{"id":9534,"date":"2026-02-24T22:52:46","date_gmt":"2026-02-24T14:52:46","guid":{"rendered":"https:\/\/regask.com\/?p=9534"},"modified":"2026-02-25T16:46:25","modified_gmt":"2026-02-25T08:46:25","slug":"lema-publie-des-lignes-directrices-finales-sur-la-gestion-des-risques-lies-aux-impuretes-elementaires-dans-les-medicaments-veterinaires","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/ema-issues-final-elemental-impurity-risk-management-guidance-for-veterinary-medicinal-products\/","title":{"rendered":"L&#039;EMA publie la version finale de ses lignes directrices sur la gestion des risques li\u00e9s aux impuret\u00e9s \u00e9l\u00e9mentaires\u2026"},"content":{"rendered":"<p>Sur <strong>20 f\u00e9vrier 2026,<\/strong> le <strong>Agence europ\u00e9enne des m\u00e9dicaments<\/strong> publi\u00e9 <strong>orientations finales<\/strong> d\u00e9finition des exigences en mati\u00e8re de gestion des risques pour <strong>impuret\u00e9s \u00e9l\u00e9mentaires dans tous les m\u00e9dicaments v\u00e9t\u00e9rinaires (MV),<\/strong> y compris <strong>produits biologiques, produits immunologiques tels que les vaccins et th\u00e9rapies novatrices.<\/strong> Ces recommandations s&#039;adressent aux fabricants responsables de la qualit\u00e9, de la s\u00e9curit\u00e9 et de la conformit\u00e9 r\u00e9glementaire des produits pharmaceutiques v\u00e9t\u00e9rinaires utilis\u00e9s chez les animaux.<\/p>\n<div class=\"row\"  id=\"row-142919792\">\n\n\t<div id=\"col-1909041986\" 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-1331585239\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1331585239 {\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-877884423\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-877884423 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ces lignes directrices \u00e9tablissent une approche harmonis\u00e9e \u00e0 l&#039;\u00e9gard de <strong>identification, \u00e9valuation et contr\u00f4le des impuret\u00e9s \u00e9l\u00e9mentaires,<\/strong> y compris les m\u00e9taux lourds, dans toutes les cat\u00e9gories de VMP. Il est pr\u00e9cis\u00e9 que les fabricants sont tenus de les appliquer <strong>Principes de gestion des risques conformes aux exigences de la Pharmacop\u00e9e europ\u00e9enne,<\/strong> m\u00eame pour les types de produits v\u00e9t\u00e9rinaires qui \u00e9taient auparavant exclus des lignes directrices comparables relatives aux m\u00e9dicaments \u00e0 usage humain.<\/p>\n<p>Le document d\u00e9finit les attentes quant \u00e0 la mani\u00e8re<strong> Des \u00e9valuations des risques doivent \u00eatre r\u00e9alis\u00e9es et document\u00e9es.,<\/strong> y compris l&#039;exigence que les r\u00e9sultats de l&#039;\u00e9valuation des risques soient r\u00e9sum\u00e9s dans<strong> Dossiers r\u00e9glementaires pour les demandes de nouveaux produits.<\/strong> Pour les produits existants, les mises \u00e0 jour de dossiers ne sont requises que lorsque la r\u00e9\u00e9valuation entra\u00eene des modifications des informations soumises.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1909041986 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-147797184\" 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-993861784\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-993861784 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Mise en \u0153uvre progressive et flexibilit\u00e9<\/h2>\n\t<div id=\"gap-1376714037\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1376714037 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Pour <strong>m\u00e9dicaments v\u00e9t\u00e9rinaires immunologiques,<\/strong> comme les vaccins, les lignes directrices introduisent un <strong>approche de mise en \u0153uvre progressive.<\/strong> Cela refl\u00e8te leur profil de risque g\u00e9n\u00e9ralement faible et offre une flexibilit\u00e9 r\u00e9glementaire suppl\u00e9mentaire tout en maintenant l&#039;alignement avec les objectifs globaux de qualit\u00e9 et de s\u00e9curit\u00e9.<\/p>\n<p>Les directives permettent \u00e9galement <strong>valeurs d&#039;exposition journali\u00e8re autoris\u00e9es<\/strong> pour les impuret\u00e9s \u00e9l\u00e9mentaires \u00e0 recalculer lorsque cela est scientifiquement justifi\u00e9, en tenant compte de <strong>esp\u00e8ces animales, poids corporel, volume de la dose et fr\u00e9quence d&#039;administration.