{"id":9620,"date":"2026-03-11T14:41:45","date_gmt":"2026-03-11T06:41:45","guid":{"rendered":"https:\/\/regask.com\/?p=9620"},"modified":"2026-03-11T15:50:07","modified_gmt":"2026-03-11T07:50:07","slug":"la-fda-publie-un-projet-de-lignes-directrices-sur-lexclusivite-de-trois-ans-des-essais-cliniques-pour-les-nouvelles-demandes-dautorisation-de-mise-sur-le-marche-amm-et-leurs-supplements","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/","title":{"rendered":"La FDA publie un projet de lignes directrices sur les essais cliniques de trois ans\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">Sur\u00a0<\/span><b><span data-contrast=\"auto\">4 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 publi\u00e9 un\u00a0<\/span><b><span data-contrast=\"auto\">projet de document d&#039;orientation<\/span><\/b><span data-contrast=\"auto\">\u00a0s&#039;adresser\u00a0<\/span><b><span data-contrast=\"auto\">exclusivit\u00e9 de trois ans pour l&#039;\u00e9tude clinique<\/span><\/b><span data-contrast=\"auto\">\u00a0pour les produits pharmaceutiques. Ces lignes directrices pr\u00e9cisent les attentes r\u00e9glementaires \u00e0 l&#039;\u00e9gard des demandeurs d&#039;exclusivit\u00e9 pour\u00a0<\/span><b><span data-contrast=\"auto\">nouvelles demandes d&#039;autorisation de mise sur le march\u00e9 (AMM)<\/span><\/b><span data-contrast=\"auto\">\u00a0et\u00a0<\/span><b><span data-contrast=\"auto\">Suppl\u00e9ments NDA<\/span><\/b><span data-contrast=\"auto\">, notamment lorsque de nouvelles \u00e9tudes cliniques viennent \u00e9tayer ces demandes.<\/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\">Le projet de guide vise \u00e0 aider les candidats \u00e0 comprendre\u00a0<\/span><b><span data-contrast=\"auto\">crit\u00e8res d&#039;admissibilit\u00e9 statutaires et r\u00e9glementaires<\/span><\/b><span data-contrast=\"auto\">\u00a0requis pour obtenir\u00a0<\/span><b><span data-contrast=\"auto\">exclusivit\u00e9 de 3 ans<\/span><\/b><span data-contrast=\"auto\">. Il fournit \u00e9galement des recommandations sur le\u00a0<\/span><b><span data-contrast=\"auto\">contenu et format des demandes d&#039;exclusivit\u00e9<\/span><\/b><span data-contrast=\"auto\">, pr\u00e9sent\u00e9 dans une structure\u00a0<\/span><b><span data-contrast=\"auto\">format questions-r\u00e9ponses<\/span><\/b><span data-contrast=\"auto\">. Le document est actuellement ouvert aux commentaires du public jusqu&#039;\u00e0 nouvel ordre.\u00a0<\/span><b><span data-contrast=\"auto\">4 mai 2026<\/span><\/b><span data-contrast=\"auto\">, apr\u00e8s quoi la FDA examinera les commentaires des parties prenantes avant de finaliser les 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<div class=\"row\"  id=\"row-1781579016\">\n\n\t<div id=\"col-1654579488\" 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-373877056\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-373877056 {\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-171955187\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-171955187 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Le projet de lignes directrices d\u00e9crit\u00a0<\/span><b><span data-contrast=\"auto\">normes de documentation<\/span><\/b><span data-contrast=\"auto\">\u00a0que les candidats doivent suivre lorsqu&#039;ils demandent\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9tude clinique d&#039;exclusivit\u00e9 sur trois ans<\/span><\/b><span data-contrast=\"auto\">. Il fournit des recommandations d\u00e9taill\u00e9es sur la mani\u00e8re de pr\u00e9senter les informations requises pour appuyer une demande d&#039;exclusivit\u00e9 dans le cadre d&#039;une demande d&#039;autorisation de mise sur le march\u00e9 (AMM) ou d&#039;un suppl\u00e9ment \u00e0 une AMM.<\/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\">Ces directives s&#039;appliquent aux deux\u00a0<\/span><b><span data-contrast=\"auto\">Accords de confidentialit\u00e9 originaux<\/span><\/b><span data-contrast=\"auto\">\u00a0et\u00a0<\/span><b><span data-contrast=\"auto\">Suppl\u00e9ments NDA<\/span><\/b><span data-contrast=\"auto\">\u00a0qui d\u00e9pendent de\u00a0<\/span><b><span data-contrast=\"auto\">nouvelles \u00e9tudes cliniques<\/span><\/b><span data-contrast=\"auto\">. En clarifiant les attentes concernant le format et les informations justificatives requises, la FDA vise \u00e0 am\u00e9liorer la coh\u00e9rence dans la mani\u00e8re dont les demandeurs soumettent leurs demandes d&#039;exclusivit\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\">L&#039;agence pr\u00e9cise par ailleurs que ces directives continueront d&#039;\u00e9voluer.\u00a0<\/span><b><span data-contrast=\"auto\">Les prochaines mises \u00e0 jour pourront inclure des questions et r\u00e9ponses suppl\u00e9mentaires.<\/span><\/b><span data-contrast=\"auto\">\u00a0\u00e0 mesure que de nouveaux sc\u00e9narios r\u00e9glementaires apparaissent et que les commentaires des parties prenantes sont pris en compte.