{"id":9716,"date":"2026-03-25T17:04:10","date_gmt":"2026-03-25T09:04:10","guid":{"rendered":"https:\/\/regask.com\/?p=9716"},"modified":"2026-03-25T17:04:56","modified_gmt":"2026-03-25T09:04:56","slug":"mhra-et-nice-lancent-un-processus-dautorisation-et-devaluation-des-technologies-de-la-sante-ets-harmonise-afin-daccelerer-lacces-aux-medicaments-en-angleterre","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/mhra-and-nice-launch-aligned-licensing-and-hta-process-to-accelerate-access-to-medicines-in-england\/","title":{"rendered":"La MHRA et le NICE lancent un processus d&#039;autorisation et d&#039;\u00e9valuation des technologies de la sant\u00e9 harmonis\u00e9\u2026"},"content":{"rendered":"<p>Sur <strong>17 mars 2026<\/strong>, le <strong>Agence de r\u00e9glementation des m\u00e9dicaments et des produits de sant\u00e9 (MHRA)<\/strong> et le <strong>Institut national pour l&#039;excellence en sant\u00e9 et en soins (NICE)<\/strong> a annonc\u00e9 une nouvelle <strong>processus conjoint<\/strong> qui s&#039;aligne <strong>autorisation r\u00e9glementaire<\/strong> avec <strong>\u00e9valuation des technologies de la sant\u00e9 (ETS)<\/strong> pour les produits pharmaceutiques en Angleterre. Lancement le <strong>1er avril 2026<\/strong>, cette approche est con\u00e7ue pour <strong>acc\u00e9l\u00e9rer l&#039;acc\u00e8s des patients aux nouveaux m\u00e9dicaments de trois \u00e0 six mois<\/strong> par le biais de voies d&#039;examen synchronis\u00e9es.<\/p>\n<div class=\"row\"  id=\"row-113526849\">\n\n\t<div id=\"col-96541960\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-277944635\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-277944635 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-2049918935\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2049918935 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le nouveau processus introduit un <strong>mod\u00e8le d&#039;examen parall\u00e8le<\/strong>, permettant <strong>d\u00e9cisions d&#039;autorisation de la MHRA<\/strong> et <strong>\u00c9valuations des technologies de la sant\u00e9 par le NICE<\/strong> Cette proc\u00e9dure devrait \u00eatre mise en \u0153uvre simultan\u00e9ment pour les nouveaux m\u00e9dicaments. Cette approche coordonn\u00e9e devrait r\u00e9duire les d\u00e9lais entre l&#039;approbation r\u00e9glementaire et les d\u00e9cisions de remboursement.<\/p>\n<p>Un \u00e9l\u00e9ment cl\u00e9 de cette initiative est le <strong>Service int\u00e9gr\u00e9 de conseil scientifique<\/strong>, qui fournit un <strong>point d&#039;entr\u00e9e unique<\/strong> pour que les entreprises pharmaceutiques re\u00e7oivent <strong>orientation coordonn\u00e9e<\/strong> concernant les exigences r\u00e9glementaires et la production de donn\u00e9es probantes. L\u2019objectif est d\u2019assurer la coh\u00e9rence entre les strat\u00e9gies de d\u00e9veloppement clinique et les attentes en mati\u00e8re de r\u00e9glementation et d\u2019\u00e9valuation de la valeur.<\/p>\n<p>Le processus s&#039;applique sp\u00e9cifiquement \u00e0 <strong>des produits pharmaceutiques cherchant \u00e0 entrer sur le march\u00e9 anglais<\/strong>, alors que <strong>Les dispositifs m\u00e9dicaux ne sont pas inclus.<\/strong> dans ce d\u00e9ploiement initial. La participation commencera sous un <strong>phase d&#039;acc\u00e8s anticip\u00e9<\/strong>, avec le <strong>Les premiers r\u00e9sultats sont attendus \u00e0 partir de juin 2026.<\/strong> pour les produits actuellement en d\u00e9veloppement ou en cours d&#039;\u00e9valuation.<\/p>\n<p>Les parties prenantes peuvent acc\u00e9der \u00e0 de plus amples informations via un <strong>Webinaire d\u00e9di\u00e9 pr\u00e9vu le 25 mars 2026<\/strong>, apportant des pr\u00e9cisions suppl\u00e9mentaires sur la mise en \u0153uvre et les consid\u00e9rations op\u00e9rationnelles.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-96541960 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-969157263\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Date d&#039;entr\u00e9e en vigueur<\/h2>\n\t<div id=\"gap-1407965739\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1407965739 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le processus MHRA-NICE harmonis\u00e9 sera mis en \u0153uvre \u00e0 partir de <strong>1er avril 2026<\/strong>, avec des r\u00e9sultats initiaux attendus de <strong>Juin 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-969157263 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-471815116\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-706089803\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-706089803 