{"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":"directives-sur-les-biosimilaires-en-malaisie","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/malaysia-biosimilar-guidance\/","title":{"rendered":"La NPRA a publi\u00e9 un document d\u2019orientation et des lignes directrices pour la r\u00e9glementation\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 a publi\u00e9 une \u00e9dition r\u00e9vis\u00e9e des directives d&#039;enregistrement des produits biosimilaires dans la deuxi\u00e8me \u00e9dition du document d&#039;orientation et des directives pour l&#039;enregistrement des biosimilaires en Malaisie (d\u00e9cembre 2023).<\/div>\n<\/div>\n<div><\/div>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">Conform\u00e9ment \u00e0 la directive 2022 de l\u2019OMS sur les biosimilaires, les principaux changements offrent une plus grande clart\u00e9 sur\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-875713597\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-875713597 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_1841278458\">\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-2048141539\">\n\n\t<div id=\"col-297331974\" 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_1954873065\">\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-313483350\">\n\n\n\t<div id=\"col-311036560\" 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>D\u00e9sol\u00e9, ce contenu premium est r\u00e9serv\u00e9 aux clients RegASK uniquement.<\/h2>\n<p>Vous souhaitez acc\u00e9der \u00e0 l&#039;int\u00e9gralit\u00e9 du contenu de l&#039;alerte ou parcourir toutes les actualit\u00e9s ?\u00a0<\/p>\n<div class=\"row\"  id=\"row-1597537606\">\n\n\n\t<div id=\"col-2137869203\" 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>Connexion client<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/fr\/demander-une-demo\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>R\u00e9server une d\u00e9mo<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/fr\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Parcourir les actualit\u00e9s<\/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_1954873065 {\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_1841278458 {\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-1731715006\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1731715006 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>L\u2019Agence nationale de r\u00e9glementation des m\u00e9dicaments (NPRA) a publi\u00e9 une version r\u00e9vis\u00e9e des lignes directrices relatives \u00e0 l\u2019enregistrement des produits biosimilaires dans la deuxi\u00e8me \u00e9dition du Document d\u2019orientation et des Lignes directrices pour l\u2019enregistrement des biosimilaires en Malaisie (d\u00e9cembre 2023). Conform\u00e9ment aux lignes directrices de l\u2019OMS de 2022 sur les biosimilaires, les principales modifications apport\u00e9es apportent davantage de clart\u00e9 sur\u2026 &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 v28.5 (Yoast SEO v28.6) - 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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