{"id":9660,"date":"2026-03-18T06:14:17","date_gmt":"2026-03-17T22:14:17","guid":{"rendered":"https:\/\/regask.com\/?p=9660"},"modified":"2026-03-18T06:14:17","modified_gmt":"2026-03-17T22:14:17","slug":"lautorite-chilienne-de-securite-interieure-isp-introduit-un-cadre-reglementaire-de-confiance-pour-les-inspections-des-bpf-pharmaceutiques","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/chile-isp-introduces-regulatory-reliance-framework-for-pharmaceutical-gmp-inspections\/","title":{"rendered":"Un fournisseur d&#039;acc\u00e8s Internet chilien introduit un cadre de d\u00e9pendance r\u00e9glementaire pour\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">Sur\u00a0<\/span><b><span data-contrast=\"auto\">9 mars 2026<\/span><\/b><span data-contrast=\"auto\">, le\u00a0<\/span><b><span data-contrast=\"auto\">Institut de sant\u00e9 publique du Chili (ISP)<\/span><\/b><span data-contrast=\"auto\">\u00a0a publi\u00e9 une r\u00e9solution introduisant des orientations sur\u00a0<\/span><b><span data-contrast=\"auto\">m\u00e9canismes de r\u00e9gulation des inspections pharmaceutiques<\/span><\/b><span data-contrast=\"auto\">. La r\u00e9solution, qui est entr\u00e9e en vigueur le\u00a0<\/span><b><span data-contrast=\"auto\">28 janvier 2026<\/span><\/b><span data-contrast=\"auto\">, \u00e9tablit un cadre permettant aux autorit\u00e9s de r\u00e9glementation chiliennes de s&#039;appuyer sur les conclusions d&#039;inspections men\u00e9es par des autorit\u00e9s internationales reconnues lors de l&#039;\u00e9valuation\u00a0<\/span><b><span data-contrast=\"auto\">Bonnes pratiques de fabrication (BPF)<\/span><\/b><span data-contrast=\"auto\">\u00a0conformit\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\">La mise \u00e0 jour s&#039;applique aux deux\u00a0<\/span><b><span data-contrast=\"auto\">produits pharmaceutiques nationaux et import\u00e9s<\/span><\/b><span data-contrast=\"auto\">\u00a0et affecte\u00a0<\/span><b><span data-contrast=\"auto\">fabricants, titulaires d&#039;autorisation de mise sur le march\u00e9 et organisations impliqu\u00e9es dans la production, la distribution et le stockage<\/span><\/b><span data-contrast=\"auto\">.L\u2019objectif est de renforcer le contr\u00f4le des bonnes pratiques pharmaceutiques tout en am\u00e9liorant l\u2019efficacit\u00e9 des processus d\u2019inspection.<\/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-1652143563\">\n\n\t<div id=\"col-1771175885\" 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-918913136\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-918913136 {\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-1809368617\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1809368617 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Conform\u00e9ment \u00e0 ces nouvelles directives, l&#039;ISP introduit un m\u00e9canisme de confiance structur\u00e9 qui permet aux rapports d&#039;inspection \u00e9mis par des autorit\u00e9s internationales reconnues de servir de base \u00e0 la v\u00e9rification r\u00e9glementaire au Chili.<\/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\">rapports d&#039;inspection d&#039;organismes reconnus par\u00a0<\/span><b><span data-contrast=\"auto\">OPS\/OMS ou le Syst\u00e8me de coop\u00e9ration en mati\u00e8re d&#039;inspection pharmaceutique (PIC\/S)<\/span><\/b><span data-contrast=\"auto\">\u00a0peuvent \u00eatre utilis\u00e9s par les autorit\u00e9s chiliennes pour v\u00e9rifier\u00a0<\/span><b><span data-contrast=\"auto\">Conformit\u00e9 aux BPF pour les fabricants pharmaceutiques \u00e9trangers<\/span><\/b><span data-contrast=\"auto\">. Ces rapports peuvent appuyer les \u00e9valuations r\u00e9glementaires relatives aux conditions de fabrication et aux 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\">Les directives introduisent \u00e9galement\u00a0<\/span><b><span data-contrast=\"auto\">surveillance fond\u00e9e sur les risques<\/span><\/b><span data-contrast=\"auto\">\u00a0Ces conclusions, issues d&#039;inspections r\u00e9glementaires \u00e9trang\u00e8res, peuvent influencer les d\u00e9cisions r\u00e9glementaires ayant une incidence sur ces d\u00e9cisions.\u00a0<\/span><b><span data-contrast=\"auto\">produits pharmaceutiques import\u00e9s et leurs titulaires d&#039;enregistrement<\/span><\/b><span data-contrast=\"auto\">, y compris les activit\u00e9s de v\u00e9rification de la conformit\u00e9 et de contr\u00f4le.<\/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, le m\u00e9canisme prend en charge\u00a0<\/span><b><span data-contrast=\"auto\">priorisation annuelle des inspections des usines de fabrication \u00e9trang\u00e8res<\/span><\/b><span data-contrast=\"auto\">\u00a0Ce dispositif concerne les produits pharmaceutiques entrant sur le march\u00e9 chilien. En s&#039;appuyant sur les r\u00e9sultats d&#039;inspections men\u00e9es par des organismes de r\u00e9glementation internationaux reconnus, le SPI vise \u00e0 optimiser l&#039;allocation des ressources d&#039;inspection tout en maintenant des normes de qualit\u00e9 \u00e9lev\u00e9es.