{"id":9746,"date":"2026-04-01T10:27:48","date_gmt":"2026-04-01T02:27:48","guid":{"rendered":"https:\/\/regask.com\/?p=9746"},"modified":"2026-04-01T10:27:48","modified_gmt":"2026-04-01T02:27:48","slug":"le-japon-met-a-jour-la-liste-de-controle-dauto-inspection-de-la-jpma-pour-les-tests-de-qualite-dans-les-demandes-dautorisation-de-mise-sur-le-marche-de-nouveaux-medicaments","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications\/","title":{"rendered":"Le Japon met \u00e0 jour la liste de contr\u00f4le d&#039;auto-inspection de la JPMA pour la qualit\u00e9\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">Sur\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">26 mars 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\"><strong>,<\/strong> le<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">Association japonaise des fabricants de produits pharmaceutiques (JPMA) <\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">a publi\u00e9 un <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">liste de contr\u00f4le d&#039;auto-inspection r\u00e9vis\u00e9e pour les tests de qualit\u00e9<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\"><strong>,<\/strong> introduction d&#039;un cadre mis \u00e0 jour pour soutenir le\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">fiabilit\u00e9 et validit\u00e9 scientifique des donn\u00e9es sur la qualit\u00e9 des produits pharmaceutiques<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><strong><span class=\"NormalTextRun SCXW31536731 BCX0\">\u00a0<\/span><\/strong><span class=\"NormalTextRun SCXW31536731 BCX0\">soumis<\/span><span class=\"NormalTextRun SCXW31536731 BCX0\">\u00a0dans les demandes d&#039;autorisation de mise sur le march\u00e9 de nouveaux m\u00e9dicaments au Japon.<\/span><\/span><span class=\"EOP SCXW31536731 BCX0\" 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-2022160763\">\n\n\t<div id=\"col-1128555589\" 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-1977842103\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1977842103 {\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-616711916\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-616711916 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La liste de contr\u00f4le mise \u00e0 jour remplace la pr\u00e9c\u00e9dente\u00a0<\/span><b><span data-contrast=\"auto\">liste de contr\u00f4le d&#039;inspection de conformit\u00e9 bas\u00e9e sur les documents<\/span><\/b><span data-contrast=\"auto\">\u00a0et consolide\u00a0<\/span><b><span data-contrast=\"auto\">tests analytiques et tests de stabilit\u00e9 dans un cadre unifi\u00e9<\/span><\/b><span data-contrast=\"auto\">. Cette int\u00e9gration vise \u00e0 simplifier la mani\u00e8re dont les demandeurs \u00e9valuent et d\u00e9montrent la fiabilit\u00e9 des donn\u00e9es de qualit\u00e9 dans les soumissions r\u00e9glementaires.<\/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 r\u00e9vision supprime explicitement\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9l\u00e9ments d&#039;\u00e9tude non cliniques<\/span><\/b><span data-contrast=\"auto\">, en restreignant la port\u00e9e de la liste de contr\u00f4le aux tests de qualit\u00e9 pertinents pour l&#039;homologation du produit. Elle pr\u00e9cise \u00e9galement que la liste de contr\u00f4le est\u00a0<\/span><b><span data-contrast=\"auto\">il ne s&#039;agit pas d&#039;une liste exhaustive des documents requis<\/span><\/b><span data-contrast=\"auto\">, mais plut\u00f4t un outil con\u00e7u pour soutenir\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9valuation globale de la fiabilit\u00e9<\/span><\/b><span data-contrast=\"auto\">\u00a0des donn\u00e9es soumises.<\/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\">De plus, la liste de contr\u00f4le souligne que les candidats doivent s&#039;assurer que\u00a0<\/span><b><span data-contrast=\"auto\">pr\u00e9paration, d\u00e9roulement et documentation des tests<\/span><\/b><span data-contrast=\"auto\">\u00a0respecter les normes de fiabilit\u00e9 \u00e9tablies.\u00a0<\/span><b><span data-contrast=\"auto\">tests contractuels<\/span><\/b><span data-contrast=\"auto\">, Les candidats sont tenus de maintenir\u00a0<\/span><b><span data-contrast=\"auto\">m\u00e9thodes document\u00e9es pour confirmer la fiabilit\u00e9 des tests<\/span><\/b><span data-contrast=\"auto\">, renfor\u00e7ant ainsi la responsabilisation m\u00eame en cas d&#039;externalisation.<\/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\">Cette mise \u00e0 jour souligne une fois de plus l&#039;importance de\u00a0<\/span><b><span data-contrast=\"auto\">conformit\u00e9 des dossiers \u00e9lectroniques<\/span><\/b><span data-contrast=\"auto\">, exigeant le respect des proc\u00e9dures \u00e9tablies, y compris celles align\u00e9es sur\u00a0<\/span><b><span data-contrast=\"auto\">lignes directrices relatives aux documents \u00e9lectroniques et aux signatures \u00e9lectroniques<\/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\">Le\u00a0<\/span><b><span data-contrast=\"auto\">JPMA<\/span><\/b><span data-contrast=\"auto\">\u00a0note que\u00a0<\/span><b><span data-contrast=\"auto\">Des r\u00e9visions continues sont pr\u00e9vues<\/span><\/b><span data-contrast=\"auto\">\u00a0\u00e0 mesure que les pratiques du secteur continuent d&#039;\u00e9voluer.