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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

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Regulatorische Updates
13. Sept. 2026•1 Min. Lesezeit
Movement Headquarters Criticizes Lee Jae‑myung Govt’s 14.4% Health Insurance Treasury Support
The Lee Jae‑myung administration set next year's health‑insurance national treasury support at 14.4%, prompting strong opposition from the anti‑privatization movement, which says it breaks the president’s 20% pledge.
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Regulatorische Updates
13. Sept. 2026•1 Min. Lesezeit
South Korean Government Sets 2027 Health Insurance Treasury Support at 13.8 trillion KRW, Union Claims Effective Cut
The government announced a 13.8 trillion KRW national treasury support for 2027 health insurance, but the Health Insurance Labor Union says the increase is insufficient and amounts to a real reduction.
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Regulatorische Updates
12. Sept. 2026•1 Min. Lesezeit
South Korea widens insurance coverage for rare disease, cancer drugs
South Korea’s Ministry of Health and Welfare announced faster reimbursement for Dravet syndrome treatment Fintepla‑Ac and broader coverage for blood‑cancer and pediatric‑leukemia drugs.
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Regulatorische Updates
12. Sept. 2026•1 Min. Lesezeit
Health Insurance False Claims Detected at 839 Korean Clinics and Pharmacies Over Four Years
839 medical institutions in Korea were found to have submitted false health‑insurance claims totaling 34.79 billion won, with clinics accounting for 42.85% of the amount.
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Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
Korean Merck Healthcare’s Pergoberis® Pen Added to Health Insurance Coverage
Pergoberis® Pen, an infertility treatment, will be reimbursed under Korea’s health insurance from Sep 1, covering all three dosage strengths.
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Regulatorische Updates
10. Sept. 2026•1 Min. Lesezeit
Korean Health Insurance Drug List Shrinks, OTC Items Decline Faster Than Prescription
The number of drugs covered by Korea’s health insurance has fallen steadily, with over‑the‑counter medicines dropping 25.2% over five years—more sharply than prescription drugs.
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Regulatorische Updates
9. Sept. 2026•1 Min. Lesezeit
South Korea to Refund 3.76 trillion won for Out-of-Pocket Caps
Over 2.26 million Koreans who surpassed their personal medical expense caps in 2024 will receive a total of 3.76 trillion won in refunds starting Aug 31, 2025.
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Regulatorische Updates
8. Sept. 2026•1 Min. Lesezeit
Public Petition Calls for Withdrawal of Korea's Remote Drug Delivery Expansion
A Korean citizen petition urges the government to scrap plans to expand non‑face‑to‑face prescription drug delivery, citing health‑insurance strain and safety concerns.
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Regulatorische Updates
7. Sept. 2026•1 Min. Lesezeit
Korea health authorities guide duplicate‑prescription claims for disaster‑area patients
The Ministry of Health and Welfare and HIRA issued instructions for residents of Geoje and Tongyeong special disaster zones to cite a ‘C/’ reason when claiming medical benefits for re‑prescribed medicines lost in heavy rain.
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Regulatorische Updates
7. Sept. 2026•1 Min. Lesezeit
Health Insurance Review & Assessment Service Appoints Prof. Oh Joo-hwan as New Director of Policy Research Institute
HIRA named Prof. Oh Joo-hwan of Seoul National University College of Medicine as director of its Policy Research Institute, effective Sept 1, 2026, highlighting his academic and research experience.
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Regulatorische Updates
7. Sept. 2026•1 Min. Lesezeit
National Health Insurance Ilsan Hospital to Host 2026 Insurer Hospital Policy Forum
The hospital will hold a forum on Sep 3 at Sonocam Goyang to explore new health‑care governance for regional essential services under recent legislation.
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Regulatorische Updates
7. Sept. 2026•1 Min. Lesezeit
HIRA appoints Prof. Oh Joo-hwan as Director of Policy Research Institute
The Health Insurance Review & Assessment Service (HIRA) has appointed Prof. Oh Joo-hwan of Seoul National University College of Medicine as Director of its Policy Research Institute, effective Sept 1.