{"id":8712,"date":"2025-09-23T17:28:11","date_gmt":"2025-09-23T09:28:11","guid":{"rendered":"https:\/\/regask.com\/?p=8712"},"modified":"2025-09-23T17:28:11","modified_gmt":"2025-09-23T09:28:11","slug":"lagence-indonesienne-de-gestion-des-medicaments-bpo-revise-ses-regles-denregistrement-des-medicaments-afin-de-simplifier-les-delais-et-letiquetage","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\/","title":{"rendered":"Le BPOM indon\u00e9sien r\u00e9vise les r\u00e8gles d&#039;enregistrement des m\u00e9dicaments pour diffuser\u2026"},"content":{"rendered":"<p><span class=\"TextRun MacChromeBold SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW6263149 BCX0\">Publi\u00e9 le 19 ao\u00fbt 2025 par le\u00a0<\/span><\/span><a class=\"Hyperlink SCXW6263149 BCX0\" href=\"https:\/\/www.pom.go.id\/#:~:text=Beranda,Badan%20Pengawas%20Obat%20dan%20Makanan\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined MacChromeBold SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW6263149 BCX0\" data-ccp-charstyle=\"Hyperlink\">Agence nationale indon\u00e9sienne de contr\u00f4le des m\u00e9dicaments et des aliments (BPOM)<\/span><\/span><\/a><span class=\"TextRun MacChromeBold SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW6263149 BCX0\">Le r\u00e8glement n\u00b0 23 de 2025 introduit des modifications majeures aux crit\u00e8res et proc\u00e9dures d\u2019enregistrement des m\u00e9dicaments.<\/span><\/span><span class=\"TextRun SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW6263149 BCX0\">\u00a0Le r\u00e8glement met \u00e0 jour les d\u00e9lais d\u2019\u00e9valuation, clarifie les classifications des produits biologiques et ajuste les exigences d\u2019\u00e9tiquetage pour les aligner sur les normes internationales.<\/span><\/span><span class=\"EOP SCXW6263149 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-1576785672\">\n\n\t<div id=\"col-291034717\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW242349405 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW242349405 BCX0\" data-ccp-parastyle=\"heading 2\">R\u00e9sum\u00e9 de la mise \u00e0 jour<\/span><\/span><span class=\"EOP SCXW242349405 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-2128236256\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2128236256 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">R\u00e8glement BPOM n\u00b0 23 de 2025, sign\u00e9 le 1er ao\u00fbt et en vigueur \u00e0 compter du\u00a0<\/span><b><span data-contrast=\"auto\">12 ao\u00fbt 2025<\/span><\/b><span data-contrast=\"auto\">, r\u00e9vise le r\u00e8glement n\u00b0 24 de 2017. La mise \u00e0 jour se concentre sur trois domaines critiques :\u00a0<\/span><b><span data-contrast=\"auto\">d\u00e9lais d&#039;\u00e9valuation des m\u00e9dicaments<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">d\u00e9finitions des produits biologiques<\/span><\/b><span data-contrast=\"auto\">, et\u00a0<\/span><b><span data-contrast=\"auto\">exigences en mati\u00e8re d&#039;\u00e9tiquetage des m\u00e9dicaments<\/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 r\u00e8glement \u00e9tablit des d\u00e9lais d&#039;\u00e9valuation diff\u00e9renci\u00e9s selon le type de produit et son urgence. Par exemple\u00a0:\u00a0<\/span><b><span data-contrast=\"auto\">autorisation d&#039;utilisation d&#039;urgence pour les m\u00e9dicaments g\u00e9n\u00e9riques<\/span><\/b><span data-contrast=\"auto\">\u00a0ne n\u00e9cessite d\u00e9sormais que cinq jours d&#039;examen, tandis que\u00a0<\/span><b><span data-contrast=\"auto\">de nouveaux m\u00e9dicaments pour traiter des maladies potentiellement mortelles ou des maladies rares\u00a0<\/span><\/b><a href=\"https:\/\/www.fda.gov\/industry\/medical-products-rare-diseases-and-conditions\/designating-orphan-product-drugs-and-biological-products\"><b><span data-contrast=\"none\">(M\u00e9dicaments orphelins)<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0sera \u00e9valu\u00e9 dans les 100 jours.<\/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\">D\u00e9finitions de\u00a0<\/span><b><span data-contrast=\"auto\">produits biologiques<\/span><\/b><span data-contrast=\"auto\">\u00a0ont \u00e9t\u00e9 \u00e9largis pour inclure des enzymes, des anticorps monoclonaux, des hormones, des vaccins, des d\u00e9riv\u00e9s du plasma, des produits d&#039;ADN recombinant et des th\u00e9rapies avanc\u00e9es telles que\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/what-gene-therapy#:~:text=Gene%20therapy%20products%20are%20being,therapeutic%20genes%20into%20human%20cells.