{"id":9630,"date":"2026-03-11T15:38:40","date_gmt":"2026-03-11T07:38:40","guid":{"rendered":"https:\/\/regask.com\/?p=9630"},"modified":"2026-03-11T15:38:40","modified_gmt":"2026-03-11T07:38:40","slug":"la-fda-lance-une-consultation-publique-sur-la-mise-a-jour-des-lignes-directrices-du-supac-relatives-aux-modifications-apportees-a-la-fabrication-des-produits-pharmaceutiques-apres-autorisation-de-mise","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/","title":{"rendered":"La FDA lance une consultation publique sur la mise \u00e0 jour des lignes directrices du SUPAC\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">Sur\u00a0<\/span><b><span data-contrast=\"auto\">3 mars 2026<\/span><\/b><span data-contrast=\"auto\">, le\u00a0<\/span><b><span data-contrast=\"auto\">Administration am\u00e9ricaine des aliments et des m\u00e9dicaments (FDA)<\/span><\/b><span data-contrast=\"auto\">\u00a0a annonc\u00e9 une consultation publique sollicitant des commentaires sur son\u00a0<\/span><b><span data-contrast=\"auto\">Lignes directrices relatives \u00e0 la mise \u00e0 l&#039;\u00e9chelle et aux modifications post-approbation (SUPAC)<\/span><\/b><span data-contrast=\"auto\">\u00a0pour les produits pharmaceutiques. La consultation porte sur\u00a0<\/span><b><span data-contrast=\"auto\">chimie, fabrication et contr\u00f4les (CMC)<\/span><\/b><span data-contrast=\"auto\">\u00a0exigences et objectifs d&#039;\u00e9valuation de la pertinence et de l&#039;ad\u00e9quation des documents d&#039;orientation existants du SUPAC aux normes scientifiques et r\u00e9glementaires actuelles.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">L&#039;examen porte sur les lignes directrices de la SUPAC concernant\u00a0<\/span><b><span data-contrast=\"auto\">publication imm\u00e9diate<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">version modifi\u00e9e<\/span><\/b><span data-contrast=\"auto\">, et\u00a0<\/span><b><span data-contrast=\"auto\">formes posologiques semi-solides non st\u00e9riles<\/span><\/b><span data-contrast=\"auto\">, ainsi que les changements li\u00e9s \u00e0\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9quipement de fabrication<\/span><\/b><span data-contrast=\"auto\">. Les acteurs de l&#039;ensemble de l&#039;industrie pharmaceutique sont invit\u00e9s \u00e0 soumettre leurs commentaires afin de d\u00e9terminer si des r\u00e9visions, des clarifications ou des sujets suppl\u00e9mentaires devraient \u00eatre int\u00e9gr\u00e9s \u00e0 la mise \u00e0 jour des lignes directrices.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">La p\u00e9riode de consultation reste ouverte jusqu&#039;\u00e0\u00a0<\/span><b><span data-contrast=\"auto\">1er juin 2026<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-117522130\">\n\n\t<div id=\"col-871458362\" 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-728507818\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-728507818 {\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-1589542010\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1589542010 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La FDA sollicite des commentaires sur le\u00a0<\/span><b><span data-contrast=\"auto\">utilit\u00e9, clart\u00e9 et applicabilit\u00e9<\/span><\/b><span data-contrast=\"auto\">\u00a0des lignes directrices actuelles de la SUPAC qui traitent de l&#039;augmentation de l&#039;\u00e9chelle de production et des modifications post-approbation des produits pharmaceutiques.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">L&#039;examen porte sp\u00e9cifiquement sur la question de savoir si les documents d&#039;orientation existants pour\u00a0<\/span><b><span data-contrast=\"auto\">publication imm\u00e9diate<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">version modifi\u00e9e<\/span><\/b><span data-contrast=\"auto\">, et\u00a0<\/span><b><span data-contrast=\"auto\">formes posologiques semi-solides non st\u00e9riles<\/span><\/b><span data-contrast=\"auto\">\u00a0continuer \u00e0 soutenir une surveillance r\u00e9glementaire efficace des changements CMC. L&#039;agence \u00e9value \u00e9galement des orientations relatives \u00e0\u00a0<\/span><b><span data-contrast=\"auto\">changements d&#039;\u00e9quipement de fabrication<\/span><\/b><span data-contrast=\"auto\">, ce qui peut avoir un impact sur les processus de fabrication et les syst\u00e8mes de qualit\u00e9.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">En outre, la FDA examine si ces documents restent conformes aux cadres r\u00e9glementaires internationaux les plus r\u00e9cents, notamment\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1) sur la gestion des risques qualit\u00e9<\/span><\/b><span data-contrast=\"auto\">\u00a0et\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12 sur la gestion du cycle de vie des produits pharmaceutiques<\/span><\/b><span data-contrast=\"auto\">. L\u2019agence encourage les parties prenantes \u00e0 identifier les difficult\u00e9s rencontr\u00e9es pour interpr\u00e9ter ou mettre en \u0153uvre les recommandations du SUPAC dans leurs pratiques actuelles.