{"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":"mfd-vorschriften-zur-arzneimittelsicherheit","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/mfds-pharmaceutical-safety-regs\/","title":{"rendered":"MFDS schl\u00e4gt eine teilweise \u00dcberarbeitung der Vorschriften zum Sa\u2026 vor."},"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\">Koreanisches Ministerium f\u00fcr Lebensmittel- und Arzneimittelsicherheit (MFDS)<\/a> schlug eine Teil\u00fcberarbeitung der Arzneimittelsicherheitsverordnung mit der Sicherheitsmitteilung Nr. 2023-333 vor. Nachfolgend finden Sie eine Zusammenfassung des vorgeschlagenen Entwurfs:<\/div>\n<div><\/div>\n<ul>\n<li>Erweiterung des Geltungsbereichs der f\u00fcr die Registrierung von Rohstoffarzneimitteln eingereichten Daten (Artikel 15 und 16)<\/li>\n<li>Die zum Zeitpunkt der Registrierung des Ausgangsarzneimittels \u00fcbermittelten Daten zum Herstellungsort des Ausgangsarzneimittels werden um Daten erweitert, die bescheinigen, dass die Herstellungs- und Qualit\u00e4tskontrollstandards des Ausgangsarzneimittels angemessen sind, oder um Daten, die vom MFDS als Herstellungszertifikat oder als gleichwertig anerkannt werden.<\/li>\n<li>Vorschriften zu Verfahren und Methoden f\u00fcr die Zulassung der therapeutischen Verwendung neuer Pr\u00fcfpr\u00e4parate im Ausland (Artikel 28(2))<\/li>\n<li>Da der Umfang der f\u00fcr die therapeutische Verwendung zulassungspflichtigen neuen Pr\u00fcfpr\u00e4parate um neue Pr\u00fcfpr\u00e4parate aus dem Ausland erweitert wurde, wurden Regelungen zu Antragsverfahren und Einreichungsunterlagen erstellt.<\/li>\n<li>Regelung von Angelegenheiten, die keine geringf\u00fcgigen \u00c4nderungen sind und f\u00fcr die keine GMP-\u00c4nderungsgenehmigung erforderlich ist (Artikel 48.3)<\/li>\n<li>Da die Vorgaben f\u00fcr geringf\u00fcgige \u00c4nderungen minimal und die Vorgaben f\u00fcr die \u00c4nderungsgenehmigung breit gef\u00e4chert sind, werden wesentliche \u00c4nderungen, die die Qualit\u00e4t des Arzneimittels beeintr\u00e4chtigen k\u00f6nnen, als keine geringf\u00fcgigen \u00c4nderungen eingestuft und unterliegen der \u00c4nderungsgenehmigung.<\/li>\n<li>Vorschriften \u00fcber Kennzeichnungsmethoden und -standards f\u00fcr Arzneimittel und andere Mittel f\u00fcr Seh- und H\u00f6rgesch\u00e4digte (Artikel 71(2), 75(2) und 75(3))<\/li>\n<li>Da es nun verpflichtend ist, auf Arzneimitteln und Arzneimittelersatzprodukten, die vom MFDS f\u00fcr Seh- und H\u00f6rgesch\u00e4digte verschrieben werden, Braille- und audiovisuelle Konvertierungscodes anzubringen, legen die Vorschriften Methoden und Standards f\u00fcr derartige Kennzeichnungen sowie Inhalte und Methoden f\u00fcr Umfragen und Bewertungen hinsichtlich ihrer Eignung fest.<\/li>\n<li>Vorschriften zu Methoden und Verfahren f\u00fcr die Online-\u00dcberwachung des illegalen Drogenverkaufs (neuer Artikel 71.3)<\/li>\n<li>Da die Grundlage f\u00fcr die Beauftragung einer Online-\u00dcberwachung des illegalen Arzneimittelverkaufs geschaffen wurde, wurden Vorschriften zu \u00dcberwachungsmethoden und -verfahren ausgearbeitet.<\/li>\n<\/ul>\n<div>Die \u00f6ffentliche Konsultation ist bis zum 11. September 2023 ge\u00f6ffnet.<\/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\/de\/kontakt\/\">Kontaktieren Sie RegASK, um mehr \u00fcber Regulierungs\u00e4nderungen in S\u00fcdkorea zu erfahren.\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\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/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>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1869905563\">\n\n\t<div id=\"col-1712314873\" 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\/de\/fallstudien\/ressourcen-fallstudien-pharma-biotech\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Pharma- und Biotech-Industrie<\/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>Korea Ministry of Food and Drug Safety (MFDS) proposed a partial revision to Regulations on the Safety of Pharmaceuticals through Safety Notice No. 2023-333. Below is a summary of the proposed draft: Expanding the scope of recognition of data submitted for registration of raw material drugs (Articles 15 and 16) The data submitted on the&#8230;<\/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 v28.0 (Yoast SEO v28.1) - 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. Stay informed with RegASK&#039;s expert analysis.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/mfd-vorschriften-zur-arzneimittelsicherheit\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MFDS Proposed Partial Revision of Regulations on the Safety of Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"The MFDS proposes revisions to pharmaceutical safety regulations. Stay informed with RegASK&#039;s expert analysis.