\"><b><span data-contrast=\"none\">th\u00e9rapie g\u00e9nique<\/span><\/b><\/a><b><span data-contrast=\"auto\">\u00a0drogues<\/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><b><span data-contrast=\"auto\">Normes d&#039;\u00e9tiquetage<\/span><\/b><span data-contrast=\"auto\">\u00a0ont \u00e9t\u00e9 mis \u00e0 jour pour exiger des informations plus d\u00e9taill\u00e9es, y compris les dates d&#039;expiration apr\u00e8s ouverture ou reconstitution pour des formes posologiques sp\u00e9cifiques telles que les gouttes ophtalmiques et les poudres lyophilis\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 class=\"TextRun SCXW114287126 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114287126 BCX0\">Le r\u00e8glement pr\u00e9cise \u00e9galement\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW114287126 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114287126 BCX0\">voies d&#039;inscription<\/span><\/span><span class=\"TextRun SCXW114287126 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114287126 BCX0\">\u00a0pour les variations administratives, les nouvelles indications ou les changements de posologie, et la transition de l\u2019autorisation d\u2019utilisation d\u2019urgence \u00e0 l\u2019approbation compl\u00e8te de la mise sur le march\u00e9.<\/span><\/span><span class=\"EOP SCXW114287126 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-291034717 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1363197097\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW244547784 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW244547784 BCX0\" data-ccp-parastyle=\"heading 2\">Date limite de retour d&#039;information<\/span><\/span><span class=\"EOP SCXW244547784 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-1466201667\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1466201667 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW158491260 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW158491260 BCX0\">Toutes les \u00e9tiquettes de m\u00e9dicaments existantes doivent \u00eatre mises \u00e0 jour pour\u00a0<\/span><span class=\"NormalTextRun SCXW158491260 BCX0\">se conformer \u00e0<\/span><span class=\"NormalTextRun SCXW158491260 BCX0\">\u00a0les exigences r\u00e9vis\u00e9es par\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW158491260 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW158491260 BCX0\">12 ao\u00fbt 2027<\/span><\/span><\/strong><span class=\"TextRun SCXW158491260 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW158491260 BCX0\">Des exceptions s\u2019appliquent \u00e0 l\u2019\u00e9tiquetage de certification halal, qui est g\u00e9r\u00e9 par des r\u00e9glementations distinctes.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1363197097 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1032598355\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW213342177 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW213342177 BCX0\" data-ccp-parastyle=\"heading 2\">Pourquoi c&#039;est important<\/span><\/span><\/h3>\n\t<div id=\"gap-1380850200\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1380850200 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW88136145 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88136145 BCX0\">Ces amendements visent \u00e0\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW88136145 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88136145 BCX0\">acc\u00e9l\u00e9rer l&#039;acc\u00e8s des patients aux th\u00e9rapies essentielles<\/span><\/span><span class=\"TextRun SCXW88136145 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88136145 BCX0\">, notamment dans les situations d&#039;urgence ou de maladies rares, tout en alignant le cadre r\u00e9glementaire indon\u00e9sien sur les syst\u00e8mes reconnus internationalement. En red\u00e9finissant les cat\u00e9gories de produits et en affinant les exigences d&#039;\u00e9tiquetage, le BPOM am\u00e9liore la clart\u00e9 r\u00e9glementaire et minimise la charge administrative pour le secteur.<\/span><\/span><span class=\"EOP SCXW88136145 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-1032598355 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1349720920\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW203674993 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW203674993 BCX0\" data-ccp-parastyle=\"heading 2\">Qui devrait en prendre note<\/span><\/span><\/h3>\n\t<div id=\"gap-1378397313\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1378397313 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW72162094 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72162094 BCX0\">Cette mise \u00e0 jour est particuli\u00e8rement pertinente pour\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW72162094 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72162094 BCX0\">\u00e9quipes des affaires r\u00e9glementaires, fonctions d&#039;assurance qualit\u00e9, \u00e9quipes de d\u00e9veloppement de produits et professionnels de l&#039;acc\u00e8s au march\u00e9<\/span><\/span><span class=\"TextRun SCXW72162094 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72162094 BCX0\">\u00a0Gestion des enregistrements de m\u00e9dicaments en Indon\u00e9sie. Les entreprises qui traitent des produits biologiques et dont les approbations sont urgentes seront les plus touch\u00e9es.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1349720920 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-382082308\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW133163949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW133163949 BCX0\" data-ccp-parastyle=\"heading 2\">Prochaines \u00e9tapes<\/span><\/span><\/h3>\n\t<div id=\"gap-644064857\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-644064857 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les parties prenantes devraient :<\/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<ul>\n<li><span data-contrast=\"auto\">Examiner les classifications de produits existantes par rapport aux d\u00e9finitions \u00e9largies.