<\/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\">Pour soutenir ce cadre, les parties prenantes doivent veiller \u00e0 ce que\u00a0<\/span><b><span data-contrast=\"auto\">documentation d&#039;inspection d\u00e9livr\u00e9e par les autorit\u00e9s r\u00e9glementaires reconnues<\/span><\/b><span data-contrast=\"auto\">\u00a0Ces documents sont disponibles pour consultation \u00e0 la demande de l&#039;autorit\u00e9 de r\u00e9glementation chilienne. Ils peuvent \u00eatre exig\u00e9s lors d&#039;\u00e9valuations r\u00e9glementaires ou de contr\u00f4les de conformit\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\">Globalement, les recommandations favorisent\u00a0<\/span><b><span data-contrast=\"auto\">normes de qualit\u00e9 harmonis\u00e9es chez les fournisseurs pharmaceutiques nationaux et internationaux<\/span><\/b><span data-contrast=\"auto\">\u00a0op\u00e9rant sous la supervision r\u00e9glementaire du Chili.<\/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-1771175885 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-589534285\" 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 d&#039;entr\u00e9e en vigueur<\/h2>\n\t<div id=\"gap-2011667101\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2011667101 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW148914550 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW148914550 BCX0\">La r\u00e9solution\u00a0<\/span><span class=\"NormalTextRun SCXW148914550 BCX0\">\u00e9tablissement<\/span><span class=\"NormalTextRun SCXW148914550 BCX0\">\u00a0m\u00e9canismes de d\u00e9pendance r\u00e9glementaire pour le\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW148914550 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW148914550 BCX0\">Sous-d\u00e9partement des inspections au sein de l&#039;Agence nationale des m\u00e9dicaments <\/span><\/span><\/strong><span class=\"TextRun SCXW148914550 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW148914550 BCX0\">est entr\u00e9 en vigueur le <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW148914550 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW148914550 BCX0\">28 janvier 2026<\/span><\/span><span class=\"TextRun SCXW148914550 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW148914550 BCX0\">.<\/span><\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-589534285 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-174064079\" 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-6616578\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-6616578 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>L&#039;introduction de m\u00e9canismes de r\u00e9gulation soutient<strong> Harmonisation r\u00e9glementaire et efficacit\u00e9 des inspections pharmaceutiques.<\/strong> En prenant en compte les conclusions des inspections men\u00e9es par des organismes de r\u00e9glementation internationaux reconnus, le FAI peut am\u00e9liorer <strong>surveillance fond\u00e9e sur les risques,<\/strong> r\u00e9duire les activit\u00e9s d&#039;inspection redondantes et maintenir la surveillance de <strong>Conformit\u00e9 aux BPF<\/strong> pour les produits entrant sur le march\u00e9 chilien tout en minimisant les charges administratives.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-174064079 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1430443333\" 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-618882486\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-618882486 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est pertinente pour <strong>fabricants de produits pharmaceutiques, titulaires d&#039;autorisation de mise sur le march\u00e9, \u00e9quipes des affaires r\u00e9glementaires, professionnels de l&#039;assurance qualit\u00e9 et acteurs de la cha\u00eene d&#039;approvisionnement<\/strong> impliqu\u00e9s dans la production, l&#039;importation, la distribution et le stockage de produits m\u00e9dicinaux destin\u00e9s au march\u00e9 chilien.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1430443333 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1925109391\" 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-1682215560\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1682215560 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les parties prenantes devraient\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9valuer les proc\u00e9dures actuelles de pr\u00e9paration aux inspections et de conformit\u00e9 interne<\/span><\/b><span data-contrast=\"auto\">\u00a0afin de garantir la conformit\u00e9 avec les m\u00e9canismes de d\u00e9pendance nouvellement \u00e9tablis. Les organisations doivent \u00e9galement v\u00e9rifier que\u00a0<\/span><b><span data-contrast=\"auto\">rapports d&#039;inspection et documents justificatifs \u00e9manant d&#039;autorit\u00e9s internationales reconnues<\/span><\/b><span data-contrast=\"auto\">\u00a0sont facilement disponibles pour un examen r\u00e9glementaire sur demande.