{"id":9589,"date":"2026-03-03T22:23:32","date_gmt":"2026-03-03T14:23:32","guid":{"rendered":"https:\/\/regask.com\/?p=9589"},"modified":"2026-03-03T22:23:32","modified_gmt":"2026-03-03T14:23:32","slug":"la-fda-publie-un-projet-de-lignes-directrices-specifiques-aux-produits-pour-soutenir-le-developpement-des-medicaments-generiques-et-les-approbations-anda","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-issues-draft-product-specific-guidances-to-support-generic-drug-development-and-anda-approvals\/","title":{"rendered":"La FDA publie un projet de lignes directrices sp\u00e9cifiques aux produits pour soutenir\u2026"},"content":{"rendered":"<p>Sur <strong>26 f\u00e9vrier 2026, <\/strong>le<strong> L&#039;Agence am\u00e9ricaine des produits alimentaires et m\u00e9dicamenteux (FDA) a publi\u00e9 une s\u00e9rie de projets de lignes directrices sp\u00e9cifiques aux produits (PSG).<\/strong> visant \u00e0 soutenir le d\u00e9veloppement et la rationalisation des m\u00e9dicaments g\u00e9n\u00e9riques <strong>Demande abr\u00e9g\u00e9e de nouveau m\u00e9dicament (ANDA)<\/strong> Approbations de produits pharmaceutiques. Cette mise \u00e0 jour concerne les entreprises et les \u00e9quipes impliqu\u00e9es dans le d\u00e9veloppement, la soumission ou l&#039;examen des demandes d&#039;autorisation de mise sur le march\u00e9 (ANDA), en particulier pour les deux <strong>produits g\u00e9n\u00e9riques complexes et non complexes. <\/strong><\/p>\n<div class=\"row\"  id=\"row-477188570\">\n\n\t<div id=\"col-606384959\" 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-304063454\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-304063454 {\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-2043311674\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2043311674 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La FDA a publi\u00e9 de nouveaux projets de PSG r\u00e9vis\u00e9s qui d\u00e9finissent les attentes r\u00e9glementaires en mati\u00e8re de d\u00e9monstration <strong>\u00e9quivalence th\u00e9rapeutique<\/strong> pour faire r\u00e9f\u00e9rence aux m\u00e9dicaments r\u00e9pertori\u00e9s. Les lignes directrices couvrent 98 produits, y compris ceux qui contiennent <strong>aucun g\u00e9n\u00e9rique actuellement approuv\u00e9,<\/strong> et introduire de nouvelles orientations pour <strong>traitements contre la d\u00e9pendance aux opio\u00efdes <\/strong>et<strong> S\u00e9maglutide oral pour la r\u00e9duction du risque cardiovasculaire.\u00a0<\/strong><\/p>\n<p>Plusieurs PSG existants ont \u00e9t\u00e9 r\u00e9vis\u00e9s, avec des mises \u00e0 jour affectant <strong>formulations \u00e0 lib\u00e9ration modifi\u00e9e et syst\u00e8mes transdermiques et topiques,<\/strong> ce qui entra\u00eene des changements dans les attentes relatives aux \u00e9tudes, tels que<strong> \u00e9tudes sur la lib\u00e9ration de doses d&#039;alcool <\/strong>et<strong> Tests de sensibilisation.<\/strong> De plus, la FDA a mis \u00e0 jour sa liste en ligne pour inclure <strong>Prochainement, des PSG en cours de d\u00e9veloppement,<\/strong> ainsi que les dates de publication pr\u00e9vues pour appuyer la planification du d\u00e9veloppement.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-606384959 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-987443188\" 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-1087818805\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1087818805 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ces PSG de draft offrent une plus grande <strong>clart\u00e9 r\u00e9glementaire<\/strong> sur la conception des \u00e9tudes et les exigences en mati\u00e8re de donn\u00e9es pour le d\u00e9veloppement des m\u00e9dicaments g\u00e9n\u00e9riques, en soutenant <strong>efficacit\u00e9 de l&#039;alignement num\u00e9rique et de la planification<\/strong> pour les programmes ANDA. En clarifiant les attentes concernant les produits complexes et non complexes, la mise \u00e0 jour vise \u00e0 am\u00e9liorer la pr\u00e9visibilit\u00e9 tout en maintenant un <strong>impact neutre et charge r\u00e9glementaire suppl\u00e9mentaire minimale<\/strong> pour les acteurs du secteur.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-987443188 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1444634493\" 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-1577065270\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1577065270 {\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, recherche et d\u00e9veloppement, <\/strong>et<strong> \u00e9quipes juridiques<\/strong> impliqu\u00e9s dans le d\u00e9veloppement de m\u00e9dicaments g\u00e9n\u00e9riques et les soumissions ANDA, en particulier ceux qui travaillent sur des formulations complexes ou des produits dont les exigences en mati\u00e8re d&#039;\u00e9tudes \u00e9voluent.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1444634493 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-510507226\" 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-1942299453\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1942299453 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les entreprises devraient <strong>\u00e9valuer les demandes d&#039;autorisation de mise sur le march\u00e9 (ANDA) actuelles et pr\u00e9vues<\/strong> Comparer les r\u00e9sultats aux PSG r\u00e9cemment publi\u00e9s et r\u00e9vis\u00e9s afin d&#039;identifier toute lacune dans les protocoles d&#039;\u00e9tude ou les ensembles de donn\u00e9es. Lorsque des programmes de d\u00e9veloppement peuvent \u00eatre affect\u00e9s, les candidats peuvent <strong>demander des t\u00e9l\u00e9conf\u00e9rences avec la FDA <\/strong>sous<strong> Engagements du GDUFA III.<\/strong> Il est recommand\u00e9 de suivre en permanence les listes PSG de la FDA afin d&#039;anticiper les futures orientations relatives aux portefeuilles de produits.