{"id":7504,"date":"2024-08-22T20:14:17","date_gmt":"2024-08-22T12:14:17","guid":{"rendered":"https:\/\/regask.com\/?p=7504"},"modified":"2025-01-09T03:26:17","modified_gmt":"2025-01-08T19:26:17","slug":"thailandische-fda-richtlinien-zur-arzneimittelkennzeichnung","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/thailand-fda-drug-labeling-guidelines\/","title":{"rendered":"Die thail\u00e4ndische FDA verbessert die Vorschriften zur Arzneimittelkennzeichnung und Packungsbeilage: Neu \u2026"},"content":{"rendered":"<p>Am 20. August 2024 ver\u00f6ffentlichte die thail\u00e4ndische Food and Drug Administration (FDA) eine wichtige Aktualisierung der Richtlinien f\u00fcr die elektronische Einreichung moderner Arzneimittelformelregistrierungen, die urspr\u00fcnglich am 23. Juni 2023 erstellt wurden. Diese Aktualisierung \u00fcberarbeitet insbesondere die Standards f\u00fcr Kennzeichnung und Packungsbeilagen bestimmter Arzneimittelkategorien. Ziel ist es, den Registrierungsprozess zu vereinfachen und sicherzustellen, dass die Verbraucherinformationen klar, zug\u00e4nglich und internationalen Standards entsprechen. Diese \u00dcberarbeitung soll die Wettbewerbsf\u00e4higkeit der thail\u00e4ndischen Pharmaindustrie st\u00e4rken und den \u00f6ffentlichen Zugang zu wichtigen Medikamenten verbessern.<\/p>\n<p>Der Schwerpunkt der aktualisierten Leitlinien liegt auf der Verbesserung der Kennzeichnung und Patienteninformation moderner Arzneimittel durch:<\/p>\n<ul>\n<li><strong>\u00d6ffentliche Benutzertests f\u00fcr PILs<\/strong>: Die Aktualisierung schreibt vor, dass die Patienteninformationsbrosch\u00fcren f\u00fcr Haushaltsmedikamente sowie f\u00fcr Arzneimittel, die nicht als gef\u00e4hrlich eingestuft sind oder einer besonderen Kontrolle unterliegen \u2013 einschlie\u00dflich derjenigen, deren Einstufung k\u00fcrzlich herabgestuft wurde \u2013, einem \u00f6ffentlichen Anwendertest unterzogen werden m\u00fcssen.<\/li>\n<li><strong>Pr\u00fcfspezifikationen<\/strong>: Die Benutzertests m\u00fcssen auf Materialien durchgef\u00fchrt werden, die dem Endprodukt in Gr\u00f6\u00dfe, Papierqualit\u00e4t, Farbe und Schriftart exakt entsprechen. Ein umfassender Testbericht muss erstellt und f\u00fcr die Produktinformationsbl\u00e4tter eingereicht werden.<\/li>\n<\/ul>\n<p>Mit dieser Anpassung soll sichergestellt werden, dass die in Etiketten und Packungsbeilagen enthaltenen Informationen klar und leicht verst\u00e4ndlich sind und von der \u00d6ffentlichkeit \u00fcberpr\u00fcft werden k\u00f6nnen. Dadurch soll eine Selbstf\u00fcrsorge und Krankheitsvorbeugung gef\u00f6rdert werden, die den gesellschaftlichen Bed\u00fcrfnissen Thailands entspricht.<\/p>\n<p>Die Aktualisierung stellt eine bedeutende \u00c4nderung f\u00fcr Hausarzneimittel und andere ungef\u00e4hrliche oder nicht unter besondere Kontrollma\u00dfnahmen fallende Arzneimittel dar, insbesondere f\u00fcr die k\u00fcrzlich neu eingestuften. Pharmaunternehmen sind nun verpflichtet, \u00f6ffentliche Anwendertests f\u00fcr Packungsbeilagen durchzuf\u00fchren, um sicherzustellen, dass diese Informationsmaterialien den Anforderungen der \u00d6ffentlichkeit entsprechen.<\/p>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" class=\"button primary is-link is-medium\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n<p>\u00a9Dieser RegAlert wird herausgegeben von RegASK<\/p>","protected":false},"excerpt":{"rendered":"<p>On August 20, 2024, the Food and Drug Administration (FDA) of Thailand issued an important update to the guidelines for electronically submitted modern drug formula registrations, originally established on June 23, 2023. This update specifically revises the standards for labeling and patient information leaflets (PILs) across certain drug categories, aiming to streamline the registration process&#8230;<\/p>","protected":false},"author":22,"featured_media":7514,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,535],"tags":[177,299,474,479,480],"class_list":["post-7504","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-thailand-regulations","tag-labelling","tag-regulatory-intelligence","tag-product-compliance","tag-household-medicine","tag-product-information-leaflet"],"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>Thailand FDA Enhances Drug Labeling Guidelines | RegASK<\/title>\n<meta name=\"description\" content=\"Thailand&#039;s FDA introduces stricter drug labeling &amp; patient information leaflets (PIL) requirements to enhance clarity &amp; streamline processes.\" \/>\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\/thailandische-fda-richtlinien-zur-arzneimittelkennzeichnung\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Thailand FDA Enhances Drug Labeling and PIL Rules: New Testing Requirements for Household Medicines\" \/>\n<meta property=\"og:description\" content=\"Thailand&#039;s FDA introduces stricter drug labeling &amp; patient information leaflets (PIL) requirements to enhance clarity &amp; streamline processes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/thailandische-fda-richtlinien-zur-arzneimittelkennzeichnung\/\" \/>\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=\"2024-08-22T12:14:17+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-08T19:26:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2024\/08\/thailand-fda-enhances-drug-labeling-pil-rules-new-testing-requirements-household-medicines.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Divvya Behal\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta 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