{"id":3490,"date":"2022-06-08T08:28:01","date_gmt":"2022-06-08T00:28:01","guid":{"rendered":"https:\/\/regask.com\/?p=3490"},"modified":"2024-10-26T07:21:41","modified_gmt":"2024-10-25T23:21:41","slug":"enregistrement-des-produits-therapeutiques-a-singapour","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/singapore-therapeutic-product-registration\/","title":{"rendered":"La HSA de Singapour a mis \u00e0 jour les directives sur les produits th\u00e9rapeutiques\u2026"},"content":{"rendered":"<div>Ils ont r\u00e9vis\u00e9 les listes de contr\u00f4le pour les variations mineures post-approbation (MIV-1 et MIV-2) avec :<\/div>\n<ul>\n<li>Recat\u00e9gorisation de la notification MIV-2 vers la notification MIV-2 (pour la substance m\u00e9dicamenteuse, le produit m\u00e9dicamenteux et les excipients)<\/li>\n<li>Nouvelles listes de contr\u00f4le sous MIV-2 Do-And-Tell et MIV-1<\/li>\n<li>D&#039;autres changements, comme l&#039;extension de la port\u00e9e du changement d&#039;\u00e9tiquetage des produits dans le cadre de Do-And-Tell, par exemple.<\/li>\n<\/ul>\n<div>Ils ont \u00e9tendu le parcours d\u2019\u00e9valuation de l\u2019audit aux produits biologiques, y compris les biosimilaires.<\/div>\n<div><\/div>\n<div>Et enfin, ils ont ajout\u00e9 d\u2019autres mises \u00e0 jour sur les demandes de produits biosimilaires, des modifications mineures\/\u00e9ditoriales aux annexes et des mises \u00e0 jour \u00e9ditoriales aux documents d\u2019orientation.<\/div>\n<div><\/div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/fr\/contact-2\/\">Contactez RegASK pour en savoir plus sur les changements de r\u00e9glementation \u00e0 Singapour.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.hsa.gov.sg\/announcements\/regulatory-updates\/regulatory-updates-for-therapeutic-product-registration\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1372812778\">\n\n\t<div id=\"col-114382059\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-pharma-biotech\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lisez les \u00e9tudes de cas sur l&#039;industrie pharmaceutique et biotechnologique<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>They revised checklists for post-approval minor variations (MIV-1 and MIV-2) with: Re-categorisation from MIV-2 Notification to MIV-2 Do-And-Tell (for Drug Substance, Drug Product, and Excipients) New checklists under MIV-2 Do-And-Tell and MIV-1 Other changes, such as extending the scope of the product labelling change under Do-And-Tell, for example. They extended the audit assessment pathway to&#8230;<\/p>","protected":false},"author":39,"featured_media":2487,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,583],"tags":[40],"class_list":["post-3490","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-singapore-regulations","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Singapore: Therapeutic Product Registration | RegASK<\/title>\n<meta name=\"description\" content=\"The HSA updated its guidance on therapeutic product registration this guidance, They revised checklists for post-approval minor variations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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