{"id":9350,"date":"2026-01-06T14:35:16","date_gmt":"2026-01-06T06:35:16","guid":{"rendered":"https:\/\/regask.com\/?p=9350"},"modified":"2026-01-06T14:35:16","modified_gmt":"2026-01-06T06:35:16","slug":"lema-met-a-jour-ses-recommandations-sur-les-protocoles-de-gestion-des-changements-apres-autorisation-de-mise-sur-le-marche-afin-de-renforcer-la-conformite-au-cycle-de-vie-des-medicaments","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/ema-updates-guidance-on-post-approval-change-management-protocols-to-strengthen-medicinal-product-lifecycle-compliance\/","title":{"rendered":"L\u2019EMA met \u00e0 jour ses recommandations sur la gestion des changements apr\u00e8s approbation\u2026"},"content":{"rendered":"<p>Sur <strong>11 d\u00e9cembre 2025,<\/strong> le <a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\"><strong>Agence europ\u00e9enne des m\u00e9dicaments (EMA)<\/strong><\/a> publi\u00e9 <strong>Lignes directrices r\u00e9vis\u00e9es sur les protocoles de gestion des changements post-approbation (PACMP),<\/strong> Mise \u00e0 jour du cadre de gestion du cycle de vie des m\u00e9dicaments \u00e0 usage humain dans l&#039;ensemble de l&#039;Union europ\u00e9enne. Ce guide int\u00e8gre l&#039;exp\u00e9rience r\u00e9glementaire acquise depuis 2012 et s&#039;aligne sur les normes en vigueur. <strong>R\u00e8glement et lignes directrices de l&#039;UE mis \u00e0 jour concernant les variations,<\/strong> qui prennent effet le <strong>15 janvier 2026.<\/strong> Elle s&#039;applique \u00e0 tous les m\u00e9dicaments \u00e0 usage humain et vise \u00e0 permettre un traitement r\u00e9glementaire plus rapide et plus pr\u00e9visible des changements de qualit\u00e9 admissibles.<\/p>\n<div class=\"row\"  id=\"row-1728099701\">\n\n\t<div id=\"col-1730565296\" 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-2110779706\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2110779706 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Explication de la directive mise \u00e0 jour<\/h2>\n\t<div id=\"gap-1073372140\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1073372140 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives r\u00e9vis\u00e9es pr\u00e9cisent que <strong>Les PACMP peuvent \u00eatre soumis<\/strong> dans le cadre d&#039;une premi\u00e8re <strong><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/marketing-authorisation\">autorisation de mise sur le march\u00e9<\/a> application (MAA),<\/strong> comme un <strong>extension de ligne,<\/strong> ou par l&#039;interm\u00e9diaire d&#039;un <strong>variante de type II<\/strong>, permettant aux entreprises de pr\u00e9d\u00e9finir des strat\u00e9gies pour les futures \u00e9volutions de la qualit\u00e9. Il explique que les changements mis en \u0153uvre dans le cadre d&#039;un PACMP approuv\u00e9 sont g\u00e9n\u00e9ralement trait\u00e9s \u00e0 l&#039;aide de <strong>les types de variations \u00e0 faible risque, tels que les types IA, IAIN ou IB,<\/strong> plut\u00f4t que des proc\u00e9dures plus complexes utilis\u00e9es dans les voies de variation standard.<\/p>\n<p>Les directives confirment \u00e9galement que <strong>Les PACMP \u00e0 usage multiple sont autoris\u00e9s.,<\/strong> \u00e0 condition que les conditions pr\u00e9d\u00e9finies et les crit\u00e8res d&#039;acceptation restent inchang\u00e9s au fil du temps. Toutefois, il est clairement indiqu\u00e9 que <strong>Les PACMP ne peuvent pas \u00eatre utilis\u00e9s<\/strong> pour les changements qui n\u00e9cessitent des soins cliniques ou non cliniques <strong>\u00e9valuation des donn\u00e9es<\/strong> ou pour des changements qui en r\u00e9sultent eux-m\u00eames<strong> dans une ligne d&#039;extension.\u00a0<\/strong><\/p>\n<p>Afin de favoriser la transparence et le contr\u00f4le du cycle de vie, l&#039;EMA exige que <strong>Tous les PACMP doivent \u00eatre r\u00e9pertori\u00e9s dans le module 3.2.R du dossier.,<\/strong> garantir une documentation claire des strat\u00e9gies de changement approuv\u00e9es. De plus, la version r\u00e9vis\u00e9e <strong>Les lignes directrices de l&#039;UE relatives aux modifications ne s&#039;appliquent qu&#039;aux modifications mises en \u0153uvre soumises \u00e0 compter du 15 janvier 2026.,<\/strong> \u00c9tablir un calendrier de transition clair pour les \u00e9quipes r\u00e9glementaires.