<\/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 sont encourag\u00e9es \u00e0 consulter l&#039;int\u00e9gralit\u00e9 de la r\u00e9solution publi\u00e9e par\u00a0<\/span><b><span data-contrast=\"auto\">Institut de sant\u00e9 publique du Chili (ISP)<\/span><\/b><span data-contrast=\"auto\">\u00a0comprendre les attentes d\u00e9taill\u00e9es en mati\u00e8re de documentation et de supervision des inspections.<\/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\">Alors que les autorit\u00e9s r\u00e9glementaires adoptent de plus en plus de m\u00e9canismes de confiance et de cadres de coop\u00e9ration internationale, il est essentiel de maintenir la visibilit\u00e9 sur\u00a0<\/span><b><span data-contrast=\"auto\">r\u00e9sultats des inspections et exigences de conformit\u00e9 transfrontali\u00e8res<\/span><\/b><span data-contrast=\"auto\">\u00a0devient crucial pour les op\u00e9rations pharmaceutiques mondiales.<\/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 mondiales op\u00e9rant dans 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,\u00a0<a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a>\u00a0<\/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.\u00a0<\/span><b><span data-contrast=\"auto\"><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><\/span><\/b><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-1925109391 > .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-505211873\">\n\n\t<div id=\"col-342997200\" 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-11255762\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-11255762 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW192215078 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW192215078 BCX0\" data-ccp-parastyle=\"heading 3\">Quel changement r\u00e9glementaire le service de police chilien a-t-il introduit concernant les inspections pharmaceutiques\u00a0?<\/span><\/span><span class=\"EOP SCXW192215078 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-1600865498\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1600865498 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Le<strong> Institut de sant\u00e9 publique du Chili (ISP)<\/strong> introduction de lignes directrices \u00e9tablissant <strong>m\u00e9canismes de d\u00e9pendance r\u00e9glementaire,<\/strong> permettre aux autorit\u00e9s chiliennes d&#039;utiliser les conclusions d&#039;inspections men\u00e9es par des organismes de r\u00e9glementation internationaux reconnus pour appuyer la surveillance de <strong>Bonnes pratiques de fabrication (BPF). <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-342997200 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-800112817\" 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 SCXW186654781 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW186654781 BCX0\" data-ccp-parastyle=\"heading 3\">Quelles sont les autorit\u00e9s d&#039;inspection internationales reconnues dans le cadre de ces directives\u00a0?<\/span><\/span><span class=\"EOP SCXW186654781 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-659206064\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-659206064 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW72249622 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72249622 BCX0\">Rapports d&#039;inspection des agences r\u00e9pertori\u00e9es par\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW72249622 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72249622 BCX0\">OPS\/OMS<\/span><\/span><\/strong><span class=\"TextRun SCXW72249622 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72249622 BCX0\">\u00a0ou membres de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW72249622 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72249622 BCX0\">Programme de coop\u00e9ration en mati\u00e8re d&#039;inspection pharmaceutique (PIC\/S)<\/span><\/span><\/strong><span class=\"TextRun SCXW72249622 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72249622 BCX0\"><strong>\u00a0<\/strong>peut \u00eatre utilis\u00e9 pour appuyer la v\u00e9rification de la conformit\u00e9 aux BPF des fabricants pharmaceutiques \u00e9trangers.<\/span><\/span><span class=\"EOP SCXW72249622 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-800112817 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1730415682\" 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 SCXW114474107 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW114474107 BCX0\" data-ccp-parastyle=\"heading 3\">Qui est concern\u00e9 par le nouveau cadre r\u00e9glementaire de d\u00e9pendance au Chili ?