<\/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-1654579488 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2128180706\" 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-504408477\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-504408477 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">Les parties prenantes peuvent\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">soumettre<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0commentaires sur le\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">Projet de lignes directrices de la FDA\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">concernant<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\"> exclusivit\u00e9 de trois ans pour l&#039;\u00e9tude clinique\u00a0<\/span><\/span><\/strong><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">jusqu&#039;\u00e0 <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">4 mai 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\"><strong>.<\/strong> Les commentaires peuvent \u00eatre\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">soumis<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0par le biais de la FDA\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">canaux de soumission en ligne ou \u00e9crits<\/span><\/span><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">.<\/span><\/span><span class=\"EOP SCXW57646166 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-2128180706 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1714136035\" 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-73462696\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-73462696 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">Le projet de lignes directrices pr\u00e9voit une plus grande\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">clart\u00e9 r\u00e9glementaire<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u00a0concernant les crit\u00e8res d&#039;admissibilit\u00e9 et les exigences en mati\u00e8re de documentation pour\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">exclusivit\u00e9 des donn\u00e9es pendant trois ans<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u00a0associ\u00e9s aux autorisations de mise sur le march\u00e9 des m\u00e9dicaments aux \u00c9tats-Unis. Des attentes plus claires peuvent contribuer \u00e0 simplifier la pr\u00e9paration des dossiers de soumission et \u00e0 soutenir<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">coh\u00e9rence r\u00e9glementaire<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\"><strong>,<\/strong> et r\u00e9duire l&#039;incertitude pour les promoteurs pr\u00e9parant des demandes d&#039;autorisation de mise sur le march\u00e9 ou des suppl\u00e9ments s&#039;appuyant sur de nouvelles investigations cliniques.<\/span><\/span><span class=\"EOP SCXW213098303 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-1714136035 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1689704035\" 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-1069604272\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1069604272 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">Cette mise \u00e0 jour est particuli\u00e8rement pertinente pour\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">fabricants de produits pharmaceutiques, promoteurs d&#039;essais cliniques, \u00e9quipes des affaires r\u00e9glementaires et professionnels de la conformit\u00e9<\/span><\/span><\/strong><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">\u00a0responsable de la pr\u00e9paration\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\"><strong>Demandes d&#039;autorisation de mise sur le march\u00e9 (AMM) ou suppl\u00e9ments appuy\u00e9s par des \u00e9tudes cliniques<\/strong><\/span><\/span><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\"><strong>.<\/strong> Les organismes impliqu\u00e9s dans le d\u00e9veloppement de m\u00e9dicaments et les processus d&#039;autorisation de mise sur le march\u00e9 aux \u00c9tats-Unis devraient examiner le projet de lignes directrices afin d&#039;en comprendre les implications pour les demandes d&#039;exclusivit\u00e9.<\/span><\/span><span class=\"EOP SCXW4282818 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-1689704035 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1112871889\" 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-1572990371\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1572990371 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les \u00e9quipes r\u00e9glementaires devraient examiner\u00a0<\/span><b><span data-contrast=\"auto\">Projet de lignes directrices de la FDA sur l&#039;exclusivit\u00e9 de trois ans des essais cliniques<\/span><\/b><span data-contrast=\"auto\">\u00a0et \u00e9valuer comment cela pourrait affecter\u00a0<\/span><b><span data-contrast=\"auto\">Soumissions actuelles ou pr\u00e9vues de NDA et de suppl\u00e9ments NDA<\/span><\/b><span data-contrast=\"auto\">. Les parties prenantes peuvent \u00e9galement envisager de pr\u00e9parer des commentaires, des suggestions ou des questions de clarification \u00e0 soumettre avant la r\u00e9union.\u00a0<\/span><b><span data-contrast=\"auto\">Date limite pour soumettre des commentaires : 4 mai 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 organisations g\u00e9rant de multiples soumissions r\u00e9glementaires sur diff\u00e9rents march\u00e9s peuvent \u00e9galement b\u00e9n\u00e9ficier d&#039;outils centralis\u00e9s de veille r\u00e9glementaire qui permettent de suivre l&#039;\u00e9volution des directives et des attentes en mati\u00e8re de soumission.