\u00a0<\/span><b><span data-contrast=\"auto\">syst\u00e8mes de qualit\u00e9 pharmaceutique<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Les acteurs du secteur peuvent \u00e9galement sugg\u00e9rer\u00a0<\/span><b><span data-contrast=\"auto\">nouveaux sujets, mises \u00e0 jour ou r\u00e9visions<\/span><\/b><span data-contrast=\"auto\">\u00a0cela pourrait am\u00e9liorer la pertinence des lignes directrices tout en contribuant \u00e0 r\u00e9duire la complexit\u00e9 r\u00e9glementaire ou les charges inutiles.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-871458362 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1852836914\" 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-1880328763\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1880328763 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">Les parties prenantes sont invit\u00e9es \u00e0\u00a0<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">soumettre<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">\u00a0commentaires sur l&#039;examen des lignes directrices SUPAC de la FDA par\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">1er juin 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\"><strong>.<\/strong> Les soumissions peuvent \u00eatre effectu\u00e9es via le\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">Les canaux \u00e9lectroniques ou \u00e9crits sp\u00e9cifi\u00e9s par la FDA<\/span><\/span><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">.<\/span><\/span><span class=\"EOP SCXW54403655 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1852836914 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-893939934\" 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-1385668474\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1385668474 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les lignes directrices de la SUPAC jouent un r\u00f4le important dans la d\u00e9finition de la mani\u00e8re dont les fabricants de produits pharmaceutiques g\u00e8rent\u00a0<\/span><b><span data-contrast=\"auto\">modifications apport\u00e9es aux processus de fabrication et de contr\u00f4le de la qualit\u00e9 apr\u00e8s approbation<\/span><\/b><span data-contrast=\"auto\">. En examinant ces documents, la FDA vise \u00e0 s&#039;assurer qu&#039;ils refl\u00e8tent\u00a0<\/span><b><span data-contrast=\"auto\">normes scientifiques actuelles, approches r\u00e9glementaires fond\u00e9es sur les risques et alignement sur les cadres internationaux<\/span><\/b><span data-contrast=\"auto\">\u00a0tel que\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1)<\/span><\/b><span data-contrast=\"auto\">\u00a0et\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">La mise \u00e0 jour de ces recommandations pourrait favoriser une plus grande efficacit\u00e9.\u00a0<\/span><b><span data-contrast=\"auto\">Clart\u00e9 r\u00e9glementaire, alignement num\u00e9rique des syst\u00e8mes de qualit\u00e9 et gestion efficace du cycle de vie des produits pharmaceutiques<\/span><\/b><span data-contrast=\"auto\">, tout en minimisant les contraintes r\u00e9glementaires inutiles pour les fabricants.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-893939934 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1907250094\" 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-1344250417\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1344250417 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">Cette consultation est particuli\u00e8rement pertinente pour\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00e9quipes des affaires r\u00e9glementaires, professionnels de l&#039;assurance qualit\u00e9 (AQ), sp\u00e9cialistes de la fabrication et des CMC, et responsables de la conformit\u00e9 pharmaceutique<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\"><strong>\u00a0<\/strong>responsable de la gestion\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">activit\u00e9s de mise \u00e0 l&#039;\u00e9chelle et\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW159808703 BCX0\">post-approbation<\/span><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0changements<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0dans des environnements de fabrication pharmaceutique r\u00e9glement\u00e9s.<\/span><\/span><span class=\"EOP SCXW159808703 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1907250094 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-657900929\" 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-1486753935\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1486753935 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les organisations devraient revoir leurs pratiques actuelles\u00a0<\/span><b><span data-contrast=\"auto\">proc\u00e9dures internes de gestion des changements de production li\u00e9s \u00e0 la mont\u00e9e en \u00e9chelle et \u00e0 l&#039;approbation<\/span><\/b><span data-contrast=\"auto\">\u00a0par rapport aux lignes directrices SUPAC existantes. Les \u00e9quipes r\u00e9glementaires et qualit\u00e9 pourraient envisager d&#039;identifier les domaines o\u00f9\u00a0<\/span><b><span data-contrast=\"auto\">clarification, modernisation ou orientations suppl\u00e9mentaires<\/span><\/b><span data-contrast=\"auto\">\u00a0am\u00e9liorerait la mise en \u0153uvre ou r\u00e9duirait la complexit\u00e9 op\u00e9rationnelle.