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour am\u00e9liore <strong>efficacit\u00e9 r\u00e9glementaire<\/strong> en harmonisant les proc\u00e9dures d&#039;autorisation et de remboursement, en r\u00e9duisant les doublons et en am\u00e9liorant la coordination entre les autorit\u00e9s. Il soutient <strong>des d\u00e9lais de prise de d\u00e9cision plus rapides<\/strong> et promeut <strong>alignement des preuves<\/strong> respectant les exigences r\u00e9glementaires et d&#039;\u00e9valuation des technologies de la sant\u00e9, facilitant en fin de compte la r\u00e9alisation des objectifs. <strong>acc\u00e8s plus rapide aux patients<\/strong> tout en maintenant des normes d&#039;\u00e9valuation rigoureuses.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-471815116 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1424638192\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Qui est concern\u00e9 ?<\/h2>\n\t<div id=\"gap-1183722085\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1183722085 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette \u00e9volution est pertinente pour <strong>Affaires r\u00e9glementaires<\/strong>, <strong>R&amp;D<\/strong>, <strong>Acc\u00e8s au march\u00e9<\/strong>, et <strong>\u00e9quipes d&#039;\u00e9conomie de la sant\u00e9<\/strong> au sein des entreprises pharmaceutiques en d\u00e9veloppement <strong>nouveaux m\u00e9dicaments pour le march\u00e9 britannique<\/strong>, en particulier celles qui pr\u00e9voient de soumettre des demandes de permis de construire en Angleterre dans le cadre de r\u00e9glementations et de syst\u00e8mes de remboursement en constante \u00e9volution.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1424638192 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2017467537\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-2068755358\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2068755358 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les organisations devraient <strong>\u00e9valuer les pipelines de produits actuels<\/strong> pour d\u00e9terminer l&#039;admissibilit\u00e9 au processus align\u00e9 et envisager d&#039;y participer <strong>Webinaire du 25 mars<\/strong> comprendre les exigences op\u00e9rationnelles. Interne <strong>strat\u00e9gies de soumission, plans de production de preuves et processus de pr\u00e9paration des dossiers<\/strong> devrait \u00eatre r\u00e9vis\u00e9 et mis \u00e0 jour pour \u00eatre conforme \u00e0 <strong>orientations int\u00e9gr\u00e9es MHRA-NICE<\/strong>.<\/p>\n<p>\u00c0 mesure que les voies r\u00e9glementaires et d&#039;acc\u00e8s au march\u00e9 deviennent de plus en plus interconnect\u00e9es, l&#039;alignement des strat\u00e9gies dans ces deux domaines est essentiel pour obtenir des approbations et des remboursements en temps opportun.<\/p>\n<p><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentique, qui permet aux organisations internationales des secteurs fortement r\u00e9glement\u00e9s, tels que les produits de consommation et les sciences de la vie, d&#039;anticiper les complexit\u00e9s r\u00e9glementaires. En combinant une IA agentique avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes, <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <a href=\"https:\/\/regask.com\/fr\/produit\/\">En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9server une d\u00e9mo<\/a> maintenant.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2017467537 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1812026475\">\n\n\t<div id=\"col-100329332\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQ<\/h3>\n\t<div id=\"gap-445984164\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-445984164 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>En quoi consiste le processus align\u00e9 MHRA-NICE\u00a0?<\/h4>\n\t<div id=\"gap-357445248\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-357445248 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>C&#039;est un <strong>Voie conjointe de r\u00e9glementation et d&#039;\u00e9valuation des technologies de la sant\u00e9<\/strong> qui permet <strong>Examen parall\u00e8le des licences et des \u00e9valuations des technologies de la sant\u00e9<\/strong> pour les nouveaux m\u00e9dicaments en Angleterre.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-100329332 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-971790796\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Quand le nouveau processus entrera-t-il en vigueur\u00a0?