{"id":5486,"date":"2023-11-21T10:19:55","date_gmt":"2023-11-21T15:19:55","guid":{"rendered":"https:\/\/spharm-inc.com\/wp2021\/?p=5486"},"modified":"2025-03-28T16:40:33","modified_gmt":"2025-03-28T20:40:33","slug":"quel-est-le-delai-pour-obtenir-lapprobation-dun-produit-des-sciences-de-la-vie-au-canada","status":"publish","type":"post","link":"https:\/\/spharm-inc.com\/fr\/quel-est-le-delai-pour-obtenir-lapprobation-dun-produit-des-sciences-de-la-vie-au-canada\/","title":{"rendered":"Quel est le d\u00e9lai pour obtenir l\u2019approbation d\u2019un produit des sciences de la vie au Canada?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"5486\" class=\"elementor elementor-5486\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3032b61d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3032b61d\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;_id&quot;:&quot;a36f0df&quot;,&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-63e9c7f3\" data-id=\"63e9c7f3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3f619b10 elementor-widget elementor-widget-text-editor\" data-id=\"3f619b10\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h1 style=\"text-align: center;\">Quel est le d\u00e9lai pour obtenir l\u2019approbation d\u2019un produit des sciences de la vie au Canada?<\/h1><p><span style=\"color: #9b5200;\"><strong>QUELLES SONT LES D\u00c9LAIS DE SANT\u00c9 CANADA AFIN D\u2019OBTENIR L\u2019AUTORISATION DE VENDRE UN M\u00c9DICAMENT SUR LE MARCH\u00c9 CANADIEN?<\/strong><\/span><\/p><p>Le d\u00e9lai de r\u00e9vision canadien pour une pr\u00e9sentation de drogue nouvelle (PDN) est concurrentiel. Une r\u00e9vision standard consiste en une validation eCTD d\u2019une dur\u00e9e maximale de 10 jours, suivie d\u2019une pr\u00e9s\u00e9lection administrative de 45 jours au cours de laquelle le contenu est v\u00e9rifi\u00e9 et il est valid\u00e9 qu\u2019aucune information cl\u00e9 n\u2019est manquante. Apr\u00e8s la p\u00e9riode de pr\u00e9s\u00e9lection, un examen scientifique de 300 jours des donn\u00e9es qualit\u00e9, non cliniques et cliniques, s\u2019applique. Donc, un total de 355 jours de r\u00e9vision s\u2019applique, avant qu\u2019un promoteur obtienne une d\u00e9cision finale.<\/p><p>Si la PDN est admissible \u00e0 un examen acc\u00e9l\u00e9r\u00e9 dans le cadre d\u2019une \u00e9valuation prioritaire ou d\u2019un avis de conformit\u00e9 avec condition, les d\u00e9lais d\u2019examen sont plus courts.<br \/><br \/><\/p><hr \/><h3><br \/>Pour toute question sur le processus canadien d\u2019examen et de r\u00e9glementation des m\u00e9dicaments qui n\u2019est pas couverte dans cette section, n\u2019h\u00e9sitez pas \u00e0 <a style=\"color: #9b5200;\" href=\"https:\/\/spharm-inc.com\/fr\/contactez-nous\/\">communiquer directement avec nous<\/a>.<\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Quel est le d\u00e9lai pour obtenir l\u2019approbation d\u2019un produit des sciences de la vie au Canada? QUELLES SONT LES D\u00c9LAIS DE SANT\u00c9 CANADA AFIN D\u2019OBTENIR L\u2019AUTORISATION DE VENDRE UN M\u00c9DICAMENT SUR LE MARCH\u00c9 CANADIEN? Le d\u00e9lai de r\u00e9vision canadien pour une pr\u00e9sentation de drogue nouvelle (PDN) est concurrentiel. Une r\u00e9vision standard consiste en une validation [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":6448,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[],"tags":[],"class_list":["post-5486","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quel d\u00e9lai d&#039;approbation pour produits sant\u00e9 au Canada ?<\/title>\n<meta name=\"description\" content=\"Informez-vous sur les d\u00e9lais typiques et \u00e9tapes cl\u00e9s pour l&#039;approbation de produits en sciences de la vie par Sant\u00e9 Canada.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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