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Les entreprises peuvent \u00e9galement tirer profit d&#039;une coordination\u00a0<\/span><b><span data-contrast=\"auto\">retour d&#039;information interfonctionnel entre les \u00e9quipes r\u00e9glementaires, qualit\u00e9 et production<\/span><\/b><span data-contrast=\"auto\">\u00a0\u00e9laborer une r\u00e9ponse exhaustive avant de soumettre des commentaires \u00e0 la FDA avant la\u00a0<\/span><b><span data-contrast=\"auto\">Date limite : 1er juin 2026<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Les attentes r\u00e9glementaires autour\u00a0<\/span><b><span data-contrast=\"auto\">Gestion du cycle de vie CMC et contr\u00f4le des changements bas\u00e9 sur les risques<\/span><\/b><span data-contrast=\"auto\">\u00a0Les outils de veille et de surveillance r\u00e9glementaires continuent d&#039;\u00e9voluer et peuvent aider les organisations \u00e0 suivre les consultations et \u00e0 anticiper les changements r\u00e9glementaires potentiels.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><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 internationales des secteurs fortement 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. En combinant des technologies avanc\u00e9es <strong>IA agentique<\/strong> avec des experts impliqu\u00e9s, <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/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=\"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><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-657900929 > .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-1797050541\">\n\n\t<div id=\"col-875972994\" 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-686373693\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-686373693 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW116607224 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">Que demande la FDA ?\u00a0<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">retour<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0dans la consultation SUPAC ?<\/span><\/span><span class=\"EOP SCXW116607224 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1861571947\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1861571947 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">La FDA sollicite les commentaires du public sur le<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">Pertinence, clart\u00e9 et utilit\u00e9 des SUPAC existants\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">conseils<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0cette adresse\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">mise \u00e0 l&#039;\u00e9chelle et\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">post-approbation<\/span><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0changements<\/span><\/span><\/strong><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\"><strong>\u00a0<\/strong>pour les produits pharmaceutiques, notamment dans le contexte de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">chimie, fabrication et contr\u00f4les (CMC)<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">.<\/span><\/span><span class=\"EOP SCXW27174500 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-875972994 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1088869606\" 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><span class=\"TextRun MacChromeBold SCXW185224076 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW185224076 BCX0\" data-ccp-parastyle=\"heading 3\">Quelles cat\u00e9gories de produits pharmaceutiques sont couvertes par l&#039;examen SUPAC\u00a0?<\/span><\/span><span class=\"EOP SCXW185224076 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-30850496\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-30850496 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">La consultation porte sur SUPAC\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW232278638 BCX0\">conseils<\/span><span class=\"NormalTextRun SCXW232278638 BCX0\">\u00a0pour\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">publication imm\u00e9diate<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">,\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">version modifi\u00e9e<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">, et\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">formes posologiques semi-solides non st\u00e9riles<\/span><\/span><\/strong><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\"><strong>,<\/strong> ainsi que des conseils relatifs \u00e0\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">changements d&#039;\u00e9quipement de fabrication<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">.