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1730565296 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1692610017\" 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 limite de retour d&#039;information<\/h2>\n\t<div id=\"gap-321805708\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-321805708 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>Aucun d\u00e9lai pour les commentaires ou les consultations n&#039;a \u00e9t\u00e9 sp\u00e9cifi\u00e9.<\/strong> pour cette mise \u00e0 jour des directives.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1692610017 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-480852109\" 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-1867512355\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1867512355 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour offre une plus grande autonomie <strong>clart\u00e9 r\u00e9glementaire<\/strong> autour de l&#039;utilisation des PACMP, supporte <strong>alignement num\u00e9rique<\/strong> avec des cadres de variation de l&#039;UE mis \u00e0 jour et des am\u00e9liorations <strong>efficacit\u00e9<\/strong> En permettant aux modifications de qualit\u00e9 \u00e0 faible risque de suivre des processus pr\u00e9visibles, et en limitant leur port\u00e9e aux modifications ne n\u00e9cessitant aucune \u00e9valuation clinique ou non clinique, ces lignes directrices pr\u00e9servent la rigueur r\u00e9glementaire tout en minimisant les charges administratives inutiles li\u00e9es \u00e0 la gestion du cycle de vie des produits.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-480852109 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-128479257\" 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>\u00c0 qui s&#039;adresse cette mise \u00e0 jour\u00a0?<\/h2>\n\t<div id=\"gap-1232355634\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1232355634 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ses conseils sont pertinents pour <strong>Affaires r\u00e9glementaires, assurance qualit\u00e9, CMC,<\/strong> et <strong>Op\u00e9rations r\u00e9glementaires<\/strong> \u00c9quipes charg\u00e9es de la gestion des modifications post-approbation, de la tenue des dossiers et de la planification du cycle de vie des m\u00e9dicaments \u00e0 usage humain au sein de l&#039;UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-128479257 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1394753932\" 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-1073816307\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1073816307 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les organisations devraient examiner les mesures existantes et planifi\u00e9es. <strong>PACMP<\/strong> afin de confirmer la conformit\u00e9 avec les orientations r\u00e9vis\u00e9es de l&#039;EMA et la mise \u00e0 jour <strong>R\u00e8glement relatif aux variations de l&#039;UE.<\/strong> Les \u00e9quipes r\u00e9glementaires doivent veiller \u00e0 ce que les listes PACMP soient tenues \u00e0 jour avec pr\u00e9cision dans <strong>Module 3.2.R<\/strong> et coordonner les diff\u00e9rentes fonctions afin de pr\u00e9parer la mise en \u0153uvre des variantes soumises par <strong>15 janvier 2026<\/strong> en avant.<\/p>\n<p>Alors que les \u00e9quipes r\u00e9glementaires \u00e9valuent l\u2019admissibilit\u00e9 au PACMP, les voies de variation et la pr\u00e9paration des dossiers dans le cadre r\u00e9vis\u00e9, <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> peut prendre en charge la surveillance continue et la mise en \u0153uvre structur\u00e9e.<\/p>\n<p><strong><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 agentielle<\/strong> qui permet aux organisations internationales op\u00e9rant dans des secteurs fortement r\u00e9glement\u00e9s, notamment les produits de consommation et les sciences de la vie, de s&#039;orienter de mani\u00e8re proactive dans des environnements r\u00e9glementaires complexes. En combinant des technologies de pointe <strong>IA agentique<\/strong> avec des experts impliqu\u00e9s, <a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> Elle fournit des informations pr\u00e9dictives exploitables en temps opportun 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 157 pays. <a href=\"https:\/\/regask.com\/fr\/produit\/\">En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9servez une d\u00e9mo maintenant.