{"id":4726,"date":"2024-01-12T17:13:52","date_gmt":"2024-01-12T09:13:52","guid":{"rendered":"https:\/\/regask.com\/?p=4726"},"modified":"2024-11-19T10:16:10","modified_gmt":"2024-11-19T02:16:10","slug":"guia-sobre-biosimilares-de-malasia","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/malaysia-biosimilar-guidance\/","title":{"rendered":"La NPRA public\u00f3 un documento de orientaci\u00f3n y pautas para la reg\u2026"},"content":{"rendered":"<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">La NPRA ha publicado una edici\u00f3n revisada de las pautas de registro de productos biosimilares en la segunda edici\u00f3n del Documento de orientaci\u00f3n y pautas para el registro de biosimilares en Malasia (diciembre de 2023).<\/div>\n<\/div>\n<div><\/div>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">En consonancia con las directrices de la OMS sobre biosimilares de 2022, los cambios clave ofrecen mayor claridad sobre\u2026<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t<div id=\"gap-200976955\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-200976955 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_2026826042\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-1786708737\">\n\n\t<div id=\"col-1611606348\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<section class=\"section\" id=\"section_691403837\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1304626241\">\n\n\n\t<div id=\"col-251878140\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2>Lo sentimos, este contenido premium es solo para clientes de RegASK.<\/h2>\n<p>\u00bfQuieres acceder a todo el contenido de la alerta o navegar por todas las noticias?\u00a0<\/p>\n<div class=\"row\"  id=\"row-2066069169\">\n\n\n\t<div id=\"col-112224695\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<a href=\"https:\/\/app.RegASK.com\/#\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Inicio de sesi\u00f3n del cliente<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/solicitar-una-demostracion\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>Reservar una demostraci\u00f3n<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Navegar por las noticias<\/span>\n\t<\/a>\n\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_691403837 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n<\/style>\n\t<\/section>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_2026826042 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  margin-bottom: -100px;\n  background-color: rgb(0, 49, 117);\n}\n<\/style>\n\t<\/section>\n\t\n\t<div id=\"gap-2056737891\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2056737891 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>The NPRA has released a revised edition of the biosimilar product registration guidelines in the second edition of the Guidance Document and Guidelines for Registration of Biosimilars in Malaysia (December 2023). Aligned with the 2022 WHO biosimilar guideline, the key changes offer enhanced clarity on&#8230; &nbsp;<\/p>","protected":false},"author":39,"featured_media":4716,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,584],"tags":[56,165,265],"class_list":["post-4726","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-malaysia-regulations","tag-premium-news","tag-public-health","tag-biosimilar"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Malaysia: Biosimilar Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"Malaysia&#039;s NPRA publishes a new biosimilar guidance document and guidelines. 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