{"id":4334,"date":"2023-07-25T14:37:49","date_gmt":"2023-07-25T06:37:49","guid":{"rendered":"https:\/\/regask.com\/?p=4334"},"modified":"2024-10-26T02:49:58","modified_gmt":"2024-10-25T18:49:58","slug":"reglementations-de-securite-pharmaceutique-du-mfd","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/mfds-pharmaceutical-safety-regs\/","title":{"rendered":"Le MFDS a propos\u00e9 une r\u00e9vision partielle de la r\u00e9glementation sur le S\u2026"},"content":{"rendered":"<div>\n<div class=\"css-xdofzv\">\n<div id=\"alert__details__read__summary\" class=\"css-25930v\">\n<div class=\"css-xdofzv\">\n<div id=\"alert__details__read__summary\" class=\"css-25930v\">\n<div><a href=\"https:\/\/www.mfds.go.kr\/eng\/index.do\" target=\"_blank\" rel=\"noopener\">Minist\u00e8re cor\u00e9en de la s\u00e9curit\u00e9 alimentaire et pharmaceutique (MFDS)<\/a> a propos\u00e9 une r\u00e9vision partielle du R\u00e8glement sur la s\u00e9curit\u00e9 des produits pharmaceutiques par le biais de l&#039;avis de s\u00e9curit\u00e9 n\u00b0 2023-333. Vous trouverez ci-dessous un r\u00e9sum\u00e9 du projet propos\u00e9 :<\/div>\n<div><\/div>\n<ul>\n<li>\u00c9largissement du champ de reconnaissance des donn\u00e9es soumises pour l&#039;enregistrement des mati\u00e8res premi\u00e8res pharmaceutiques (articles 15 et 16)<\/li>\n<li>Les donn\u00e9es soumises sur le site de fabrication de la mati\u00e8re premi\u00e8re pharmaceutique au moment de l&#039;enregistrement de la mati\u00e8re premi\u00e8re pharmaceutique seront \u00e9largies pour inclure des donn\u00e9es certifiant que les normes de fabrication et de contr\u00f4le de la qualit\u00e9 de la mati\u00e8re premi\u00e8re pharmaceutique sont appropri\u00e9es, ou des donn\u00e9es reconnues par le MFDS comme un certificat de fabrication ou un \u00e9quivalent en tant que tel.<\/li>\n<li>R\u00e8glement sur les proc\u00e9dures et m\u00e9thodes d&#039;approbation de l&#039;utilisation th\u00e9rapeutique de nouveaux m\u00e9dicaments exp\u00e9rimentaux \u00e0 l&#039;\u00e9tranger (article 28(2))<\/li>\n<li>\u00c9tant donn\u00e9 que le champ d&#039;application des nouveaux m\u00e9dicaments exp\u00e9rimentaux soumis \u00e0 l&#039;approbation pour une utilisation th\u00e9rapeutique a \u00e9t\u00e9 \u00e9largi pour inclure les nouveaux m\u00e9dicaments exp\u00e9rimentaux \u00e9trangers, des r\u00e9glementations sur les proc\u00e9dures de demande et les documents de soumission ont \u00e9t\u00e9 \u00e9labor\u00e9es.<\/li>\n<li>R\u00e9glementation des questions autres que les modifications mineures qui ne n\u00e9cessitent pas l&#039;approbation des modifications des BPF (article 48.3)<\/li>\n<li>\u00c9tant donn\u00e9 que les objectifs en mati\u00e8re de changements mineurs sont minimes et que les objectifs en mati\u00e8re d\u2019approbation de changement sont larges, les changements importants susceptibles d\u2019affecter la qualit\u00e9 du m\u00e9dicament sont consid\u00e9r\u00e9s comme autres que des changements mineurs et sont sujets \u00e0 une approbation de changement.<\/li>\n<li>R\u00e8glement sur les m\u00e9thodes et normes d&#039;\u00e9tiquetage des m\u00e9dicaments et des produits non m\u00e9dicamenteux destin\u00e9s aux malvoyants et aux malentendants (articles 71(2), 75(2) et 75(3))<\/li>\n<li>Comme il est d\u00e9sormais obligatoire de marquer les codes de conversion en braille et audiovisuels sur les m\u00e9dicaments et quasi-m\u00e9dicaments prescrits par le MFDS pour les malvoyants et les malentendants, le r\u00e8glement pr\u00e9voit des m\u00e9thodes et des normes pour ces marquages, ainsi que le contenu et les m\u00e9thodes des enqu\u00eates et des \u00e9valuations pour savoir s&#039;ils sont appropri\u00e9s.<\/li>\n<li>R\u00e8glement sur les m\u00e9thodes et proc\u00e9dures de surveillance en ligne des ventes ill\u00e9gales de drogues (nouvel article 71.3)<\/li>\n<li>Les bases pour confier la surveillance en ligne des ventes ill\u00e9gales de m\u00e9dicaments \u00e9tant \u00e9tablies, des r\u00e9glementations sur les m\u00e9thodes et proc\u00e9dures de surveillance ont \u00e9t\u00e9 \u00e9labor\u00e9es.<\/li>\n<\/ul>\n<div>La consultation publique est ouverte jusqu&#039;au 11 septembre 2023.<\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-md-12\">\n<div class=\"jss1501\">\n<div class=\"jss1521\">\n<div class=\"jss409 jss434 summaryParagraph\">\n<div>\n<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 r\u00e9glementaires en Cor\u00e9e du Sud.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\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.fda.gov\/regulatory-information\/search-fda-guidance-documents\/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act\" 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-827788556\">\n\n\t<div id=\"col-307976195\" 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>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-xs-12\">\n<div class=\"jss1500\">\n<div class=\"jss409 jss417 dataText\"><\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Le minist\u00e8re cor\u00e9en de la S\u00e9curit\u00e9 alimentaire et pharmaceutique (MFDS) a propos\u00e9 une r\u00e9vision partielle du R\u00e8glement sur la s\u00e9curit\u00e9 des produits pharmaceutiques par le biais de l&#039;avis de s\u00e9curit\u00e9 n\u00b0 2023-333. Vous trouverez ci-dessous un r\u00e9sum\u00e9 du projet propos\u00e9 : \u00c9largissement du champ de reconnaissance des donn\u00e9es soumises pour l&#039;enregistrement des mati\u00e8res premi\u00e8res pharmaceutiques (articles 15 et 16) Les donn\u00e9es soumises sur le site\u2026<\/p>","protected":false},"author":39,"featured_media":4047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,520],"tags":[40],"class_list":["post-4334","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-south-korea-regulations","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MFDS: Pharmaceutical Safety Updates | RegASK<\/title>\n<meta name=\"description\" content=\"The MFDS proposes revisions to pharmaceutical safety regulations. 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