<\/strong> Dans les cas o\u00f9 le test direct n&#039;est ni faisable ni pertinent, <strong>donn\u00e9es bibliographiques<\/strong> peuvent \u00eatre utilis\u00e9s pour \u00e9tayer les conclusions de risque n\u00e9gligeable.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-147797184 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2098656418\" 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-1327298574\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1327298574 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>Sans objet.<\/strong> Ces directives sont publi\u00e9es en tant que <strong>final<\/strong> et ne pr\u00e9voit pas de date limite pour la consultation ou les commentaires du public.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2098656418 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-867873033\" 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-1726751041\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1726751041 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives fournissent <strong>clart\u00e9 r\u00e9glementaire<\/strong> en confirmant que la gestion des risques li\u00e9s aux impuret\u00e9s \u00e9l\u00e9mentaires s&#039;applique de mani\u00e8re uniforme \u00e0 tous les m\u00e9dicaments v\u00e9t\u00e9rinaires. En alignant les attentes sur les pratiques existantes. <strong>Normes de la Pharmacop\u00e9e europ\u00e9enne,<\/strong> Il favorise l&#039;alignement num\u00e9rique et proc\u00e9dural au sein des syst\u00e8mes de qualit\u00e9, am\u00e9liore l&#039;efficacit\u00e9 des soumissions r\u00e9glementaires et limite la charge suppl\u00e9mentaire en introduisant de la flexibilit\u00e9 et une mise en \u0153uvre progressive lorsque cela est scientifiquement justifi\u00e9.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-867873033 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1294584520\" 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 cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-1998233445\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1998233445 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est pertinente pour <strong>Affaires r\u00e9glementaires, assurance qualit\u00e9, d\u00e9veloppement pharmaceutique,<\/strong> et <strong>Fabrication<\/strong> \u00e9quipes impliqu\u00e9es dans le d\u00e9veloppement, la soumission et la gestion du cycle de vie des m\u00e9dicaments v\u00e9t\u00e9rinaires, y compris les vaccins et les th\u00e9rapies avanc\u00e9es.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1294584520 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1776088174\" 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-1568774748\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1568774748 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les fabricants devraient examiner les produits existants <strong>processus d&#039;\u00e9valuation des risques li\u00e9s aux impuret\u00e9s \u00e9l\u00e9mentaires<\/strong> Pour l\u2019ensemble des portefeuilles de produits v\u00e9t\u00e9rinaires, y compris ceux pr\u00e9c\u00e9demment consid\u00e9r\u00e9s comme hors champ d\u2019application, les dossiers r\u00e9glementaires doivent \u00eatre \u00e9valu\u00e9s afin de d\u00e9terminer si des mises \u00e0 jour sont n\u00e9cessaires suite \u00e0 la r\u00e9\u00e9valuation, et d\u2019identifier les opportunit\u00e9s d\u2019exploitation.<strong> preuves bibliographiques<\/strong> devrait \u00eatre envisag\u00e9e lorsque les tests directs sont impossibles \u00e0 mettre en \u0153uvre.<\/p>\n<p>\u00c0 mesure que les organisations s&#039;adaptent \u00e0 ces nouvelles attentes en mati\u00e8re d&#039;EMA, <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> peut apporter son soutien aux \u00e9quipes en assurant une veille r\u00e9glementaire continue dans le domaine v\u00e9t\u00e9rinaire et en traduisant les exigences complexes en flux de travail de conformit\u00e9 op\u00e9rationnels. <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/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, qui permet aux organisations mondiales des secteurs hautement r\u00e9glement\u00e9s, notamment les produits de consommation et les sciences de la vie, de naviguer de mani\u00e8re proactive dans des environnements r\u00e9glementaires complexes. <strong>En combinant une IA agentique avanc\u00e9e avec des experts impliqu\u00e9s, <a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a><\/strong> 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=\"http:\/\/regask.com\/fr\/\"><strong>En savoir plus <\/strong><\/a>ou<a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"><strong> r\u00e9servez une d\u00e9mo maintenant.