{"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":"directives-de-la-fda-sur-letiquetage-des-medicaments-en-thailande","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/thailand-fda-drug-labeling-guidelines\/","title":{"rendered":"La FDA tha\u00eflandaise am\u00e9liore l\u2019\u00e9tiquetage des m\u00e9dicaments et les r\u00e8gles relatives aux PIL : nouveau \u2026"},"content":{"rendered":"<p>Le 20 ao\u00fbt 2024, la Food and Drug Administration (FDA) de Tha\u00eflande a publi\u00e9 une importante mise \u00e0 jour des directives relatives aux enregistrements de formules de m\u00e9dicaments modernes soumis par voie \u00e9lectronique, initialement \u00e9tablies le 23 juin 2023. Cette mise \u00e0 jour r\u00e9vise sp\u00e9cifiquement les normes d&#039;\u00e9tiquetage et les notices d&#039;information destin\u00e9es aux patients (PIL) pour certaines cat\u00e9gories de m\u00e9dicaments, dans le but de rationaliser le processus d&#039;enregistrement et de garantir que les informations destin\u00e9es aux consommateurs sont claires, accessibles et conformes aux normes internationales. Cette r\u00e9vision devrait renforcer la comp\u00e9titivit\u00e9 de l&#039;industrie pharmaceutique tha\u00eflandaise et am\u00e9liorer l&#039;acc\u00e8s du public aux m\u00e9dicaments essentiels.<\/p>\n<p>Les lignes directrices mises \u00e0 jour visent \u00e0 affiner l\u2019\u00e9tiquetage et les notices d\u2019information destin\u00e9es aux patients pour les m\u00e9dicaments modernes en :<\/p>\n<ul>\n<li><strong>Tests utilisateurs publics pour les PIL<\/strong>:La mise \u00e0 jour impose que pour les m\u00e9dicaments domestiques, ainsi que pour les m\u00e9dicaments non class\u00e9s comme dangereux ou soumis \u00e0 un contr\u00f4le sp\u00e9cial, y compris ceux r\u00e9cemment d\u00e9class\u00e9s de ces classifications, les notices d&#039;information destin\u00e9es aux patients doivent \u00eatre soumises \u00e0 des tests publics aupr\u00e8s des utilisateurs.<\/li>\n<li><strong>Sp\u00e9cifications de test<\/strong>:Les tests utilisateurs doivent \u00eatre effectu\u00e9s sur des supports qui refl\u00e8tent exactement le produit final en termes de taille, de qualit\u00e9 du papier, de couleur et de style de police. Un rapport de test complet doit \u00eatre r\u00e9dig\u00e9 et soumis pour les PIL.<\/li>\n<\/ul>\n<p>Cet ajustement vise \u00e0 garantir que les informations fournies sur les \u00e9tiquettes et les notices d&#039;information soient claires, facilement comprises et v\u00e9rifi\u00e9es par le public, favorisant ainsi les soins personnels et la pr\u00e9vention des maladies en phase avec les besoins soci\u00e9taux de la Tha\u00eflande.<\/p>\n<p>Cette mise \u00e0 jour marque un changement important pour les m\u00e9dicaments \u00e0 usage domestique et les autres m\u00e9dicaments non dangereux ou non soumis \u00e0 un contr\u00f4le sp\u00e9cial, en particulier ceux r\u00e9cemment reclass\u00e9s. Les entreprises pharmaceutiques sont d\u00e9sormais tenues de proc\u00e9der \u00e0 des tests publics pour les PIL, afin de s&#039;assurer que ces documents d&#039;information r\u00e9pondent aux normes de compr\u00e9hension du public.<\/p>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" class=\"button primary is-link is-medium\" rel=\"noopener\" >\n\t\t<span>Pour en savoir plus<\/span>\n\t<\/a>\n\n<p>\u00a9Cette RegAlert est \u00e9mise par 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 v27.8 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Thailand FDA Enhances Drug Labeling Guidelines | 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