<\/span><\/span><span class=\"EOP SCXW114474107 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-268685924\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-268685924 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW268415581 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW268415581 BCX0\">Les directives ont une incidence\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW268415581 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW268415581 BCX0\">fabricants de produits pharmaceutiques, titulaires d&#039;autorisation de mise sur le march\u00e9 et organismes impliqu\u00e9s dans la production, la distribution et le stockage de m\u00e9dicaments<\/span><\/span><\/strong><span class=\"TextRun SCXW268415581 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW268415581 BCX0\"><strong>\u00a0<\/strong>approvisionn\u00e9 le march\u00e9 chilien.<\/span><\/span><span class=\"EOP SCXW268415581 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-1730415682 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-35613101\" 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 SCXW82391252 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW82391252 BCX0\" data-ccp-parastyle=\"heading 3\">Comment peut-on\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW82391252 BCX0\" data-ccp-parastyle=\"heading 3\">RegASK<\/span><span class=\"NormalTextRun SCXW82391252 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0aider les entreprises \u00e0 s&#039;adapter \u00e0 l&#039;\u00e9volution des cadres d&#039;inspection et de r\u00e9glementation ?<\/span><\/span><span class=\"EOP SCXW82391252 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-2062433420\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2062433420 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW85818566 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/fr\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW85818566 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW85818566 BCX0\">\u00a0aide les organisations\u00a0<\/span><span class=\"NormalTextRun SCXW85818566 BCX0\">moniteur<\/span><span class=\"NormalTextRun SCXW85818566 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW85818566 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW85818566 BCX0\">mises \u00e0 jour r\u00e9glementaires mondiales, cadres d&#039;inspection et exigences de conformit\u00e9<\/span><\/span><\/strong><span class=\"TextRun SCXW85818566 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW85818566 BCX0\">\u00a0\u00e0 travers plusieurs\u00a0<\/span><span class=\"NormalTextRun SCXW85818566 BCX0\">juridictions<\/span><span class=\"NormalTextRun SCXW85818566 BCX0\">. \u00c0 travers\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW85818566 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW85818566 BCX0\">Intelligence r\u00e9glementaire et automatisation des flux de travail pilot\u00e9es par l&#039;IA<\/span><\/span><\/strong><span class=\"TextRun SCXW85818566 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW85818566 BCX0\"><strong>,<\/strong> La plateforme aide les \u00e9quipes r\u00e9glementaires et qualit\u00e9 \u00e0 rester align\u00e9es sur l&#039;\u00e9volution des m\u00e9canismes de surveillance tels que les initiatives de d\u00e9pendance r\u00e9glementaire.<\/span><\/span><span class=\"EOP SCXW85818566 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-35613101 > .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 9 mars 2026, l\u2019Institut chilien de sant\u00e9 publique (ISP) a publi\u00e9 une r\u00e9solution \u00e9tablissant des lignes directrices sur les m\u00e9canismes de recours r\u00e9glementaire pour les inspections pharmaceutiques. Cette r\u00e9solution, entr\u00e9e en vigueur le 28 janvier 2026, instaure un cadre permettant aux autorit\u00e9s r\u00e9glementaires chiliennes de s\u2019appuyer sur les conclusions d\u2019inspections men\u00e9es par des autorit\u00e9s internationales reconnues pour \u00e9valuer la conformit\u00e9 aux bonnes pratiques de fabrication (BPF). Cette mise \u00e0 jour s\u2019applique aux produits pharmaceutiques nationaux et import\u00e9s.<\/p>","protected":false},"author":43,"featured_media":9661,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,564,35],"tags":[],"class_list":["post-9660","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-chile-regulations","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Chile ISP Introduces Regulatory Reliance Framework<\/title>\n<meta name=\"description\" content=\"Learn about the Chile ISP&#039;s new regulatory reliance framework for pharmaceutical GMP inspections enhancing efficiency and compliance.\" \/>\n<meta name=\"robots\" content=\"index, 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