<\/h4>\n\t<div id=\"gap-1816131684\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1816131684 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le processus sera mis en \u0153uvre \u00e0 partir de <strong>1er avril 2026<\/strong>, avec les premiers r\u00e9sultats attendus de <strong>Juin 2026<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-971790796 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-774333295\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Qu\u2019est-ce que le service de conseil scientifique int\u00e9gr\u00e9\u00a0?<\/h4>\n\t<div id=\"gap-1837997401\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1837997401 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>C&#039;est un <strong>point d&#039;entr\u00e9e unique<\/strong> qui fournit <strong>orientations r\u00e9glementaires et factuelles coordonn\u00e9es<\/strong> pour appuyer les soumissions harmonis\u00e9es \u00e0 la MHRA et au NICE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-774333295 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-193285846\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Comment le programme RegASK peut-il soutenir les entreprises dans le cadre de ce nouveau processus\u00a0?<\/h4>\n\t<div id=\"gap-1879593616\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1879593616 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\">RegASK <\/a>aide les organisations <strong>Suivre l&#039;\u00e9volution de la r\u00e9glementation et des \u00e9valuations des technologies de la sant\u00e9<\/strong>, aligner <strong>strat\u00e9gies de preuve et de soumission<\/strong>, et rationaliser <strong>flux de travail interfonctionnels<\/strong>, permettant une navigation plus efficace dans les circuits d&#039;approbation synchronis\u00e9s.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-193285846 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Le 17 mars 2026, la Medicines and Healthcare products Regulatory Agency (MHRA) et le National Institute for Health and Care Excellence (NICE) ont annonc\u00e9 une nouvelle proc\u00e9dure conjointe visant \u00e0 harmoniser l&#039;autorisation de mise sur le march\u00e9 des m\u00e9dicaments en Angleterre avec l&#039;\u00e9valuation des technologies de la sant\u00e9 (ETS). Mise en \u0153uvre le 1er avril 2026, cette approche a pour objectif d&#039;acc\u00e9l\u00e9rer l&#039;acc\u00e8s des patients aux nouveaux traitements\u2026<\/p>","protected":false},"author":32,"featured_media":9717,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,39,35],"tags":[],"class_list":["post-9716","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-medical-devices-insights","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MHRA and NICE Launch Aligned Process for Medicines<\/title>\n<meta name=\"description\" content=\"Discover how the MHRA and NICE aligned licensing and HTA process will transform patient access to new medicines in England.\" \/>\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\/fr\/mhra-et-nice-lancent-un-processus-dautorisation-et-devaluation-des-technologies-de-la-sante-ets-harmonise-afin-daccelerer-lacces-aux-medicaments-en-angleterre\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MHRA and NICE Launch Aligned Licensing and HTA Process to Accelerate Access to Medicines in England\" \/>\n<meta property=\"og:description\" content=\"Discover how the MHRA and NICE aligned licensing and HTA process will transform patient access to new medicines in England.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/mhra-et-nice-lancent-un-processus-dautorisation-et-devaluation-des-technologies-de-la-sante-ets-harmonise-afin-daccelerer-lacces-aux-medicaments-en-angleterre\/\" \/>\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=\"2026-03-25T09:04:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-25T09:04:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/mhra-nice-launch-aligned-licensing-hta-process-accelerate-access-medicines-england.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Hannah Nordin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Hannah Nordin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/mhra-and-nice-launch-aligned-licensing-and-hta-process-to-accelerate-access-to-medicines-in-england\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mhra-and-nice-launch-aligned-licensing-and-hta-process-to-accelerate-access-to-medicines-in-england\\\/\"},\"author\":{\"name\":\"Hannah 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