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Auditez les \u00e9tiquettes actuelles pour planifier les mises \u00e0 jour avant la date limite 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><\/li>\n<li><span data-contrast=\"auto\">Alignez les strat\u00e9gies r\u00e9glementaires avec les opportunit\u00e9s d\u2019examen acc\u00e9l\u00e9r\u00e9 dans les pays de r\u00e9f\u00e9rence, notamment les \u00c9tats-Unis, l\u2019UE, le Japon, le Canada, l\u2019Australie, la Suisse et le Royaume-Uni.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Pour rester en avance sur l\u2019\u00e9volution des exigences, les entreprises doivent adopter des syst\u00e8mes qui prennent en charge la surveillance r\u00e9glementaire mondiale, la documentation et la gestion des soumissions en temps opportun.\u00a0<\/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><a href=\"https:\/\/regask.com\/fr\/\"><b><span data-contrast=\"none\">RegASK<\/span><\/b><\/a><b><span data-contrast=\"none\">\u00a0est une solution bas\u00e9e sur l&#039;IA pour l&#039;intelligence r\u00e9glementaire et l&#039;orchestration des flux de travail\u00a0<\/span><\/b><span data-contrast=\"none\">aider les entreprises du secteur des sciences de la vie et des biens de consommation emball\u00e9s \u00e0 garder une longueur d&#039;avance sur l&#039;\u00e9volution des r\u00e9glementations et des directives mondiales gr\u00e2ce \u00e0 des informations pr\u00e9dictives.\u00a0<\/span><b><span data-contrast=\"none\">Il combine une documentation intelligente, des flux de travail automatis\u00e9s et des experts int\u00e9gr\u00e9s<\/span><\/b><span data-contrast=\"none\"> pour permettre une adaptation plus rapide, ce qui r\u00e9duit en fin de compte le risque op\u00e9rationnel.<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-382082308 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<div class=\"row\"  id=\"row-418197725\">\n\n\t<div id=\"col-777583105\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>FAQ<\/h3>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-777583105 > .col-inner {\n  margin: 0px 0px -10px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-211923833\" 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=\"text-1835708764\" class=\"text\">\n\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW204898813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW204898813 BCX0\">Qu&#039;est-ce que le r\u00e8glement BPOM n\u00b0 23 de 2025 ?<\/span><\/span><\/h4>\n\t\t\n<style>\n#text-1835708764 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW204898813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW204898813 BCX0\">Il s&#039;agit d&#039;un amendement aux r\u00e8gles d&#039;enregistrement des m\u00e9dicaments en Indon\u00e9sie, mettant \u00e0 jour les d\u00e9lais d&#039;\u00e9valuation, les d\u00e9finitions de produits et les exigences d&#039;\u00e9tiquetage, en vigueur \u00e0 compter du 12 ao\u00fbt 2025.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-211923833 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1918187689\" 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=\"text-1540336402\" class=\"text\">\n\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW30300959 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW30300959 BCX0\">Quels sont les nouveaux d\u00e9lais d\u2019\u00e9valuation pour l\u2019enregistrement des m\u00e9dicaments ?<\/span><\/span><span class=\"LineBreakBlob BlobObject DragDrop SCXW30300959 BCX0\"><span class=\"SCXW30300959 BCX0\">\u00a0<\/span><br class=\"SCXW30300959 BCX0\" \/><\/span><\/h4>\n\t\t\n<style>\n#text-1540336402 {\n  line-height: 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l&#039;\u00e9tiquetage dans le cadre de la nouvelle r\u00e9glementation.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-937223316 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Publi\u00e9 le 19 ao\u00fbt 2025 par l&#039;Agence nationale indon\u00e9sienne de contr\u00f4le des m\u00e9dicaments et des aliments (BPOM), le r\u00e8glement n\u00b0 23 de 2025 apporte des modifications majeures aux crit\u00e8res et proc\u00e9dures d&#039;enregistrement des m\u00e9dicaments. Il actualise les d\u00e9lais d&#039;\u00e9valuation, clarifie la classification des produits biologiques et adapte les exigences d&#039;\u00e9tiquetage aux normes internationales.\u00a0<\/p>","protected":false},"author":32,"featured_media":8713,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,517,35],"tags":[],"class_list":["post-8712","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-indonesia-regulations","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>Indonesia BPOM Revises Drug Registration Rules Overview | RegASK<\/title>\n<meta name=\"description\" content=\"Indonesia&#039;s BPOM has updated drug registration rules. 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