{"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":"indonesiens-bpom-uberarbeitet-die-regeln-fur-die-arzneimittelregistrierung-um-zeitplane-und-kennzeichnung-zu-optimieren","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\/","title":{"rendered":"Indonesien BPOM \u00fcberarbeitet Arzneimittelregistrierungsregeln, um\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\">Ver\u00f6ffentlicht am 19. August 2025 von der\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\">Indonesische Nationale Agentur f\u00fcr Arzneimittel- und Lebensmittelkontrolle (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\">, Die Verordnung Nr. 23 von 2025 f\u00fchrt wesentliche \u00c4nderungen der Kriterien und Verfahren zur Arzneimittelregistrierung ein.<\/span><\/span><span class=\"TextRun SCXW6263149 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW6263149 BCX0\">\u00a0Die Verordnung aktualisiert die Bewertungszeitpl\u00e4ne, pr\u00e4zisiert die Klassifizierung biologischer Produkte und passt die Kennzeichnungsanforderungen an, um sie an internationale Standards anzupassen.<\/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-77937048\">\n\n\t<div id=\"col-1692920224\" 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\">Zusammenfassung des Updates<\/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-1135361970\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1135361970 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">BPOM-Verordnung Nr. 23 von 2025, unterzeichnet am 1. August und g\u00fcltig ab\u00a0<\/span><b><span data-contrast=\"auto\">12. August 2025<\/span><\/b><span data-contrast=\"auto\">, \u00fcberarbeitet die Verordnung Nr. 24 von 2017. Die Aktualisierung konzentriert sich auf drei kritische Bereiche:\u00a0<\/span><b><span data-contrast=\"auto\">Zeitrahmen f\u00fcr die Arzneimittelbewertung<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">Definitionen biologischer Produkte<\/span><\/b><span data-contrast=\"auto\">, Und\u00a0<\/span><b><span data-contrast=\"auto\">Anforderungen an die Arzneimittelkennzeichnung<\/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\">Die Verordnung sieht differenzierte Bewertungszeitr\u00e4ume je nach Produktart und Dringlichkeit vor. Beispielsweise,\u00a0<\/span><b><span data-contrast=\"auto\">Notfallzulassung f\u00fcr Generika<\/span><\/b><span data-contrast=\"auto\">\u00a0erfordert nun nur noch f\u00fcnf Tage \u00dcberpr\u00fcfung, w\u00e4hrend\u00a0<\/span><b><span data-contrast=\"auto\">neue Medikamente gegen lebensbedrohliche Zust\u00e4nde oder seltene Krankheiten\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\">(Arzneimittel f\u00fcr seltene Leiden)<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0wird innerhalb von 100 Tagen ausgewertet.<\/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\">Definitionen von\u00a0<\/span><b><span data-contrast=\"auto\">biologische Produkte<\/span><\/b><span data-contrast=\"auto\">\u00a0wurden erweitert und umfassen nun auch Enzyme, monoklonale Antik\u00f6rper, Hormone, Impfstoffe, Plasmaderivate, rekombinante DNA-Produkte und fortschrittliche Therapien wie\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\">Gentherapie<\/span><\/b><\/a><b><span data-contrast=\"auto\">\u00a0Drogen<\/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\">Kennzeichnungsstandards<\/span><\/b><span data-contrast=\"auto\">\u00a0wurden aktualisiert, um detailliertere Informationen zu verlangen, einschlie\u00dflich Verfallsdaten nach dem \u00d6ffnen oder der Rekonstitution f\u00fcr bestimmte Darreichungsformen wie Augentropfen und gefriergetrocknete Pulver.<\/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\">Die Verordnung verfeinert auch\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW114287126 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114287126 BCX0\">Registrierungswege<\/span><\/span><span class=\"TextRun SCXW114287126 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW114287126 BCX0\">\u00a0f\u00fcr administrative Abweichungen, neue Indikationen oder Dosierungs\u00e4nderungen und den \u00dcbergang von der Notfallzulassung zur vollst\u00e4ndigen Marktzulassung.<\/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-1692920224 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1698081234\" 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\">Feedback-Frist<\/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-862356131\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-862356131 {\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\">Alle bestehenden Arzneimitteletiketten m\u00fcssen aktualisiert werden, um\u00a0<\/span><span class=\"NormalTextRun SCXW158491260 BCX0\">entsprechen<\/span><span class=\"NormalTextRun SCXW158491260 BCX0\">\u00a0die \u00fcberarbeiteten Anforderungen durch\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. August 2027<\/span><\/span><\/strong><span class=\"TextRun SCXW158491260 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW158491260 BCX0\">. Ausnahmen gelten f\u00fcr die Halal-Zertifizierungskennzeichnung, die gesonderten Vorschriften unterliegt.