{"id":30802,"date":"2025-09-08T08:53:40","date_gmt":"2025-09-08T11:53:40","guid":{"rendered":"https:\/\/victoriaaldia.com\/?p=30802"},"modified":"2025-09-08T08:53:40","modified_gmt":"2025-09-08T11:53:40","slug":"la-anmat-exige-estudios-de-bioequivalencia-para-medicamentos-contra-la-diabetes","status":"publish","type":"post","link":"https:\/\/victoriaaldia.com\/?p=30802","title":{"rendered":"La ANMAT exige estudios de bioequivalencia para medicamentos contra la diabetes"},"content":{"rendered":"<h2>Bolet\u00edn Oficial<\/h2>\n<header class=\"cl-24 header-interior interior-top-1\">La ANMAT dispuso que f\u00e1rmacos con nuevos ingredientes activos para la diabetes realicen estudios de biodisponibilidad y bioequivalencia en un plazo de 180 d\u00edas. De no cumplir con los resultados, la comercializaci\u00f3n ser\u00e1 suspendida.<\/header>\n<header><\/header>\n<header>La Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (ANMAT) reforz\u00f3 los controles sobre los medicamentos utilizados en el tratamiento de la diabetes. A trav\u00e9s de la Disposici\u00f3n N\u00ba 6559\/2025, publicada en el Bolet\u00edn Oficial, se estableci\u00f3 que todos los hipoglucemiantes orales de categor\u00edas II y IV que contengan nuevos ingredientes activos deber\u00e1n someterse a estudios de biodisponibilidad y bioequivalencia.<\/p>\n<p>&nbsp;<\/p>\n<p>La normativa fij\u00f3 un plazo m\u00e1ximo de 180 d\u00edas para que los laboratorios presenten los resultados de estas pruebas. En caso de que los medicamentos no demuestren equivalencia con el producto de referencia, la ANMAT ordenar\u00e1 la suspensi\u00f3n autom\u00e1tica de su comercializaci\u00f3n.<\/p>\n<figure class=\"embed\"><img loading=\"lazy\" decoding=\"async\" class=\"lazy\" src=\"https:\/\/elonce-media.elonce.com\/fotos\/2025\/06\/05\/e_1749119623_34502.webp\" alt=\"ANMAT\" width=\"600\" height=\"400\" data-src=\"https:\/\/elonce-media.elonce.com\/fotos\/2025\/06\/05\/e_1749119623_34502.webp\" \/><figcaption>ANMAT<\/figcaption><\/figure>\n<h3>Qu\u00e9 eval\u00faan los estudios exigidos<\/h3>\n<p>La\u00a0<b>bioequivalencia<\/b>\u00a0determina si un medicamento gen\u00e9rico y el original alcanzan el organismo en la misma cantidad y velocidad, garantizando eficacia y seguridad equivalentes. Por su parte, la\u00a0<b>biodisponibilidad<\/b>\u00a0mide la proporci\u00f3n y el tiempo en que el principio activo llega a la sangre tras su administraci\u00f3n, asegurando que la sustancia est\u00e9 disponible para ejercer su efecto terap\u00e9utico.<\/p>\n<p>&nbsp;<\/p>\n<p>Estos par\u00e1metros resultan clave para proteger a los pacientes diab\u00e9ticos, ya que aseguran que los tratamientos mantengan la calidad y efectividad requeridas.<\/p>\n<h3>Otras medidas recientes de la ANMAT<\/h3>\n<p>En paralelo, el organismo ampli\u00f3 el listado de estupefacientes, psicotr\u00f3picos y otras sustancias incluidas en el\u00a0<b>Sistema Nacional de Trazabilidad<\/b>, con el fin de reforzar la seguridad de los medicamentos distribuidos en el pa\u00eds. Hasta el momento, la trazabilidad de sustancias como morfina, fentanilo, ketamina o cannabidiol se realizaba de manera parcial y con documentaci\u00f3n en papel a nivel provincial.<\/p>\n<p>&nbsp;<\/p>\n<p>Adem\u00e1s, semanas atr\u00e1s la ANMAT dispuso la\u00a0<b>inhibici\u00f3n de la firma Rigecin Labs S.A.<\/b>, tras detectar incumplimientos en Buenas Pr\u00e1cticas de Fabricaci\u00f3n. Como consecuencia, se prohibi\u00f3 la comercializaci\u00f3n y distribuci\u00f3n de varias soluciones parenterales y se orden\u00f3 el retiro de lotes sospechados de contaminaci\u00f3n.\u00a0<i>(Fuente: Infobae)<\/i><\/p>\n<p><iframe loading=\"lazy\" title=\"La ANMAT exige estudios de bioequivalencia para medicamentos contra la diabetes\" class=\"scribd_iframe_embed\" src=\"https:\/\/www.scribd.com\/embeds\/913450649\/content\" data-aspect-ratio=\"0.7080062794348508\" scrolling=\"no\" id=\"913450649\" width=\"1000\" height=\"1000\" frameborder=\"0\"><\/iframe><script type=\"text\/javascript\">          (function() { var scribd = document.createElement(\"script\"); scribd.type = \"text\/javascript\"; scribd.async = true; scribd.src = \"https:\/\/www.scribd.com\/javascripts\/embed_code\/inject.js\"; var s = document.getElementsByTagName(\"script\")[0]; s.parentNode.insertBefore(scribd, s); })()        <\/script><\/p>\n<h3>Una reforma integral en marcha<\/h3>\n<p>Estas disposiciones se enmarcan en la\u00a0<b>refuncionalizaci\u00f3n de la ANMAT<\/b> que impulsa el Ministerio de Salud. El plan busca concentrar los esfuerzos de fiscalizaci\u00f3n en medicamentos, alimentos y dispositivos m\u00e9dicos, mientras que el control de la industria cosm\u00e9tica pasar\u00e1 a un esquema descentralizado. Fuente: El Once<\/p>\n<p><a href=\"https:\/\/victoriaaldia.com\/el-rio-llego-al-nivel-mas-alto-en-lo-que-va-de-2023-en-parana-y-seguira-subiendo\/coopar\/\" rel=\"attachment wp-att-9276\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9276\" src=\"http:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar.png\" alt=\"\" width=\"720\" height=\"90\" srcset=\"https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar.png 720w, https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar-300x38.png 300w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><\/a><\/p>\n<p>}<\/p>\n<p>&nbsp;<\/p>\n<\/header>\n","protected":false},"excerpt":{"rendered":"<p>Bolet\u00edn Oficial La ANMAT dispuso que f\u00e1rmacos con nuevos ingredientes activos para la diabetes realicen estudios de biodisponibilidad y bioequivalencia en un plazo de 180 d\u00edas. De no cumplir con los resultados, la comercializaci\u00f3n ser\u00e1 suspendida. La Administraci\u00f3n Nacional de&#8230;<\/p>\n","protected":false},"author":3,"featured_media":30803,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,17],"tags":[],"class_list":["post-30802","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nacionales","category-noticias","category-sociedad"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>La ANMAT exige estudios de bioequivalencia para medicamentos contra la diabetes - Victoria Al D\u00eda<\/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:\/\/victoriaaldia.com\/?p=30802\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La ANMAT exige estudios de bioequivalencia para medicamentos contra la diabetes - Victoria Al D\u00eda\" \/>\n<meta property=\"og:description\" content=\"Bolet\u00edn Oficial La ANMAT dispuso que f\u00e1rmacos con nuevos ingredientes activos para la diabetes realicen estudios de biodisponibilidad y bioequivalencia en un plazo de 180 d\u00edas. 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