<\/span><\/span><span class=\"EOP SCXW232278638 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1088869606 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2050282995\" 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><span class=\"TextRun MacChromeBold SCXW132097625 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">Quelle est la date limite pour\u00a0<\/span><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">soumettre<\/span><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0Des commentaires \u00e0 la FDA ?<\/span><\/span><span class=\"EOP SCXW132097625 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-816653411\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-816653411 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">Les parties prenantes doivent\u00a0<\/span><span class=\"NormalTextRun SCXW197707949 BCX0\">soumettre<\/span><span class=\"NormalTextRun SCXW197707949 BCX0\">\u00a0commentaires sur la r\u00e9vision des lignes directrices de la SUPAC par\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">1er juin 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\"><strong>,<\/strong> en utilisant le<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">canaux de soumission \u00e9lectroniques ou \u00e9crits sp\u00e9cifi\u00e9s par la FDA<\/span><\/span><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">.<\/span><\/span><span class=\"EOP SCXW197707949 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2050282995 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1982876667\" 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 entreprises \u00e0 suivre les mises \u00e0 jour r\u00e9glementaires relatives aux pr\u00e9parations pour nourrissons\u00a0?<\/h4>\n\t<div id=\"gap-1078970746\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1078970746 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/fr\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW67355384 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0aide les \u00e9quipes r\u00e9glementaires et de conformit\u00e9\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">moniteur<\/span><strong><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0Se tenir inform\u00e9 des \u00e9volutions r\u00e9glementaires mondiales, analyser les impacts potentiels et coordonner les r\u00e9ponses internes.<\/span><\/strong><\/span><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0aux consultations et aux r\u00e9visions des lignes directrices.\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">Plateforme de veille r\u00e9glementaire bas\u00e9e sur l&#039;IA et pilot\u00e9e par agentic<\/span><\/span><\/strong><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0permet aux organisations de suivre l&#039;\u00e9volution des cadres r\u00e9glementaires, d&#039;\u00e9valuer les risques de non-conformit\u00e9 et de rationaliser la collaboration entre les \u00e9quipes r\u00e9glementaires, qualit\u00e9 et de production.<\/span><\/span><span class=\"EOP SCXW67355384 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1982876667 > .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 3 mars 2026, la FDA (Food and Drug Administration) am\u00e9ricaine a annonc\u00e9 une consultation publique sollicitant des commentaires sur ses lignes directrices SUPAC (Scale-Up and Postapproval Changes) relatives aux produits pharmaceutiques. Cette consultation porte sur les exigences en mati\u00e8re de chimie, de fabrication et de contr\u00f4les (CMC) et vise \u00e0 \u00e9valuer la pertinence et la conformit\u00e9 des documents d&#039;orientation SUPAC existants avec les normes scientifiques et r\u00e9glementaires actuelles. L&#039;examen couvre les lignes directrices SUPAC relatives aux formes posologiques \u00e0 lib\u00e9ration imm\u00e9diate, \u00e0 lib\u00e9ration modifi\u00e9e et semi-solides non st\u00e9riles\u2026<\/p>","protected":false},"author":43,"featured_media":9631,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Opens Public Consultation on Pharmaceutical Changes<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.\" \/>\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\/la-fda-lance-une-consultation-publique-sur-la-mise-a-jour-des-lignes-directrices-du-supac-relatives-aux-modifications-apportees-a-la-fabrication-des-produits-pharmaceutiques-apres-autorisation-de-mise\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Opens Public Consultation on Updating SUPAC Guidance for Postapproval Pharmaceutical Manufacturing Changes\" \/>\n<meta property=\"og:description\" content=\"Explore the FDA&#039;s public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/la-fda-lance-une-consultation-publique-sur-la-mise-a-jour-des-lignes-directrices-du-supac-relatives-aux-modifications-apportees-a-la-fabrication-des-produits-pharmaceutiques-apres-autorisation-de-mise\/\" \/>\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=\"2026-03-11T07:38:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.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=\"Reva Ananda\" \/>\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=\"Reva Ananda\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"FDA Opens Public 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