{"id":7504,"date":"2024-08-22T20:14:17","date_gmt":"2024-08-22T12:14:17","guid":{"rendered":"https:\/\/regask.com\/?p=7504"},"modified":"2025-01-09T03:26:17","modified_gmt":"2025-01-08T19:26:17","slug":"directrices-de-etiquetado-de-medicamentos-de-la-fda-de-tailandia","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/thailand-fda-drug-labeling-guidelines\/","title":{"rendered":"La FDA de Tailandia mejora las normas de etiquetado de medicamentos y PIL: Nuevo..."},"content":{"rendered":"<p>El 20 de agosto de 2024, la Administraci\u00f3n de Alimentos y Medicamentos (FDA) de Tailandia emiti\u00f3 una importante actualizaci\u00f3n de las directrices para el registro de f\u00f3rmulas farmac\u00e9uticas modernas presentadas electr\u00f3nicamente, establecidas originalmente el 23 de junio de 2023. Esta actualizaci\u00f3n revisa espec\u00edficamente los est\u00e1ndares de etiquetado y prospectos de informaci\u00f3n para el paciente (PIL) en ciertas categor\u00edas de medicamentos, con el objetivo de agilizar el proceso de registro y garantizar que la informaci\u00f3n al consumidor sea clara, accesible y acorde con los est\u00e1ndares internacionales. Se espera que esta revisi\u00f3n mejore la competitividad de la industria farmac\u00e9utica de Tailandia y mejore el acceso p\u00fablico a medicamentos esenciales.<\/p>\n<p>Las directrices actualizadas se centran en perfeccionar el etiquetado y los prospectos de informaci\u00f3n al paciente de los medicamentos modernos mediante:<\/p>\n<ul>\n<li><strong>Pruebas de usuarios p\u00fablicos para PIL<\/strong>:La actualizaci\u00f3n exige que en el caso de los medicamentos de uso dom\u00e9stico, as\u00ed como de los f\u00e1rmacos no clasificados como peligrosos o bajo control especial, incluidos aquellos recientemente degradados de dichas clasificaciones, los folletos de informaci\u00f3n al paciente deben someterse a pruebas de usuario p\u00fablico.<\/li>\n<li><strong>Especificaciones de prueba<\/strong>:Las pruebas de usuario deben realizarse en materiales que reflejen exactamente el producto final en t\u00e9rminos de tama\u00f1o, calidad del papel, color y estilo de fuente. Se debe compilar y enviar un informe de prueba completo para los PIL.<\/li>\n<\/ul>\n<p>Este ajuste tiene como objetivo garantizar que la informaci\u00f3n proporcionada en las etiquetas y los PIL sea clara, f\u00e1cil de entender y verificada por el p\u00fablico, promoviendo as\u00ed el autocuidado y la prevenci\u00f3n de enfermedades en l\u00ednea con las necesidades sociales de Tailandia.<\/p>\n<p>La actualizaci\u00f3n supone un cambio importante para los medicamentos de uso dom\u00e9stico y otros medicamentos no peligrosos o que no est\u00e1n sujetos a controles especiales, en particular los recientemente reclasificados. Ahora las empresas farmac\u00e9uticas deben realizar pruebas de uso p\u00fablico de los folletos informativos, a fin de garantizar que estos materiales informativos cumplan con los est\u00e1ndares de comprensi\u00f3n p\u00fablica.<\/p>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" class=\"button primary is-link is-medium\" rel=\"noopener\" >\n\t\t<span>Para leer m\u00e1s<\/span>\n\t<\/a>\n\n<p>\u00a9Esta alerta de registro es emitida por RegASK<\/p>","protected":false},"excerpt":{"rendered":"<p>El 20 de agosto de 2024, la Administraci\u00f3n de Alimentos y Medicamentos (FDA) de Tailandia emiti\u00f3 una importante actualizaci\u00f3n de las directrices para el registro electr\u00f3nico de f\u00f3rmulas de medicamentos modernos, establecidas originalmente el 23 de junio de 2023. Esta actualizaci\u00f3n revisa espec\u00edficamente los est\u00e1ndares de etiquetado y prospectos de informaci\u00f3n para el paciente (PIL) en ciertas categor\u00edas de medicamentos, con el objetivo de agilizar el proceso de registro.<\/p>","protected":false},"author":22,"featured_media":7514,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,535],"tags":[177,299,474,479,480],"class_list":["post-7504","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-thailand-regulations","tag-labelling","tag-regulatory-intelligence","tag-product-compliance","tag-household-medicine","tag-product-information-leaflet"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Thailand 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