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/mfd-vorschriften-zur-arzneimittelsicherheit\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-07-25T06:37:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-25T18:49:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\" \/>\n\t<meta property=\"og:image:width\" content=\"331\" \/>\n\t<meta property=\"og:image:height\" content=\"301\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"MFDS Proposed Partial Revision of Regulations on the Sa&hellip;\",\"datePublished\":\"2023-07-25T06:37:49+00:00\",\"dateModified\":\"2024-10-25T18:49:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/\"},\"wordCount\":414,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Pharma and Biotech\",\"South Korea\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/\",\"name\":\"MFDS: Pharmaceutical Safety Updates | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\",\"datePublished\":\"2023-07-25T06:37:49+00:00\",\"dateModified\":\"2024-10-25T18:49:58+00:00\",\"description\":\"The MFDS proposes revisions to pharmaceutical safety regulations. Stay informed with RegASK's expert analysis.\",\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/regask.com\\\/mfds-pharmaceutical-safety-regs\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png\",\"width\":331,\"height\":301,\"caption\":\"Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"MFDS: Updates zur Arzneimittelsicherheit | RegASK","description":"Das MFDS schl\u00e4gt \u00c4nderungen der Arzneimittelsicherheitsvorschriften vor. Bleiben Sie mit der Expertenanalyse von RegASK auf dem Laufenden.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/de\/mfd-vorschriften-zur-arzneimittelsicherheit\/","og_locale":"de_DE","og_type":"article","og_title":"MFDS Proposed Partial Revision of Regulations on the Safety of Pharmaceuticals","og_description":"The MFDS proposes revisions to pharmaceutical safety regulations. Stay informed with RegASK's expert analysis.","og_url":"https:\/\/regask.com\/de\/mfd-vorschriften-zur-arzneimittelsicherheit\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2023-07-25T06:37:49+00:00","article_modified_time":"2024-10-25T18:49:58+00:00","og_image":[{"width":331,"height":301,"url":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"2\u00a0Minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/#article","isPartOf":{"@id":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"MFDS Proposed Partial Revision of Regulations on the Sa&hellip;","datePublished":"2023-07-25T06:37:49+00:00","dateModified":"2024-10-25T18:49:58+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/"},"wordCount":414,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","keywords":["Latest Insights"],"articleSection":["Pharma and Biotech","South Korea"],"inLanguage":"de"},{"@type":"WebPage","@id":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/","url":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/","name":"MFDS: Updates zur Arzneimittelsicherheit | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","datePublished":"2023-07-25T06:37:49+00:00","dateModified":"2024-10-25T18:49:58+00:00","description":"Das MFDS schl\u00e4gt \u00c4nderungen der Arzneimittelsicherheitsvorschriften vor. Bleiben Sie mit der Expertenanalyse von RegASK auf dem Laufenden.","inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/"]}]},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/regask.com\/mfds-pharmaceutical-safety-regs\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2022\/12\/Amendment-to-the-Clinical-Trials-Regulation-CTR-on-Investigational-Medicinal-Products-IMPs-Labelling.png","width":331,"height":301,"caption":"Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Das regulatorische KI-Betriebssystem f\u00fcr leistungsstarke Teams","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Benoit Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts\/4334","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/comments?post=4334"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts\/4334\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/media\/4047"}],"wp:attachment":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/media?parent=4334"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/categories?post=4334"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/tags?post=4334"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}