<\/p>\n<p>Face \u00e0 l&#039;\u00e9volution constante des exigences r\u00e9glementaires concernant les m\u00e9dicaments g\u00e9n\u00e9riques, il est essentiel, pour une planification efficace du d\u00e9veloppement, de rester \u00e0 l&#039;avant-garde des projets et des futures directives de r\u00e9glementation. <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,<\/strong> <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> Fournit des informations pr\u00e9dictives exploitables en temps opportun et une automatisation de bout en bout, aidant les \u00e9quipes \u00e0 suivre les mises \u00e0 jour des directives de la FDA, \u00e0 \u00e9valuer l&#039;impact sur les programmes ANDA et \u00e0 rationaliser les flux de travail de conformit\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.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-510507226 > .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-1432756213\">\n\n\t<div id=\"col-1145061300\" 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-1724449107\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1724449107 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW45210204 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45210204 BCX0\">Quoi\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed GrammarErrorHighlight SCXW45210204 BCX0\">sont<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0Sp\u00e9cifique au produit de la FDA\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW45210204 BCX0\">conseils<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0(PSG) ?<\/span><\/span><span class=\"EOP SCXW45210204 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1791743876\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1791743876 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les PSG de la FDA sont des documents d&#039;orientation qui d\u00e9crivent les plans d&#039;\u00e9tude recommand\u00e9s et les exigences en mati\u00e8re de donn\u00e9es pour d\u00e9montrer l&#039;\u00e9quivalence th\u00e9rapeutique dans les demandes d&#039;autorisation de mise sur le march\u00e9 de m\u00e9dicaments g\u00e9n\u00e9riques.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1145061300 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-261391099\" 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 SCXW266917646 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266917646 BCX0\">Combien de produits sont concern\u00e9s par la mise \u00e0 jour provisoire du PSG de f\u00e9vrier 2026\u00a0?<\/span><\/span><span class=\"EOP SCXW266917646 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-58345924\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-58345924 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">Le projet de mise \u00e0 jour de la FDA couvre\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">98 produits<\/span><\/span><span class=\"TextRun SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">, y compris les versions nouvelles et r\u00e9vis\u00e9es\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW195383774 BCX0\">conseils<\/span><span class=\"NormalTextRun SCXW195383774 BCX0\">.<\/span><\/span><span class=\"EOP SCXW195383774 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-261391099 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1346122935\" 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 SCXW234189171 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234189171 BCX0\">Quels types de produits g\u00e9n\u00e9riques sont les plus touch\u00e9s par cette mise \u00e0 jour\u00a0?<\/span><\/span><span class=\"EOP SCXW234189171 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1586561920\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1586561920 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La mise \u00e0 jour affecte particuli\u00e8rement <strong>produits complexes, formulations \u00e0 lib\u00e9ration modifi\u00e9e, syst\u00e8mes transdermiques et topiques,<\/strong> ainsi que des produits pour <strong>trouble li\u00e9 \u00e0 l&#039;utilisation d&#039;opio\u00efdes et s\u00e9maglutide oral. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1346122935 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-805465223\" 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 SCXW39904085 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW39904085 BCX0\">Comment peut-on\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW39904085 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW39904085 BCX0\">\u00a0Aider les \u00e9quipes \u00e0 g\u00e9rer les mises \u00e0 jour du PSG de la FDA\u00a0?<\/span><\/span><span class=\"EOP SCXW39904085 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-430685492\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-430685492 {\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 de d\u00e9veloppement \u00e0 suivre les projets et les versions finales des PSG, \u00e0 \u00e9valuer leur impact sur les programmes ANDA en cours et \u00e0 coordonner les flux de travail r\u00e9glementaires gr\u00e2ce \u00e0 des informations bas\u00e9es sur l&#039;IA et soutenues par des experts impliqu\u00e9s.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-805465223 > .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 26, 2026, the U.S. Food and Drug Administration (FDA) published a batch of draft product-specific guidances (PSGs) aimed at supporting generic drug development and streamlining Abbreviated New Drug Application (ANDA) approvals for pharmaceuticals. The update affects companies and teams involved in developing, submitting, or reviewing ANDAs, particularly for both complex and non-complex generic&#8230;<\/p>","protected":false},"author":41,"featured_media":9590,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9589","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 v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Issues Draft Product-Specific Guidances Overview<\/title>\n<meta name=\"description\" content=\"Explore the FDA issues regarding product-specific guidances to support generic drug development and ANDA approvals in 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