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1698081234 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1416026003\" 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\">Warum es wichtig ist<\/span><\/span><\/h3>\n\t<div id=\"gap-586899394\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-586899394 {\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\">Ziel dieser \u00c4nderungen ist es,\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW88136145 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88136145 BCX0\">den Zugang der Patienten zu wichtigen Therapien zu beschleunigen<\/span><\/span><span class=\"TextRun SCXW88136145 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW88136145 BCX0\">, insbesondere in Notf\u00e4llen oder bei seltenen Erkrankungen, und gleicht gleichzeitig den indonesischen Rechtsrahmen an international anerkannte Systeme an. Durch die Neudefinition von Produktkategorien und die Verfeinerung der Kennzeichnungsanforderungen verbessert BPOM die regulatorische Klarheit und minimiert den Verwaltungsaufwand f\u00fcr die Branche.<\/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-1416026003 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1996032121\" 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\">Wer sollte darauf achten<\/span><\/span><\/h3>\n\t<div id=\"gap-2091829286\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2091829286 {\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\">Dieses Update ist besonders relevant f\u00fcr\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW72162094 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72162094 BCX0\">Regulatory Affairs-Teams, Qualit\u00e4tssicherungsfunktionen, Produktentwicklungsteams und Marktzugangsexperten<\/span><\/span><span class=\"TextRun SCXW72162094 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72162094 BCX0\">\u00a0Verwaltung der Arzneimittelzulassungen in Indonesien. Am st\u00e4rksten betroffen sind Unternehmen, die mit biologischen Produkten und zeitkritischen Zulassungen arbeiten.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1996032121 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1768672021\" 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\">N\u00e4chste Schritte<\/span><\/span><\/h3>\n\t<div id=\"gap-859387222\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-859387222 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die Beteiligten sollten:<\/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\">\u00dcberpr\u00fcfen Sie vorhandene Produktklassifizierungen anhand der erweiterten Definitionen.<\/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\">\u00dcberpr\u00fcfen Sie aktuelle Etiketten, um Aktualisierungen vor Ablauf der Compliance-Frist zu planen.<\/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\">Richten Sie Ihre Regulierungsstrategien an beschleunigten \u00dcberpr\u00fcfungsm\u00f6glichkeiten in Referenzl\u00e4ndern aus, darunter den USA, der EU, Japan, Kanada, Australien, der Schweiz und Gro\u00dfbritannien.<\/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\">Um den sich entwickelnden Anforderungen immer einen Schritt voraus zu sein, sollten Unternehmen Systeme einf\u00fchren, die eine zeitnahe globale \u00dcberwachung der Vorschriften sowie die Dokumentation und das Einreichungsmanagement unterst\u00fctzen.\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\/de\/\"><b><span data-contrast=\"none\">RegASK<\/span><\/b><\/a><b><span data-contrast=\"none\">\u00a0ist eine KI-gesteuerte L\u00f6sung f\u00fcr Regulatory Intelligence und Workflow-Orchestrierung\u00a0<\/span><\/b><span data-contrast=\"none\">Wir helfen Unternehmen aus den Bereichen Biowissenschaften und Konsumg\u00fcter, mit vorausschauenden Erkenntnissen den sich \u00e4ndernden globalen Vorschriften und Richtlinien immer einen Schritt voraus zu sein.\u00a0<\/span><b><span data-contrast=\"none\">Es kombiniert intelligente Dokumentation, automatisierte Workflows und integrierte Experten<\/span><\/b><span data-contrast=\"none\"> um eine schnellere Anpassung zu erm\u00f6glichen, was letztendlich das Betriebsrisiko reduziert.<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1768672021 > .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-1975174422\">\n\n\t<div id=\"col-2112673907\" 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>FAQs<\/h3>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2112673907 > .col-inner {\n  margin: 0px 0px -10px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-131666997\" 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-1196606241\" 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\">Was ist die BPOM-Verordnung Nr. 23 von 2025?<\/span><\/span><\/h4>\n\t\t\n<style>\n#text-1196606241 {\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\">Es handelt sich um eine \u00c4nderung der indonesischen Arzneimittelregistrierungsvorschriften, mit der die Bewertungszeitpl\u00e4ne, Produktdefinitionen und Kennzeichnungsanforderungen mit Wirkung zum 12. August 2025 aktualisiert werden.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-131666997 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1895844099\" 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-2208740037\" 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\">Welche neuen Bewertungszeitr\u00e4ume gelten f\u00fcr die Arzneimittelzulassung?<\/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-2208740037 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW52725570 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW52725570 BCX0\">Die Notfallzulassung f\u00fcr Generika erfolgt nun nach einer f\u00fcnft\u00e4gigen Pr\u00fcfung, w\u00e4hrend neue Orphan- oder lebensbedrohliche Arzneimittel innerhalb von\u00a0<\/span><span class=\"NormalTextRun SCXW52725570 BCX0\">100 Tage<\/span><span class=\"NormalTextRun SCXW52725570 BCX0\">.