{"id":7909,"date":"2024-12-18T18:51:47","date_gmt":"2024-12-18T10:51:47","guid":{"rendered":"https:\/\/regask.com\/?p=7909"},"modified":"2024-12-18T18:51:47","modified_gmt":"2024-12-18T10:51:47","slug":"guide-dapprobation-des-medicaments-de-la-paraguay-dinavisa","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/paraguay-dinavisa-drug-approval-guideline\/","title":{"rendered":"DINAVISA (Paraguay) approuve une nouvelle directive pour la bonne \u00e9\u2026"},"content":{"rendered":"<p>Le 2 d\u00e9cembre 2024, le <a href=\"https:\/\/regask.com\/fr\/reglementation-des-aliments-sans-lactose-au-paraguay\/\">Direction nationale de la surveillance sanitaire<\/a> (DINAVISA) a introduit le <strong>\u00ab Guide des bonnes pratiques d\u2019\u00e9valuation pour l\u2019enregistrement des m\u00e9dicaments. \u00bb<\/strong> Cette ligne directrice repr\u00e9sente une mise \u00e0 jour majeure du cadre r\u00e9glementaire, ax\u00e9e sur la garantie de la qualit\u00e9, de la s\u00e9curit\u00e9 et de l\u2019efficacit\u00e9 des produits pharmaceutiques gr\u00e2ce \u00e0 des processus d\u2019\u00e9valuation clairs et transparents.<\/p>\n<p>Ce guide vise \u00e0 aligner les proc\u00e9dures de DINAVISA sur les normes internationales, favorisant ainsi l&#039;harmonisation avec les normes r\u00e9glementaires mondiales. Il s&#039;applique \u00e0 tous les produits pharmaceutiques destin\u00e9s \u00e0 l&#039;usage humain, notamment les m\u00e9dicaments, les produits biologiques, les produits chimiques, les r\u00e9actifs, les dispositifs m\u00e9dicaux et les produits d&#039;hygi\u00e8ne personnelle class\u00e9s comme cosm\u00e9tiques ou d\u00e9sinfectants.<\/p>\n<p>Les principaux points saillants de la ligne directrice comprennent :<\/p>\n<ul>\n<li>Adh\u00e9sion \u00e0 <strong>normes internationales<\/strong> et les meilleures pratiques en mati\u00e8re d\u2019\u00e9valuation des m\u00e9dicaments.<\/li>\n<li>Exigences de conformit\u00e9 d\u00e9taill\u00e9es pour chaque \u00e9tape du d\u00e9veloppement du produit, y compris les \u00e9tudes pr\u00e9cliniques, l&#039;autorisation des essais cliniques, les modifications post-commercialisation et les processus de r\u00e9enregistrement.<\/li>\n<li>L&#039;accent est mis sur un <strong>approche multidisciplinaire<\/strong> qui int\u00e8gre les \u00e9valuations non cliniques, cliniques, de biocompatibilit\u00e9, de processus de fabrication et de gestion des risques.<\/li>\n<li>M\u00e9canismes permettant de tirer parti des \u00e9valuations men\u00e9es par des organismes reconnus <strong>autorit\u00e9s r\u00e9glementaires internationales<\/strong> pour acc\u00e9l\u00e9rer les examens tout en maintenant des normes strictes de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9.<\/li>\n<li>L&#039;accent mis sur le parrainage <strong>d\u00e9veloppement professionnel continu<\/strong> et la pens\u00e9e critique parmi les \u00e9valuateurs pour garantir des d\u00e9cisions fond\u00e9es sur des preuves et fond\u00e9es sur les connaissances scientifiques actuelles.<\/li>\n<\/ul>\n<p>Le nouveau guide constitue une \u00e9tape importante vers la modernisation et la rationalisation du processus d\u2019autorisation de mise sur le march\u00e9 des produits pharmaceutiques, garantissant que les d\u00e9cisions r\u00e9glementaires sont coh\u00e9rentes, transparentes et align\u00e9es sur les pratiques mondiales.<\/p>\n<p>Pour plus de d\u00e9tails ou demandes de renseignements, veuillez nous contacter.<\/p>","protected":false},"excerpt":{"rendered":"<p>Le 2 d\u00e9cembre 2024, la Direction nationale de la surveillance sanitaire (DINAVISA) a publi\u00e9 le \u201c\u00a0Guide des bonnes pratiques d&#039;\u00e9valuation pour l&#039;enregistrement des m\u00e9dicaments\u00a0\u201d. Ce guide constitue une mise \u00e0 jour majeure du cadre r\u00e9glementaire, visant \u00e0 garantir la qualit\u00e9, la s\u00e9curit\u00e9 et l&#039;efficacit\u00e9 des produits pharmaceutiques gr\u00e2ce \u00e0 des processus d&#039;\u00e9valuation clairs et transparents. Il vise \u00e0 harmoniser\u2026<\/p>","protected":false},"author":43,"featured_media":7926,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,566],"tags":[496,609],"class_list":["post-7909","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-paraguay-regulation","tag-market-authorization-regs","tag-guideline"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Paraguay Issues New Guideline for Drug Approvals | RegASK<\/title>\n<meta name=\"description\" content=\"Paraguay\u2019s DINAVISA releases a new guideline for drug approvals, aligning with global standards for safety and efficacy. 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