{"id":33466,"date":"2024-12-18T11:43:23","date_gmt":"2024-12-18T10:43:23","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/12\/18\/filippine-nuovo-ordine-per-le-licenze-delle-aziende-sanitarie\/"},"modified":"2024-12-20T10:33:38","modified_gmt":"2024-12-20T09:33:38","slug":"filippine-nuovo-ordine-per-le-licenze-delle-aziende-sanitarie","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/12\/18\/filippine-nuovo-ordine-per-le-licenze-delle-aziende-sanitarie\/","title":{"rendered":"Filipinas: nueva orden de concesi\u00f3n de licencias para empresas sanitarias"},"content":{"rendered":"<p style=\"text-align: right;\">19\/12\/2024<\/p>\n<h2>El 22 de noviembre de 2024, la <strong>Administraci\u00f3n de Alimentos y Medicamentos de Filipinas (FDA)<\/strong> promulg\u00f3 la nueva <strong>Orden Administrativa N. 2024-0015 <\/strong>para actualizar las normas, requisitos y procedimientos relacionados con las <strong>licencias para operar (LTO)<\/strong> para empresas farmac\u00e9uticas y de productos sanitarios.<\/h2>\n<p>Esta Orden sustituye a la anterior de 2020, introduciendo directrices m\u00e1s armonizadas y requisitos espec\u00edficos para todas las empresas implicadas en la <strong>producci\u00f3n, importaci\u00f3n, exportaci\u00f3n, venta y gesti\u00f3n<\/strong> de productos sanitarios. La orden abarca <strong>todos los productos sanitarios<\/strong>, incluidos los que emiten radiaciones, los productos sanitarios para diagn\u00f3stico in vitro, los productos sanitarios a medida y los productos reprocesados. Las empresas deben cumplir <strong>los requisitos<\/strong> <strong>t\u00e9cnicos de evaluaci\u00f3n de la conformidad<\/strong>, incluida la <strong>inspecci\u00f3n de f\u00e1bricas <\/strong>por la FDA filipina, para garantizar la seguridad y calidad de los productos sanitarios comercializados.<\/p>\n<p>Entre los objetivos de la nueva orden figuran:<\/p>\n<ul>\n<li><strong>Prescribir normas, requisitos y procedimientos actualizados<\/strong> para la solicitud inicial, la renovaci\u00f3n y la variaci\u00f3n de las licencias de explotaci\u00f3n (LTO) a trav\u00e9s del sistema eServices Portal de la FDA.<\/li>\n<li><strong>En consonancia con las normas internacionales aceptadas y las nuevas normativas locales<\/strong>, mejorar las estructuras, los procesos y los mecanismos para las solicitudes de LTO.<\/li>\n<li><strong>Ampliar los periodos de validez<\/strong> de las licencias de explotaci\u00f3n y establecer mecanismos de revisi\u00f3n administrativa en los procesos reguladores.<\/li>\n<\/ul>\n<p>Los nuevos <strong>periodos de validez de las LTO se ampl\u00edan<\/strong>: para las medianas empresas, la duraci\u00f3n es de hasta seis a\u00f1os para las licencias iniciales y renovadas, mientras que para las grandes empresas es de hasta 12 a\u00f1os. En cambio, las microempresas y las peque\u00f1as empresas obtienen 3 a\u00f1os para las licencias iniciales y 6 a\u00f1os para las renovaciones.<\/p>\n<p>El Reglamento entrar\u00e1 en vigor a <strong>partir de la fecha de su publicaci\u00f3n oficial.<\/strong><\/p>\n<p>A continuaci\u00f3n se indica el calendario de aplicaci\u00f3n:<\/p>\n<ul>\n<li>Las solicitudes de Licencia de Explotaci\u00f3n (LTO) existentes y pendientes recibidas antes de la entrada en vigor se tramitar\u00e1n conforme a lo dispuesto en la anterior DOH AO n.\u00ba 2020-0017 hasta que se agoten las solicitudes.<\/li>\n<li>Las nuevas solicitudes de modificaci\u00f3n de importancia mayor o menor estar\u00e1n sujetas a las directrices actualizadas establecidas en el nuevo reglamento a partir de su entrada en vigor.<\/li>\n<li>La inspecci\u00f3n previa para la licencia se mantiene para los fabricantes de productos sanitarios y se exigir\u00e1 a los dem\u00e1s establecimientos farmac\u00e9uticos en un plazo de cinco a\u00f1os a partir de la entrada en vigor de la Orden. La FDA notificar\u00e1 el pliego de condiciones de la inspecci\u00f3n preliminar si el per\u00edodo es inferior a cinco a\u00f1os.<\/li>\n<li>Los cambios para la lista de fuentes\/proveedores\/clientes ser\u00e1n efectivos inmediatamente para los fabricantes de productos farmac\u00e9uticos en el momento de su entrada en vigor, mientras que para otros productos sanitarios se aplicar\u00e1 un periodo transitorio de un a\u00f1o.<\/li>\n<li>Una fase piloto en la que participar\u00e1n las partes interesadas durar\u00e1 un m\u00e1ximo de seis meses a partir de la entrada en vigor de la Orden.<\/li>\n<\/ul>\n<p>Estas medidas se establecieron para armonizar las normativas locales con las internacionales, optimizar los procesos reguladores y mejorar la seguridad y eficacia de los productos sanitarios.<br \/>\nPara m\u00e1s informaci\u00f3n, v\u00e9ase la <a href=\"https:\/\/www.fda.gov.ph\/wp-content\/uploads\/2024\/11\/Administrative-Order-No.2024-0015.pdf\"><strong>Orden administrativa<\/strong><\/a> completa.<\/p>\n<p><strong>FUENTE:<\/strong><br \/>\n<a href=\"https:\/\/www.fda.gov.ph\/category\/administrative-order\/\">https:\/\/www.fda.gov.ph\/category\/administrative-order\/<\/a><\/p>\n<p><strong>&gt;&gt;&gt;\u00a0<\/strong>El equipo de expertos de Thema est\u00e1 preparado para proporcionar asistencia integral a las empresas de fabricaci\u00f3n en relaci\u00f3n con todos los <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><strong>requisitos reglamentarios<\/strong><\/a> necesarios para entrar en los mercados asi\u00e1ticos.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>19\/12\/2024 El 22 de noviembre de 2024, la Administraci\u00f3n de Alimentos y Medicamentos de Filipinas (FDA) promulg\u00f3 la nueva Orden Administrativa  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33417,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-33466","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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