<\/span><\/span><span class=\"EOP SCXW52725570 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-1895844099 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1919536561\" 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-1856955203\" class=\"text\">\n\t\t\n<h4><span class=\"LineBreakBlob BlobObject DragDrop SCXW30300959 BCX0\"><span class=\"SCXW30300959 BCX0\"><span class=\"NormalTextRun SCXW206806883 BCX0\">Was sind die \u00c4nderungen bei der Kennzeichnung?\u00a0<\/span><span class=\"NormalTextRun SCXW206806883 BCX0\">erforderlich<\/span><span class=\"NormalTextRun SCXW206806883 BCX0\">?<\/span> <\/span><br class=\"SCXW30300959 BCX0\" \/><\/span><\/h4>\n\t\t\n<style>\n#text-1856955203 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW151548071 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW151548071 BCX0\">Etiketten m\u00fcssen nun Angaben enthalten wie\u00a0<\/span><span class=\"NormalTextRun SCXW151548071 BCX0\">Ablauf<\/span><span class=\"NormalTextRun SCXW151548071 BCX0\">\u00a0Daten nach dem \u00d6ffnen oder der Rekonstitution f\u00fcr bestimmte Darreichungsformen wie Augentropfen und gefriergetrocknete Pulver.<\/span><\/span><span class=\"EOP SCXW151548071 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-1919536561 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1566378782\" 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-774862114\" class=\"text\">\n\t\t\n<h4><span class=\"LineBreakBlob BlobObject DragDrop SCXW30300959 BCX0\"><span class=\"NormalTextRun SCXW99105432 BCX0\">Wie kann\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW99105432 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW99105432 BCX0\">\u00a0Unternehmen bei der Einhaltung von BPOM unterst\u00fctzen?<\/span><\/span><\/h4>\n\t\t\n<style>\n#text-774862114 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a class=\"Hyperlink SCXW54028281 BCX0\" href=\"https:\/\/regask.com\/de\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW54028281 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW54028281 BCX0\" data-ccp-charstyle=\"Hyperlink\">RegASK<\/span><\/span><\/a><span class=\"TextRun SCXW54028281 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54028281 BCX0\">\u00a0unterst\u00fctzt Regulierungsteams\u00a0<\/span><span class=\"NormalTextRun SCXW54028281 BCX0\">Monitor<\/span><span class=\"NormalTextRun SCXW54028281 BCX0\">\u00a0Aktualisierungen, optimieren die Dokumentation und stellen sicher\u00a0<\/span><span class=\"NormalTextRun SCXW54028281 BCX0\">rechtzeitig<\/span><span class=\"NormalTextRun SCXW54028281 BCX0\">\u00a0Einhaltung der Kennzeichnungspflicht gem\u00e4\u00df der neuen Verordnung.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1566378782 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Die am 19. August 2025 von der indonesischen Arzneimittel- und Lebensmittelbeh\u00f6rde (BPOM) ver\u00f6ffentlichte Verordnung Nr. 23 von 2025 f\u00fchrt wesentliche \u00c4nderungen der Kriterien und Verfahren f\u00fcr die Arzneimittelzulassung ein. Die Verordnung aktualisiert die Bewertungsfristen, pr\u00e4zisiert die Klassifizierung biologischer Produkte und passt die Kennzeichnungsvorschriften an internationale Standards an.\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. Learn how these changes affect timelines and labeling for medicines.\" \/>\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\/de\/indonesiens-bpom-uberarbeitet-die-regeln-fur-die-arzneimittelregistrierung-um-zeitplane-und-kennzeichnung-zu-optimieren\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Indonesia BPOM Revises Drug Registration Rules to Streamline Timelines and Labeling\" \/>\n<meta property=\"og:description\" content=\"Indonesia&#039;s BPOM has updated drug registration rules. Learn how these changes affect timelines and labeling for medicines.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/indonesiens-bpom-uberarbeitet-die-regeln-fur-die-arzneimittelregistrierung-um-zeitplane-und-kennzeichnung-zu-optimieren\/\" \/>\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=\"2025-09-23T09:28:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/09\/indonesia-bpom-revises-drug-registration-rules-streamline-timelines-labeling.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=\"Hannah Nordin\" \/>\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=\"Hannah Nordin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\\\/\"},\"author\":{\"name\":\"Hannah Nordin\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/3a8aaee2c7585284f97ec9e038e36b65\"},\"headline\":\"Indonesia BPOM Revises Drug Registration Rules to Strea&hellip;\",\"datePublished\":\"2025-09-23T09:28:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\\\/\"},\"wordCount\":710,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/indonesia-bpom-revises-drug-registration-rules-streamline-timelines-labeling.png\",\"articleSection\":[\"Regulatory News\",\"Indonesia\",\"Pharma and Biotech\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\\\/\",\"name\":\"Indonesia BPOM Revises Drug Registration Rules Overview | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/indonesia-bpom-revises-drug-registration-rules-to-streamline-timelines-and-labeling\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/indonesia-bpom-revises-drug-registration-rules-streamline-timelines-labeling.png\",\"datePublished\":\"2025-09-23T09:28:11+00:00\",\"description\":\"Indonesia's BPOM has updated drug registration rules. 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