<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1776088174 > .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-449474068\">\n\n\t<div id=\"col-126207694\" 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-319762834\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-319762834 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>Que sont les impuret\u00e9s \u00e9l\u00e9mentaires dans les m\u00e9dicaments v\u00e9t\u00e9rinaires\u00a0?<\/h4>\n\t<div id=\"gap-1002569211\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1002569211 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les impuret\u00e9s \u00e9l\u00e9mentaires sont des \u00e9l\u00e9ments inorganiques ind\u00e9sirables, tels que les m\u00e9taux lourds, qui peuvent \u00eatre pr\u00e9sents dans les m\u00e9dicaments v\u00e9t\u00e9rinaires et n\u00e9cessitent une \u00e9valuation et un contr\u00f4le pour garantir la s\u00e9curit\u00e9 du produit.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-126207694 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-646410296\" 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>Quels m\u00e9dicaments v\u00e9t\u00e9rinaires sont concern\u00e9s par les lignes directrices de l&#039;EMA\u00a0?<\/h4>\n\t<div id=\"gap-2038756390\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2038756390 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les directives s&#039;appliquent \u00e0 <strong>tous les VMP,<\/strong> y compris <strong>produits biologiques, produits immunologiques (vaccins), <\/strong>et<strong> nouvelles th\u00e9rapies. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-646410296 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2093995700\" 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>Les m\u00e9dicaments v\u00e9t\u00e9rinaires immunologiques sont-ils soumis aux m\u00eames exigences ?<\/h4>\n\t<div id=\"gap-1416648807\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1416648807 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Oui. Les VMP immunologiques sont inclus, mais les recommandations fournissent un <strong>approche de mise en \u0153uvre progressive et flexibilit\u00e9 accrue<\/strong> en raison de leur profil de faible risque.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2093995700 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-12919167\" 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 la norme RegASK peut-elle aider les entreprises \u00e0 se conformer aux directives de l&#039;EMA concernant les impuret\u00e9s \u00e9l\u00e9mentaires\u00a0?<\/h4>\n\t<div id=\"gap-548621461\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-548621461 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> aide les \u00e9quipes r\u00e9glementaires et qualit\u00e9 \u00e0 suivre les mises \u00e0 jour des directives de l&#039;EMA, \u00e0 \u00e9valuer leur impact sur les portefeuilles de produits v\u00e9t\u00e9rinaires et \u00e0 g\u00e9rer les exigences en mati\u00e8re d&#039;\u00e9valuation des risques et de documentation gr\u00e2ce \u00e0 une intelligence r\u00e9glementaire bas\u00e9e sur l&#039;IA et \u00e0 l&#039;automatisation des flux de travail.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-12919167 > .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 February 20, 2026, the European Medicines Agency published final guidance setting out risk management requirements for elemental impurities in all veterinary medicinal products (VMPs), including biologicals, immunologicals such as vaccines, and novel therapies. The guidance applies to manufacturers responsible for the quality, safety, and regulatory compliance of veterinary pharmaceuticals used in animals.<\/p>","protected":false},"author":41,"featured_media":9535,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33,39],"tags":[],"class_list":["post-9534","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news","category-medical-devices-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 Issues Final Elemental Impurity Guidance Released<\/title>\n<meta name=\"description\" content=\"Explore the EMA&#039;s final guidance on elemental impurity risk management for veterinary medicinal products and its impact on manufacturers.\" 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