{"id":8270,"date":"2018-06-26T13:28:52","date_gmt":"2018-06-26T13:28:52","guid":{"rendered":"https:\/\/survivornet.ca\/?post_type=news&#038;p=8270\/"},"modified":"2018-06-26T13:28:52","modified_gmt":"2018-06-26T13:28:52","slug":"sante-canada-lacmts-et-linesss-collaborent-a-lharmonisation-des-processus-devaluation-des-medicaments","status":"publish","type":"news","link":"https:\/\/survivornet.ca\/fr\/apprenez\/nouvelles\/sante-canada-lacmts-et-linesss-collaborent-a-lharmonisation-des-processus-devaluation-des-medicaments\/","title":{"rendered":"Sant\u00e9 Canada, l\u2019ACMTS et l\u2019INESSS collaborent \u00e0 l\u2019harmonisation des processus d\u2019\u00e9valuation des m\u00e9dicaments"},"content":{"rendered":"<p><strong>Une nouvelle proc\u00e9dure conjointe vise \u00e0 r\u00e9duire le d\u00e9lai entre l\u2019autorisation de mise en march\u00e9 et les recommandations de remboursement<\/strong><\/p>\n<p>Sant\u00e9 Canada, l\u2019ACMTS et l\u2019Institut national d\u2019excellence en sant\u00e9 et en services sociaux (INESSS) du Qu\u00e9bec redoublent d\u2019efforts pour harmoniser l\u2019\u00e9valuation des m\u00e9dicaments et soutenir l\u2019abordabilit\u00e9, l\u2019accessibilit\u00e9 et l\u2019usage ad\u00e9quat des m\u00e9dicaments d\u2019ordonnance au Canada.<\/p>\n<p>Dans le cadre de l\u2019initiative de Sant\u00e9 Canada visant l\u2019am\u00e9lioration de l\u2019examen r\u00e8glementaire des m\u00e9dicaments et des instruments, les trois organismes sont fiers d\u2019annoncer que les fabricants de m\u00e9dicaments ont d\u00e9sormais la possibilit\u00e9 de participer \u00e0 un processus formel int\u00e9gr\u00e9 et harmonis\u00e9 d\u2019\u00e9valuation de m\u00e9dicament, comprenant les demandes jug\u00e9es recevables de nouveaux m\u00e9dicaments et de nouvelles indications.<\/p>\n<p>Cette annonce d\u00e9finit les \u00e9tapes et le calendrier de cette nouvelle proc\u00e9dure, et d\u00e9crit le processus \u00e0 suivre pour les fabricants qui ont des demandes \u00e0 pr\u00e9senter concernant des m\u00e9dicaments recevables, et qui d\u00e9sirent participer \u00e0 une \u00e9valuation harmonis\u00e9e entre Sant\u00e9 Canada, l\u2019ACMTS (par son Programme commun d\u2019\u00e9valuation des m\u00e9dicaments ou son Programme pancanadien d\u2019\u00e9valuation des anticanc\u00e9reux) et l\u2019INESSS. Elle donne \u00e9galement les grandes lignes des avantages qu\u2019apportent des examens harmonis\u00e9s, dont\u00a0:<\/p>\n<ul class=\"content-list\">\n<li>la r\u00e9duction des d\u00e9lais entre l\u2019octroi de l\u2019avis de conformit\u00e9 de Sant\u00e9 Canda et les recommandations \u00e9mises par l\u2019ACMTS ou l\u2019INESSS sur le remboursement des m\u00e9dicaments par les r\u00e9gimes publics d\u2019assurance-m\u00e9dicaments; et<\/li>\n<li>l\u2019am\u00e9lioration des communications entre les organismes, permettant ainsi de discuter en temps r\u00e9el et de r\u00e9duire les d\u00e9doublements.<\/li>\n<\/ul>\n<p>\u00ab\u00a0Bien que Sant\u00e9 Canada et les organismes d\u2019\u00e9valuation des technologies de la sant\u00e9 comme l\u2019ACMTS et l\u2019INESSS ont des responsabilit\u00e9s distinctes, nous contribuons \u00e0 un objectif commun qui est de s\u2019assurer que tous les Canadiens et Canadiennes aient acc\u00e8s \u00e0 des traitements efficaces qui apportent de la valeur \u00e0 nos syst\u00e8mes de sant\u00e9, dit Heather Logan, vice-pr\u00e9sidente int\u00e9rimaire des \u00e9valuations de m\u00e9dicaments \u00e0 l\u2019ACMTS. Le nouveau processus d\u2019examen harmonis\u00e9 est un excellent exemple de ce que la collaboration peut accomplir lorsqu\u2019il s\u2019agit de combler les lacunes, r\u00e9duire les d\u00e9lais et d\u2019am\u00e9liorer la gestion des m\u00e9dicaments au Canada.\u00a0\u00bb<\/p>\n<p>Pour obtenir les d\u00e9tails complets au sujet de ce nouveau processus, consultez\u00a0<a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/organisation\/transparence\/transparence-ouverture-en-matiere-reglementation\/examens-reglementaire-materiel-medical\/examens-harmonises-sante-canada-organismes-evaluation-technologies-sante.html\">l\u2019avis \u00e0 l\u2019industrie de Sant\u00e9 Canada<\/a>. Au cours des prochains mois, Sant\u00e9 Canada, l\u2019ACMTS et l\u2019INESSS pr\u00e9senteront un webinaire \u00e0 l\u2019intention de toutes les parties int\u00e9ress\u00e9es et offrant des renseignements plus complets \u00e0 ce propos.