\u00a0<\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1394753932 > .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-126759526\">\n\n\t<div id=\"col-3679976\" 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-959892681\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-959892681 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Qu\u2019est-ce qu\u2019un protocole de gestion des changements post-approbation (PACMP)\u00a0?<\/h4>\n\t<div id=\"gap-1518376771\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1518376771 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>UN <strong>PACMP<\/strong> est une strat\u00e9gie r\u00e9glementaire structur\u00e9e et pr\u00e9-approuv\u00e9e qui d\u00e9finit comment des modifications sp\u00e9cifiques de la qualit\u00e9 d&#039;un m\u00e9dicament peuvent \u00eatre mises en \u0153uvre au cours de son cycle de vie en utilisant des conditions et des crit\u00e8res d&#039;acceptation convenus.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-3679976 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2062615980\" 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 les lignes directrices r\u00e9vis\u00e9es de l&#039;EMA concernant le PACMP entreront-elles en vigueur\u00a0?<\/h4>\n\t<div id=\"gap-1915515731\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1915515731 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives r\u00e9vis\u00e9es s&#039;appliquent conform\u00e9ment aux <strong>R\u00e8glement et lignes directrices de l&#039;UE relatifs aux variations, applicables \u00e0 compter du 15 janvier 2026<\/strong>, pour la mise en \u0153uvre des modifications soumises \u00e0 compter de cette date.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2062615980 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-87658141\" 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>Quelles modifications sont exclues des PACMP selon les directives mises \u00e0 jour\u00a0?<\/h4>\n\t<div id=\"gap-985283000\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-985283000 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>PACMP <strong>ne peut pas \u00eatre utilis\u00e9 pour des modifications n\u00e9cessitant une \u00e9valuation des donn\u00e9es cliniques ou non cliniques<\/strong> ou pour des changements qui entra\u00eenent un <strong>ligne d&#039;extension.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-87658141 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-278236152\" 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 RegASK peut-il aider les \u00e9quipes \u00e0 g\u00e9rer les mises \u00e0 jour r\u00e9glementaires li\u00e9es au PACMP\u00a0?<\/h4>\n\t<div id=\"gap-245230885\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-245230885 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/fr\/\">RegASK<\/a> aide les \u00e9quipes r\u00e9glementaires et qualit\u00e9 \u00e0 suivre les mises \u00e0 jour des directives de l&#039;EMA, \u00e0 \u00e9valuer l&#039;\u00e9ligibilit\u00e9 au PACMP et \u00e0 harmoniser les flux de travail des dossiers et des variations gr\u00e2ce \u00e0 une intelligence r\u00e9glementaire pilot\u00e9e par l&#039;IA et \u00e0 des processus de conformit\u00e9 automatis\u00e9s.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-278236152 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 11 December 2025, the European Medicines Agency (EMA) published revised guidance on Post-Approval Change Management Protocols (PACMPs), updating the framework for lifecycle management of human medicinal products across the European Union. The guidance incorporates regulatory experience gained since 2012 and aligns with the updated EU Variations Regulation and Guidelines, which take effect on 15&#8230;<\/p>","protected":false},"author":41,"featured_media":9367,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33,35],"tags":[],"class_list":["post-9350","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EMA Updates Guidance on Post-Approval Change Management<\/title>\n<meta name=\"description\" content=\"Explore the EMA updates on Post-Approval Change Management Protocols to enhance compliance in medicinal product 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