<\/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-1128555589 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-805777601\" 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-2068621425\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2068621425 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">Cette mise \u00e0 jour am\u00e9liore<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">clart\u00e9 r\u00e9glementaire<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\"><strong>\u00a0<\/strong>par\u00a0<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">consolidation<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0Il permet d&#039;int\u00e9grer les exigences en mati\u00e8re de tests de qualit\u00e9 dans un cadre unique et de supprimer les \u00e9l\u00e9ments non pertinents. Il prend en charge\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">alignement num\u00e9rique<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0gr\u00e2ce \u00e0 des attentes plus claires concernant les documents \u00e9lectroniques et am\u00e9liore\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">efficacit\u00e9 op\u00e9rationnelle<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0en simplifiant les processus d&#039;auto-inspection. Parall\u00e8lement,\u00a0<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">entretient<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0a\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">approche non prescriptive<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\"><strong>,<\/strong> minimiser les contraintes de conformit\u00e9 inutiles tout en garantissant la fiabilit\u00e9 des donn\u00e9es.<\/span><\/span><span class=\"EOP SCXW96147886 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-805777601 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1196482502\" 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>Qui est concern\u00e9 ?<\/h2>\n\t<div id=\"gap-1930038156\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1930038156 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est pertinente pour<strong> \u00e9quipes d&#039;assurance qualit\u00e9 (AQ), d&#039;affaires r\u00e9glementaires (AR) et de R&amp;D<\/strong> au sein des entreprises pharmaceutiques se pr\u00e9parant<strong> nouvelles demandes d&#039;autorisation de mise sur le march\u00e9 de m\u00e9dicaments au Japon,<\/strong> en particulier ceux qui sont impliqu\u00e9s dans <strong>tests de qualit\u00e9, int\u00e9grit\u00e9 des donn\u00e9es et pr\u00e9paration \u00e0 la soumission. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1196482502 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-345666969\" 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-69701764\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-69701764 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les organisations devraient\u00a0<\/span><b><span data-contrast=\"auto\">r\u00e9viser et mettre \u00e0 jour les proc\u00e9dures internes de contr\u00f4le qualit\u00e9 et les pratiques d&#039;auto-inspection<\/span><\/b><span data-contrast=\"auto\">\u00a0pour se conformer \u00e0 la liste de contr\u00f4le r\u00e9vis\u00e9e. Les \u00e9quipes devraient \u00e9galement\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9valuer les flux de travail documentaires actuels<\/span><\/b><span data-contrast=\"auto\">\u00a0pour garantir que\u00a0<\/span><b><span data-contrast=\"auto\">normes de validit\u00e9 scientifique, d&#039;int\u00e9grit\u00e9 des donn\u00e9es et de fiabilit\u00e9<\/span><\/b><span data-contrast=\"auto\">\u00a0sont syst\u00e9matiquement respect\u00e9es. Une coordination interfonctionnelle entre l&#039;assurance qualit\u00e9, les affaires r\u00e9glementaires et la recherche et d\u00e9veloppement sera essentielle pour garantir une parfaite conformit\u00e9 avec le cadre mis \u00e0 jour.<\/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\">Face \u00e0 l&#039;\u00e9volution constante des exigences r\u00e9glementaires en mati\u00e8re de fiabilit\u00e9 des donn\u00e9es et de conformit\u00e9 num\u00e9rique, des solutions comme\u00a0<\/span><b><span data-contrast=\"auto\">RegASK<\/span><\/b><span data-contrast=\"auto\">\u00a0peut aider les organisations \u00e0 garder une longueur d&#039;avance.\u00a0<a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a>\u00a0est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentique, qui permet aux organisations internationales des secteurs fortement r\u00e9glement\u00e9s, tels que les produits de consommation et les sciences de la vie, d&#039;anticiper les complexit\u00e9s r\u00e9glementaires. En combinant une IA agentique avanc\u00e9e et l&#039;expertise de sp\u00e9cialistes,\u00a0<a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a>\u00a0Elle 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. <strong><a href=\"http:\/\/regask.com\/fr\/\">En savoir plus<\/a> ou <a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\">r\u00e9servez une d\u00e9mo maintenant.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-345666969 > .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-1416124436\">\n\n\t<div id=\"col-80712058\" 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-839920792\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-839920792 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW96186529 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96186529 BCX0\">Quelle est la liste de contr\u00f4le d&#039;auto-inspection de la JPMA pour les tests de qualit\u00e9\u00a0?<\/span><\/span><span class=\"EOP SCXW96186529 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-1999270214\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1999270214 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Il s&#039;agit d&#039;un outil publi\u00e9 par <strong>Association japonaise des fabricants de produits pharmaceutiques (JPMA)<\/strong> pour aider les candidats \u00e0 \u00e9valuer <strong>fiabilit\u00e9 et validit\u00e9 scientifique des donn\u00e9es d&#039;essais de qualit\u00e9<\/strong> soumis dans les demandes d&#039;autorisation de mise sur le march\u00e9 de nouveaux m\u00e9dicaments.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-80712058 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-685153590\" 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 SCXW249529551 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW249529551 BCX0\">Quelles sont les principales nouveaut\u00e9s de la liste de contr\u00f4le r\u00e9vis\u00e9e\u00a0?