{"id":8282,"date":"2025-05-27T11:49:40","date_gmt":"2025-05-27T03:49:40","guid":{"rendered":"https:\/\/regask.com\/?p=8282"},"modified":"2025-05-27T11:49:40","modified_gmt":"2025-05-27T03:49:40","slug":"hhs-fda-rfi-unnotige-vorschriften-2025","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/hhs-fda-rfi-unnecessary-regulations-2025\/","title":{"rendered":"Informationsanfrage von HHS und FDA: Identifizierung unn\u00f6tiger \u2026"},"content":{"rendered":"<p data-start=\"162\" data-end=\"576\">Am 13. Mai 2025 ver\u00f6ffentlichten das US-Gesundheitsministerium (HHS) und die US-amerikanische Food and Drug Administration (FDA) eine <strong data-start=\"291\" data-end=\"324\">Informationsanfrage (RFI)<\/strong> um veraltete, doppelte oder unn\u00f6tige Vorschriften zu identifizieren. Dieser Schritt unterst\u00fctzt die umfassenderen Bem\u00fchungen der Bundesregierung, den Regulierungsaufwand zu reduzieren und die Transparenz zu erh\u00f6hen, im Einklang mit <strong data-start=\"504\" data-end=\"575\">Durchf\u00fchrungsverordnung 14192: <em data-start=\"529\" data-end=\"573\">Wohlstand durch Deregulierung freisetzen<\/em><\/strong>.<\/p>\n<h3 data-start=\"578\" data-end=\"609\">Ein mutiges Deregulierungsmandat<\/h3>\n<p data-start=\"611\" data-end=\"971\">Im Rahmen dieser Initiative hat sich HHS-Minister Robert F. Kennedy, Jr. verpflichtet, <strong data-start=\"695\" data-end=\"728\">\u201e10:1\u201c-Deregulierungspolitik<\/strong>\u2014f\u00fcr jede neu eingef\u00fchrte Regelung, <strong data-start=\"766\" data-end=\"782\">mindestens zehn<\/strong> Bestehende Regulierungsma\u00dfnahmen m\u00fcssen aufgehoben werden. Das Ziel: Reduzierung des Compliance-Aufwands, Vereinfachung der Gesundheitsabl\u00e4ufe und F\u00f6rderung von Innovationen unter Wahrung der Sicherheits- und Wirksamkeitsstandards.<\/p>\n<h3 data-start=\"973\" data-end=\"1009\">Schl\u00fcsselkomponenten der Initiative<\/h3>\n<ul data-start=\"1011\" data-end=\"1542\">\n<li data-start=\"1011\" data-end=\"1109\">\n<p data-start=\"1013\" data-end=\"1109\"><strong data-start=\"1013\" data-end=\"1029\">10-zu-1-Regel<\/strong>: F\u00fcr jede neue Regelung m\u00fcssen mindestens zehn bestehende Vorschriften gestrichen werden.<\/p>\n<\/li>\n<li data-start=\"1110\" data-end=\"1226\">\n<p data-start=\"1112\" data-end=\"1226\"><strong data-start=\"1112\" data-end=\"1135\">Regulierungskostendeckel<\/strong>: Die gesamten Nettokosten aller neuen Regelungen im Haushaltsjahr 2025 m\u00fcssen <em data-start=\"1197\" data-end=\"1223\">deutlich unter Null<\/em>.<\/p>\n<\/li>\n<li data-start=\"1227\" data-end=\"1386\">\n<p data-start=\"1229\" data-end=\"1386\"><strong data-start=\"1229\" data-end=\"1247\">Erweiterter Umfang<\/strong>: Die Richtlinie gilt nicht nur f\u00fcr formelle Vorschriften, sondern auch f\u00fcr Leitf\u00e4den, Memoranden, Grundsatzerkl\u00e4rungen und \u00e4hnliche Anweisungen.<\/p>\n<\/li>\n<li data-start=\"1387\" data-end=\"1542\">\n<p data-start=\"1389\" data-end=\"1542\"><strong data-start=\"1389\" data-end=\"1420\">J\u00e4hrliche Transparenzberichte<\/strong>: HHS ver\u00f6ffentlicht j\u00e4hrliche Updates mit detaillierten Angaben dazu, welche Vorschriften ge\u00e4ndert oder entfernt wurden, sowie zu den gesch\u00e4tzten Kosteneinsparungen.