<\/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>\u00a0est un leader\u00a0<\/span><b><span data-contrast=\"auto\">plateforme de renseignement r\u00e9glementaire et d&#039;orchestration des flux de travail d&#039;IA agentique<\/span><\/b><span data-contrast=\"auto\">\u00a0qui 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\u00a0<\/span><b><span data-contrast=\"auto\">IA agentique<\/span><\/b><span data-contrast=\"auto\">\u00a0avec des experts impliqu\u00e9s,\u00a0<a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a>\u00a0fournit 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\u00a0<\/span><b><span data-contrast=\"auto\">160 pays<\/span><\/b><span data-contrast=\"auto\">. <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-1112871889 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1868404467\" 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-809466678\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-809466678 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les parties prenantes devraient examiner <strong>Ressources Web mises \u00e0 jour de la FDA sur les pr\u00e9parations pour nourrissons<\/strong> et les nouveaux <strong>liste de march\u00e9 publi\u00e9e<\/strong> afin de garantir la coh\u00e9rence entre les documents internes et les informations produits destin\u00e9es au public.<\/p>\n<p>Les \u00e9quipes r\u00e9glementaires, qualit\u00e9 et commerciales doivent v\u00e9rifier que <strong>Les listes de produits et les informations sur l&#039;entreprise sont refl\u00e9t\u00e9es avec exactitude.<\/strong> dans la base de donn\u00e9es publique. Les organisations peuvent \u00e9galement envisager de suivre les futures initiatives de transparence dans le cadre de <strong>Op\u00e9ration Vitesse Cigogne<\/strong> se tenir inform\u00e9 des \u00e9volutions politiques ou des mesures r\u00e9glementaires potentielles.<\/p>\n<p>\u00c0 mesure que les initiatives de transparence r\u00e9glementaire continuent d&#039;\u00e9voluer, il devient de plus en plus important de rester inform\u00e9 des mises \u00e0 jour r\u00e9glementaires mondiales. <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> aide les organisations \u00e0 suivre l&#039;\u00e9volution de la r\u00e9glementation et \u00e0 g\u00e9rer la conformit\u00e9 des flux de travail dans plusieurs juridictions.<\/p>\n<p><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<strong><a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"> r\u00e9servez une d\u00e9mo maintenant.<\/a>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1868404467 > .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-2061568503\">\n\n\t<div id=\"col-2000786048\" 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-1481498332\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1481498332 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW99703309 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW99703309 BCX0\" data-ccp-parastyle=\"heading 3\">Quel est le projet de lignes directrices de la FDA concernant l&#039;exclusivit\u00e9 de trois ans des essais cliniques\u00a0?<\/span><\/span><span class=\"EOP SCXW99703309 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-492055587\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-492055587 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Le\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Projet de lignes directrices de la FDA publi\u00e9 le 4 mars,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW263241192 BCX0\">2026<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>\u00a0<\/strong>fournit des recommandations aux candidats qui recherchent<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">exclusivit\u00e9 de trois ans pour l&#039;\u00e9tude clinique<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0pour\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">nouvelles demandes d&#039;autorisation de mise sur le march\u00e9 (AMM)<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">ou<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Suppl\u00e9ments NDA<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>.<\/strong>\u00a0<\/span><span class=\"NormalTextRun SCXW263241192 BCX0\">Cela explique le\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">crit\u00e8res d&#039;admissibilit\u00e9<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>\u00a0<\/strong>et d\u00e9crit le\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">contenu et format<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0attendu pour les demandes d&#039;exclusivit\u00e9.<\/span><\/span><span class=\"EOP SCXW263241192 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-2000786048 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2068001761\" 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 SCXW114531365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW114531365 BCX0\" data-ccp-parastyle=\"heading 3\">Qui peut demander une exclusivit\u00e9 de trois ans pour une \u00e9tude clinique ?