<\/span><\/span><span class=\"EOP SCXW249529551 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-812238948\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-812238948 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">La liste de contr\u00f4le maintenant\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">int\u00e8gre les tests analytiques et de stabilit\u00e9<\/span><\/span><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">, supprime\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">\u00e9l\u00e9ments d&#039;\u00e9tude non cliniques<\/span><\/span><\/strong><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\"><strong>,<\/strong> et souligne\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">fiabilit\u00e9 des donn\u00e9es, normes de documentation et conformit\u00e9 des enregistrements \u00e9lectroniques<\/span><\/span><span class=\"TextRun SCXW114960211 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114960211 BCX0\">.<\/span><\/span><span class=\"EOP SCXW114960211 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-685153590 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-274121959\" 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 SCXW39145630 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW39145630 BCX0\">La liste de contr\u00f4le pr\u00e9cise-t-elle les documents \u00e0 soumettre\u00a0?<\/span><\/span><span class=\"EOP SCXW39145630 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-2004423911\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2004423911 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">Non. La liste de contr\u00f4le est\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">non prescriptif<\/span><\/span><\/strong><span class=\"TextRun SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">\u00a0et ne d\u00e9finit pas de liste fixe de documents requis. Il est destin\u00e9 \u00e0 soutenir\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">\u00e9valuation globale de la fiabilit\u00e9<\/span><\/span><span class=\"TextRun SCXW45445511 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45445511 BCX0\">.<\/span><\/span><span class=\"EOP SCXW45445511 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-274121959 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-377696866\" 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 SCXW241486931 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW241486931 BCX0\">Comment peut-on\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW241486931 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW241486931 BCX0\">\u00a0Besoin d&#039;aide pour la conformit\u00e9 suite \u00e0 cette mise \u00e0 jour\u00a0?<\/span><\/span><span class=\"EOP SCXW241486931 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-2130397930\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2130397930 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a>\u00a0aide les organisations \u00e0 suivre l&#039;\u00e9volution des exigences r\u00e9glementaires,\u00a0<\/span><b><span data-contrast=\"auto\">aligner les processus internes sur les cadres de r\u00e9f\u00e9rence mis \u00e0 jour<\/span><\/b><span data-contrast=\"auto\">, et assurer\u00a0<\/span><b><span data-contrast=\"auto\">int\u00e9grit\u00e9 des donn\u00e9es et pr\u00e9paration \u00e0 la soumission<\/span><\/b><span data-contrast=\"auto\">\u00a0gr\u00e2ce \u00e0 l&#039;intelligence r\u00e9glementaire pilot\u00e9e par l&#039;IA et \u00e0 l&#039;automatisation des flux de travail.<\/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-377696866 > .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 26 mars 2026, l&#039;Association japonaise des fabricants de produits pharmaceutiques (JPMA) a publi\u00e9 une liste de contr\u00f4le d&#039;auto-inspection r\u00e9vis\u00e9e pour les tests de qualit\u00e9, introduisant un cadre mis \u00e0 jour pour soutenir la fiabilit\u00e9 et la validit\u00e9 scientifique des donn\u00e9es de qualit\u00e9 pharmaceutique soumises dans les demandes de nouveaux m\u00e9dicaments au Japon.\u00a0<\/p>","protected":false},"author":43,"featured_media":9747,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,35,519],"tags":[],"class_list":["post-9746","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-pharma-biotech-latest-insights","category-japan-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.7 (Yoast SEO v28.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Japan Updates JPMA Self-Inspection Checklist for Quality Testing in New Drug Applications<\/title>\n<meta name=\"description\" content=\"Japan\u2019s JPMA has updated its self-inspection checklist for quality testing in new drug applications, integrating analytical and stability testing to improve data reliability.\" \/>\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\/le-japon-met-a-jour-la-liste-de-controle-dauto-inspection-de-la-jpma-pour-les-tests-de-qualite-dans-les-demandes-dautorisation-de-mise-sur-le-marche-de-nouveaux-medicaments\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Japan Updates JPMA Self-Inspection Checklist for Quality Testing in New Drug Applications\" \/>\n<meta property=\"og:description\" content=\"Japan\u2019s JPMA has updated its self-inspection checklist for quality testing in new drug applications, integrating analytical and stability testing to improve data reliability.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/le-japon-met-a-jour-la-liste-de-controle-dauto-inspection-de-la-jpma-pour-les-tests-de-qualite-dans-les-demandes-dautorisation-de-mise-sur-le-marche-de-nouveaux-medicaments\/\" \/>\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=\"2026-04-01T02:27:48+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/04\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications.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=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"Japan Updates JPMA Self-Inspection Checklist for 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