<\/p>\n<\/li>\n<\/ul>\n<h3 data-start=\"1544\" data-end=\"1570\">Stakeholder Engagement<\/h3>\n<p data-start=\"1572\" data-end=\"1764\">Die RFI bittet ein breites Spektrum an Interessengruppen \u2013 Unternehmen, Gesundheitsdienstleister und die breite \u00d6ffentlichkeit \u2013 um Beitr\u00e4ge, um bestimmte Vorschriften zu identifizieren, die veraltet oder unn\u00f6tig belastend sind.<\/p>\n<p data-start=\"1766\" data-end=\"2016\">\ud83d\udcc4 <strong data-start=\"1769\" data-end=\"1805\">Hier gelangen Sie zur offiziellen Anfrage<\/strong>:<br data-start=\"1806\" data-end=\"1809\" \/><a class=\"\" href=\"https:\/\/www.federalregister.gov\/documents\/2025\/05\/14\/2025-08384\/request-for-information-rfi-ensuring-lawful-regulation-and-unleashing-innovation-to-make-american\" target=\"_new\" rel=\"noopener\" data-start=\"1809\" data-end=\"2016\">Informationsanfrage \u2013 Bundesregister<\/a><\/p>\n<p data-start=\"2018\" data-end=\"2060\">\ud83d\uddd3\ufe0f <strong data-start=\"2022\" data-end=\"2045\">Einsendeschluss<\/strong>: 12. Juli 2025<\/p>\n<h3 data-start=\"2062\" data-end=\"2106\">Auswirkungen auf die Gesundheitsbranche<\/h3>\n<p data-start=\"2108\" data-end=\"2447\">Dieser Deregulierungsschub k\u00f6nnte zu erheblichen \u00c4nderungen der regulatorischen Anforderungen f\u00fcr verschiedene Gesundheitsprodukte f\u00fchren \u2013 darunter <strong data-start=\"2234\" data-end=\"2285\">Arzneimittel, Medizinprodukte und Biologika<\/strong>Die endg\u00fcltigen Auswirkungen auf Compliance-Strategien, Betriebskosten und Zeitpl\u00e4ne f\u00fcr die Produktzulassung h\u00e4ngen davon ab, welche Vorschriften letztendlich \u00fcberarbeitet oder aufgehoben werden.<\/p>\n<h3 data-start=\"2449\" data-end=\"2476\">N\u00e4chste Schritte f\u00fcr die Industrie<\/h3>\n<p data-start=\"2478\" data-end=\"2613\">Organisationen sollten ihre aktuellen regulatorischen Herausforderungen bewerten und in Erw\u00e4gung ziehen, w\u00e4hrend der \u00f6ffentlichen Konsultationsphase Kommentare einzureichen.<\/p>\n<p data-start=\"2615\" data-end=\"2757\">\ud83d\udc49 <strong data-start=\"2618\" data-end=\"2757\">Bitten Sie RegASK, die Aktualisierungen des HHS zu \u00fcberwachen und an relevanten Konsultationen teilzunehmen, um \u00fcber bevorstehende regulatorische \u00c4nderungen auf dem Laufenden zu bleiben.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Am 13. Mai 2025 ver\u00f6ffentlichten das US-Gesundheitsministerium (HHS) und die US-Arzneimittelbeh\u00f6rde (FDA) eine Informationsanfrage (RFI), um veraltete, doppelte oder unn\u00f6tige Vorschriften zu ermitteln. Dieser Schritt unterst\u00fctzt die umfassenderen Bem\u00fchungen der Bundesregierung, den Regulierungsaufwand zu reduzieren und die Transparenz zu erh\u00f6hen, gem\u00e4\u00df der Executive Order 14192: \u201eUnleashing\u2026\u201c<\/p>","protected":false},"author":43,"featured_media":8298,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,35],"tags":[629],"class_list":["post-8282","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-biotech-latest-insights","tag-request-for-information"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>HHS and FDA Request for Information: Identifying Unnecessary Regulations | RegASK<\/title>\n<meta name=\"description\" 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