{"id":7657,"date":"2024-05-07T11:08:00","date_gmt":"2024-05-07T16:08:00","guid":{"rendered":"https:\/\/fifarma.org\/?p=7657"},"modified":"2024-05-16T15:44:19","modified_gmt":"2024-05-16T20:44:19","slug":"international-recognition-procedure","status":"publish","type":"post","link":"https:\/\/fifarma.org\/pt\/international-recognition-procedure\/","title":{"rendered":"Novos processos Regulat\u00f3rios de Reliance no Reino Unido: Introduzindo o Procedimento de Reconhecimento Internacional (IRP)"},"content":{"rendered":"

Desde o in\u00edcio de 2024, o Reino Unido mudou a forma como aprova medicamentos com algo chamado Procedimento de Reconhecimento Internacional (IRP).<\/p>\n\n\n\n

Este novo sistema de Reliance Regulat\u00f3rio substitui o antigo e \u00e9 projetado para tornar mais r\u00e1pida e f\u00e1cil a aprova\u00e7\u00e3o de medicamentos que j\u00e1 foram aceitos em outros lugares importantes, como Estados Unidos ou Europa.<\/p>\n\n\n\n

O que \u00e9 o IRP e como funciona?<\/strong><\/h4>\n\n\n\n

O IRP permite que empresas que j\u00e1 t\u00eam permiss\u00e3o para vender um medicamento em pa\u00edses reconhecidos solicitem permiss\u00e3o para vend\u00ea-lo no Reino Unido usando as mesmas informa\u00e7\u00f5es que j\u00e1 apresentaram anteriormente. Isso significa que podem pular algumas etapas e fazer com que os medicamentos estejam dispon\u00edveis mais rapidamente para os pacientes brit\u00e2nicos.<\/p>\n\n\n\n

Este sistema abrange v\u00e1rios tipos de medicamentos, incluindo os totalmente novos e os gen\u00e9ricos, mas h\u00e1 certos tipos, como os rem\u00e9dios \u00e0 base de ervas e homeop\u00e1ticos, que n\u00e3o se aplicam aqui.<\/p>\n\n\n\n

Os dois cronogramas de reconhecimento sob o IRP<\/strong><\/h4>\n\n\n\n

O IRP oferece duas rotas de reconhecimento baseadas na antiguidade e complexidade das aprova\u00e7\u00f5es pr\u00e9vias do medicamento:<\/p>\n\n\n\n

    \n
  1. Reconhecimento A (60 dias): Esta via \u00e9 para aplica\u00e7\u00f5es cujas aprova\u00e7\u00f5es por um regulador de refer\u00eancia foram concedidas nos \u00faltimos 2 anos. \u00c9 uma rota r\u00e1pida que n\u00e3o tem pausas no processo, o que significa que a revis\u00e3o \u00e9 conclu\u00edda em 60 dias cont\u00ednuos, a menos que surjam obje\u00e7\u00f5es importantes que exijam mais tempo de revis\u00e3o.

    <\/li>\n\n\n\n
  2. Reconhecimento B (110 dias): Esta rota \u00e9 para aplica\u00e7\u00f5es cujas aprova\u00e7\u00f5es s\u00e3o mais antigas, at\u00e9 10 anos, ou que apresentam situa\u00e7\u00f5es mais complexas, como mudan\u00e7as no processo de fabrica\u00e7\u00e3o ou necessidades espec\u00edficas de gerenciamento de riscos. O processo de Reconhecimento B inclui uma pausa no dia 70, permitindo \u00e0 empresa tempo para responder a quaisquer problemas identificados. Se ainda houver obje\u00e7\u00f5es importantes no final do per\u00edodo, o tempo de revis\u00e3o pode ser estendido.<\/li>\n<\/ol>\n\n\n\n

    Benef\u00edcios do IRP para pacientes e profissionais de sa\u00fade<\/strong><\/h4>\n\n\n\n

    O maior benef\u00edcio do IRP \u00e9 que pode fazer com que medicamentos novos e necess\u00e1rios cheguem mais rapidamente aos pacientes no Reino Unido. Ao usar as informa\u00e7\u00f5es de aprova\u00e7\u00f5es de outros pa\u00edses confi\u00e1veis, a ag\u00eancia reguladora brit\u00e2nica pode se concentrar no mais importante e garantir que tudo esteja em ordem sem atrasar o processo.<\/p>\n\n\n\n

    Isso n\u00e3o s\u00f3 reduz os tempos de espera, mas tamb\u00e9m garante que os pacientes tenham acesso r\u00e1pido aos tratamentos mais recentes e eficazes dispon\u00edveis globalmente.<\/p>\n\n\n\n