<\/p>\n<p><strong><em>Le parcours vers un processus harmonis\u00e9 d\u2019\u00e9valuation des m\u00e9dicaments<\/em><\/strong><\/p>\n<p>Depuis un certain temps, les principaux intervenants du Canada ont pris conscience du besoin de mieux harmoniser les processus d\u2019\u00e9valuation de m\u00e9dicaments qui font partie de notre syst\u00e8me robuste d\u2019autorisation des m\u00e9dicaments. Pour r\u00e9pondre \u00e0 ce besoin, Sant\u00e9 Canada a mis en \u0153uvre l\u2019Examen r\u00e8glementaire des m\u00e9dicaments et des instruments dans le but d\u2019atteindre une meilleure collaboration entre les organismes qui travaillent \u00e0 rendre l\u2019environnement r\u00e8glementaire plus sensible aux besoins des syst\u00e8mes de sant\u00e9 canadiens.<\/p>\n<p>L\u2019un des r\u00e9sultats concrets de cette collaboration a \u00e9t\u00e9 annonc\u00e9 en mars\u00a02018 lorsque l\u2019ACMTS a mis en place un important changement op\u00e9rationnel qui permet maintenant au Programme commun d\u2019\u00e9valuation des m\u00e9dicaments d\u2019accepter les demandes d\u2019\u00e9valuation jusqu\u2019\u00e0 6\u00a0mois avant la date pr\u00e9vue de l\u2019\u00e9mission de l\u2019avis de conformit\u00e9 par Sant\u00e9 Canada. Il s\u2019agit d\u2019une \u00e9tape notable vers l\u2019\u00e9limination des d\u00e9lais entre l\u2019autorisation r\u00e8glementaire de Sant\u00e9 Canada et les recommandations de remboursement que l\u2019ACMTS \u00e9met aux r\u00e9gimes d\u2019assurance-m\u00e9dicaments publics.<\/p>\n<p>Pr\u00e9c\u00e9demment, en 2017, un projet pilote du Programme pancanadien d\u2019\u00e9valuation des anticanc\u00e9reux (PPEA) de l\u2019ACMTS et du Bureau du m\u00e9tabolisme, de l\u2019oncologie et des sciences de la reproduction (BMOSR) de Sant\u00e9 Canada a permis d\u2019\u00e9tablir les bases d\u2019un processus harmonis\u00e9 d\u2019\u00e9valuation. Au cours de ce projet, le PPEA et le BMORS ont examin\u00e9 comment un meilleur partage de l\u2019information durant les processus d\u2019\u00e9valuation peut contribuer \u00e0 l\u2019harmonisation des \u00e9valuations de m\u00e9dicaments.<\/p>\n<p><strong><em>Information pertinente<\/em><\/strong><\/p>\n<ul class=\"content-list\">\n<li><a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/organisation\/transparence\/transparence-ouverture-en-matiere-reglementation\/examens-reglementaire-materiel-medical\/examens-harmonises-sante-canada-organismes-evaluation-technologies-sante.html\">Avis \u00e0 l\u2019industrie\u00a0: Harmonisation des examens entre Sant\u00e9 Canada et les organismes d\u2019\u00e9valuation des technologies de la sant\u00e9<\/a><\/li>\n<li><a href=\"https:\/\/www.canada.ca\/fr\/sante-canada\/organisation\/transparence\/transparence-ouverture-en-matiere-reglementation\/examens-reglementaire-materiel-medical.html\">Am\u00e9liorer l\u2019examen r\u00e8glementaire des m\u00e9dicaments et des instruments<\/a><\/li>\n<li><a href=\"https:\/\/cadth.ca\/fr\/nouvelles\/le-programme-commun-devaluation-des-medicaments-de-lacmts-acceptera-les-demandes-dexamen\">Le Programme commun d\u2019\u00e9valuation des m\u00e9dicaments de l\u2019ACMTS acceptera les demandes d\u2019examen jusqu\u2019\u00e0 six mois avant la d\u00e9livrance de l\u2019avis de conformit\u00e9<\/a>(mars\u00a02018)<\/li>\n<li><a href=\"https:\/\/www.inesss.qc.ca\/fileadmin\/doc\/INESSS\/Inscription_medicaments\/Avis_fabricants\/20180404_Avis_fabricants_pre-AC_et_biosimilaires.pdf\">Nouvelles informations concernant l\u2019\u00e9valuation des m\u00e9dicaments aux fins d\u2019inscription<\/a>\u00a0(avril\u00a02018)<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Une nouvelle proc\u00e9dure conjointe vise \u00e0 r\u00e9duire le d\u00e9lai entre l\u2019autorisation de mise en march\u00e9 et les recommandations de remboursement Sant\u00e9 Canada, l\u2019ACMTS et l\u2019Institut national d\u2019excellence en sant\u00e9 et en services<\/p>\n","protected":false},"author":2,"featured_media":8267,"comment_status":"closed","ping_status":"closed","template":"","tags":[],"news-category":[],"class_list":["post-8270","news","type-news","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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