\u00e9 2028. Estas s\u00e3o as \u00e1reas de atua\u00e7\u00e3o mais urgentes e fundamentais para o desenvolvimento futuro da rede reguladora:<\/p>\n

    \n
  1. Acessibilidade<\/strong>: Facilitar o acesso a medicamentos atrav\u00e9s dos sistemas de sa\u00fade da UE.<\/li>\n
  2. Digitaliza\u00e7\u00e3o e Intelig\u00eancia Artificial<\/strong>: Melhorar a tomada de decis\u00e3o, otimizar processos e aumentar a efici\u00eancia.<\/li>\n
  3. Inova\u00e7\u00e3o e Competitividade<\/strong>: Criar um ambiente regulat\u00f3rio que fomente a investiga\u00e7\u00e3o e a r\u00e1pida tradu\u00e7\u00e3o da inova\u00e7\u00e3o em benef\u00edcios para os doentes.<\/li>\n
  4. Prepara\u00e7\u00e3o para Amea\u00e7as \u00e0 Sa\u00fade<\/strong>: Refor\u00e7ar a capacidade de resposta a emerg\u00eancias, incluindo a resist\u00eancia antimicrobiana.<\/li>\n
  5. Disponibilidade e Seguran\u00e7a do Abastecimento<\/strong>: Garantir um fornecimento est\u00e1vel de medicamentos e a seguran\u00e7a das cadeias de abastecimento.<\/li>\n
  6. Sustentabilidade da Rede Reguladora<\/strong>: Assegurar os recursos necess\u00e1rios para apoiar as decis\u00f5es cient\u00edficas e regulat\u00f3rias, aproveitando os avan\u00e7os tecnol\u00f3gicos.<\/li>\n<\/ol>\n

    Import\u00e2ncia da Estrat\u00e9gia para a Regula\u00e7\u00e3o de Medicamentos<\/strong><\/h4>\n

    Maria Lamas, Presidente do Grupo de Gest\u00e3o dos HMA, destacou a import\u00e2ncia da estrat\u00e9gia para garantir \u201cuma abordagem transparente e orientada para o futuro para a gest\u00e3o das prioridades de sa\u00fade p\u00fablica\u201d<\/strong>. Ela enfatizou que as ag\u00eancias reguladoras europeias devem operar com uma estrat\u00e9gia abrangente<\/strong>, capaz de adaptar-se \u00e0s novas oportunidades para promover a sa\u00fade p\u00fablica e animal.<\/p>\n

    A EMANS 2028<\/strong> tamb\u00e9m ser\u00e1 implementada de acordo com planos de trabalho plurianuais, permitindo um acompanhamento cont\u00ednuo<\/strong> da sua execu\u00e7\u00e3o e ajustes conforme necess\u00e1rio.<\/p>\n

    O Papel do Infarmed na Elabora\u00e7\u00e3o da Estrat\u00e9gia<\/strong><\/h3>\n

    O Infarmed<\/strong>, autoridade portuguesa respons\u00e1vel pela regula\u00e7\u00e3o de medicamentos e produtos de sa\u00fade, teve um papel ativo na elabora\u00e7\u00e3o da EMANS 2028. O presidente da institui\u00e7\u00e3o, Rui Santos Ivo<\/strong>, fez parte da equipa de coordena\u00e7\u00e3o do documento, representando os HMA juntamente com Thomas Hereber da BVL (Alemanha). O Infarmed tamb\u00e9m co-liderou o tema da Disponibilidade e Seguran\u00e7a do Abastecimento<\/strong>, trabalhando com outros especialistas de diferentes pa\u00edses da UE.<\/p>\n

    Rui Santos Ivo destacou a import\u00e2ncia da estrat\u00e9gia<\/strong> para responder aos desafios globais da regula\u00e7\u00e3o<\/strong> e \u00e0 prepara\u00e7\u00e3o para a revis\u00e3o da legisla\u00e7\u00e3o farmac\u00eautica europeia<\/strong>, especialmente no que diz respeito ao acesso e \u00e0 disponibilidade de medicamentos.<\/p>\n

    Pr\u00f3ximos Passos e Implementa\u00e7\u00e3o<\/strong><\/h3>\n

    Com a ado\u00e7\u00e3o da EMANS 2028<\/strong>, a EMA e os HMA agora ir\u00e3o implementar a estrat\u00e9gia, adaptando-a conforme as necessidades do setor e monitorando a sua execu\u00e7\u00e3o de forma cont\u00ednua. A colabora\u00e7\u00e3o internacional<\/strong> ser\u00e1 essencial para garantir a efic\u00e1cia da estrat\u00e9gia e para garantir que a rede de ag\u00eancias reguladoras europeias esteja preparada para enfrentar os desafios da pr\u00f3xima d\u00e9cada.<\/p>\n

    Essa iniciativa n\u00e3o s\u00f3 coloca a UE na vanguarda da regula\u00e7\u00e3o farmac\u00eautica<\/strong>, como tamb\u00e9m assegura que os cidad\u00e3os europeus possam ter acesso a medicamentos seguros e inovadores, promovendo, assim, a sa\u00fade p\u00fablica de forma sustent\u00e1vel e equitativa.<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    A Ag\u00eancia Europeia de Medicamentos (EMA) e os Chefes das Ag\u00eancias de Medicamentos (HMA) divulgaram, recentemente, a nova Estrat\u00e9gia da Rede Europeia de Ag\u00eancias de Medicamentos para 2028 (EMANS 2028), um documento que delineia as prioridades para a regula\u00e7\u00e3o de medicamentos na Uni\u00e3o Europeia nos pr\u00f3ximos anos. Esta estrat\u00e9gia visa responder aos desafios e necessidades do setor farmac\u00eautico e refor\u00e7ar a competitividade da UE no desenvolvimento e fabrico de medicamentos, ao mesmo tempo que garante acesso seguro e equitativo a tratamentos inovadores.<\/p>\n","protected":false},"author":9,"featured_media":8212,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,68,53,60,69],"tags":[90,70],"class_list":["post-8210","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-els","category-els-group","category-geral","category-noticias","category-questoes-regulatorias","tag-ema","tag-medicamentos"],"yoast_head":"\nEstrat\u00e9gia para Regula\u00e7\u00e3o de Medicamentos na Uni\u00e3o Europeia<\/title>\n<meta name=\"description\" content=\"A EMA e os HMA divulgaram, recentemente, a nova Estrat\u00e9gia da Rede Europeia de Ag\u00eancias de Medicamentos para 2028 (EMANS 2028).\" \/>\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=\"Atualizam a lista de medicamentos com exporta\u00e7\u00e3o suspensa\" \/>\n<meta property=\"og:description\" content=\"Atualizam a lista de medicamentos com exporta\u00e7\u00e3o suspensa para garantir o abastecimento de produtos cr\u00edticos.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/els-solutions.com\/pt-pt\/regulacao-de-medicamentos-na-uniao-europeia-ate-2028\/\" \/>\n<meta property=\"og:site_name\" content=\"ELS Group - 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