<\/span><\/span><span class=\"EOP SCXW114531365 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-751796757\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-751796757 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">Candidats\u00a0<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">soumission<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">Demandes d&#039;autorisation de mise sur le march\u00e9 (AMM) initiales ou suppl\u00e9ments \u00e0 une AMM \u00e9tay\u00e9s par de nouvelles investigations cliniques<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0peut demander\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">exclusivit\u00e9 de trois ans<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\"><strong>,<\/strong> \u00e0 condition qu&#039;ils satisfassent aux exigences l\u00e9gales et r\u00e9glementaires d&#039;admissibilit\u00e9 d\u00e9finies par la FDA.<\/span><\/span><span class=\"EOP SCXW124616724 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-2068001761 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1474575058\" 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 SCXW110399116 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">Quelle est la date limite pour\u00a0<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">soumettre<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0Des commentaires sur le projet de lignes directrices de la FDA\u00a0?<\/span><\/span><span class=\"EOP SCXW110399116 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-115654120\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-115654120 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">Les parties prenantes peuvent\u00a0<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">soumettre<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">\u00a0commentaires sur le\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">projet de lignes directrices<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">jusqu&#039;\u00e0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">4 mai 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\"><strong>,<\/strong> en utilisant les directives de la FDA\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">canaux de soumission en ligne ou \u00e9crits<\/span><\/span><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">.<\/span><\/span><span class=\"EOP SCXW109329519 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-1474575058 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-963714550\" 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 aider les entreprises \u00e0 g\u00e9rer les exigences d&#039;\u00e9tiquetage des OGM\u00a0?<\/h4>\n\t<div id=\"gap-1271330261\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1271330261 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/fr\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW19024172 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0fournit\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">Intelligence r\u00e9glementaire et automatisation des flux de travail bas\u00e9es sur l&#039;IA<\/span><\/span><\/strong><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0qui permet aux organisations de\u00a0<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">moniteur<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">Mises \u00e0 jour des directives de la FDA, modifications r\u00e9glementaires et exigences de soumission<\/span><\/span><\/strong><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0sur les march\u00e9s mondiaux. Cela permet aux \u00e9quipes charg\u00e9es des affaires r\u00e9glementaires et de la conformit\u00e9 de rester inform\u00e9es, d&#039;\u00e9valuer l&#039;impact r\u00e9glementaire et de simplifier la pr\u00e9paration des dossiers de soumission.<\/span><\/span><span class=\"EOP SCXW19024172 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-963714550 > .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 4 mars 2026, la FDA (Food and Drug Administration) am\u00e9ricaine a publi\u00e9 un projet de document d&#039;orientation relatif \u00e0 l&#039;exclusivit\u00e9 de trois ans des essais cliniques pour les m\u00e9dicaments. Ce document pr\u00e9cise les attentes r\u00e9glementaires \u00e0 l&#039;\u00e9gard des demandeurs d&#039;autorisation de mise sur le march\u00e9 (AMM) et de leurs suppl\u00e9ments, notamment lorsque de nouveaux essais cliniques \u00e9tayent ces demandes. Ce projet de document d&#039;orientation vise \u00e0 aider les demandeurs \u00e0 comprendre les crit\u00e8res d&#039;admissibilit\u00e9 l\u00e9gaux et r\u00e9glementaires requis pour obtenir une exclusivit\u00e9 de trois ans.<\/p>","protected":false},"author":41,"featured_media":9621,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,39],"tags":[],"class_list":["post-9620","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","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>FDA Issues Draft Guidance on Three-Year Exclusivity<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. Learn more today.\" \/>\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-publie-un-projet-de-lignes-directrices-sur-lexclusivite-de-trois-ans-des-essais-cliniques-pour-les-nouvelles-demandes-dautorisation-de-mise-sur-le-marche-amm-et-leurs-supplements\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Draft Guidance on Three-Year Clinical Investigation Exclusivity for NDAs and Supplements\" \/>\n<meta property=\"og:description\" content=\"Explore the FDA&#039;s draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. 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