    Desafios e considera\u00e7\u00f5es importantes<\/strong><\/h4>\n\n\n\n

    Embora o IRP traga muitos benef\u00edcios, tamb\u00e9m tem seus desafios. \u00c9 vital que as avalia\u00e7\u00f5es feitas por outros pa\u00edses atendam aos padr\u00f5es brit\u00e2nicos de seguran\u00e7a e qualidade. A ag\u00eancia reguladora do Reino Unido ainda pode rejeitar solicita\u00e7\u00f5es se os dados n\u00e3o forem suficientemente bons, destacando a necessidade de documenta\u00e7\u00e3o completa e bem preparada.<\/p>\n\n\n\n

    As empresas farmac\u00eauticas devem entender que o IRP n\u00e3o garante aprova\u00e7\u00e3o autom\u00e1tica e que cada solicita\u00e7\u00e3o ser\u00e1 cuidadosamente revisada para garantir que atenda \u00e0s necessidades espec\u00edficas do Reino Unido. Isso inclui garantir que tudo relacionado \u00e0 fabrica\u00e7\u00e3o e aos controles de seguran\u00e7a seja adequado para os pacientes brit\u00e2nicos.<\/p>\n\n\n\n

    O IRP \u00e9 um grande avan\u00e7o para a regulamenta\u00e7\u00e3o de medicamentos no Reino Unido. Torna o processo mais eficiente e ajuda a que medicamentos importantes cheguem mais rapidamente \u00e0s pessoas que deles necessitam, mantendo sempre um forte compromisso com a seguran\u00e7a dos pacientes. Este sistema n\u00e3o beneficia apenas aqueles que necessitam de medicamentos rapidamente, mas tamb\u00e9m demonstra uma colabora\u00e7\u00e3o mais estreita entre os reguladores de diferentes pa\u00edses, alinhando esfor\u00e7os e padr\u00f5es internacionalmente.<\/p>\n\n\n\n


    Fonte: https:\/\/www.gov.uk\/government\/publications\/international-recognition-procedure\/international-recognition-procedure<\/a><\/p>\n\n

    \n\n\t\t\n
      \n\t\t\t <\/ul>\n <\/div>","protected":false},"excerpt":{"rendered":"

      Desde el comienzo de 2024, el Reino Unido ha cambiado la forma en que aprueba los medicamentos con algo llamado Procedimiento de Reconocimiento Internacional (IRP). Este nuevo sistema de Reliance Regulatorio reemplaza al antiguo y est\u00e1 dise\u00f1ado para hacer m\u00e1s r\u00e1pida y f\u00e1cil la aprobaci\u00f3n de medicamentos que ya han sido aceptados en otros lugares […]<\/p>","protected":false},"author":24,"featured_media":7652,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"enableOnePageScrollInPage":false,"onePageScrollCss":"","onePageScrollSpeed":1000,"onePageScrollAnimation":"easeInOutQuad","onePageScrollShowDotNavigation":true,"onePageScrollNavigation":"scaleUp","onePageScrollNavigationPosition":"right","onePageScrollNavigationHorizontal":[],"onePageScrollNavigationVertical":[],"onePageScrollNavigationSpacing":[],"onePageScrollNavigationColor":"#00ff0d","onePageScrollNavigationColorHover":"#00ff0d","onePageScrollNavigationColorActive":"#00ff0d","onePageScrollNavigationIcon":[],"onePageScrollNavigationWidth":[],"onePageScrollNavigationWidthHover":[],"onePageScrollNavigationWidthActive":[],"onePageScrollNavigationHeight":[],"onePageScrollNavigationHeightHover":[],"onePageScrollNavigationHeightActive":[],"onePageScrollNavigationBorder":[],"onePageScrollNavigationBorderHover":[],"onePageScrollNavigationBorderActive":[],"onePageScrollNavigationBorderRadius":[],"onePageScrollNavigationBorderRadiusHover":[],"onePageScrollNavigationBorderRadiusActive":[],"onePageScrollNavigationTooltipTypography":[],"onePageScrollNavigationTooltipColor":"#ffffff","onePageScrollNavigationTooltipColorHover":"","onePageScrollNavigationTooltipBgColor":"#00ff0d","onePageScrollNavigationTooltipBgColorHover":"","onePageScrollNavigationTooltipPadding":[],"onePageScrollNavigationTooltipPaddingHover":[],"onePageScrollNavigationTooltipBorderRadius":[],"onePageScrollNavigationTooltipBorderRadiusHover":[],"pageSettingsCustomCss":"","footnotes":""},"categories":[149],"tags":[145,144,146],"class_list":["post-7657","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reliance","tag-irp","tag-reino-unido","tag-reliance"],"yoast_head":"\nNuevos procesos de Reliance Regulatorios en el Reino Unido: Introduciendo el Procedimiento de Reconocimiento Internacional (IRP) - FIFARMA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fifarma.org\/pt\/international-recognition-procedure\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nuevos procesos de Reliance Regulatorios en el Reino Unido: Introduciendo el Procedimiento de Reconocimiento Internacional (IRP)\" \/>\n<meta property=\"og:description\" content=\"Desde el comienzo de 2024, el Reino Unido ha cambiado la forma en que aprueba los medicamentos con algo llamado Procedimiento de Reconocimiento Internacional (IRP). 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