Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
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Regulatorische Updates
7. Sept. 2026•1 Min. Lesezeit
Health NGOs Oppose Expansion of Telemedicine Prescription Delivery to All Patients
South Korean health‑civil society groups have formally opposed the government’s plan to extend telemedicine prescription delivery to all patients, citing patient safety and health‑insurance cost concerns.
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
Three New Drugs Enter Final Health Insurance Pricing Negotiations in Korea
Medsun Pharma Korea's oxurumoju, SK Biopharm's Excofri, and Korean Janssen's Spravato nasal spray have begun price negotiations for health‑insurance reimbursement, with potential listing after October.
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
85 Korean Drugs Set for Price Reductions Following PVA Negotiations
85 drug items with rising claims or usage are expected to face price cuts or adjustments next month after PVA results with the Health Insurance Review & Assessment Service.
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
Health Insurance Premium Relief and Extra Benefits for Disaster‑Hit Residents in Gyeongbuk and Gyeongnam
Korea Health Insurance Corp announced reduced premiums and additional coverage for lost dentures and disability aids for residents of newly declared special disaster zones.
Regulatorische Updates
5. Sept. 2026•1 Min. Lesezeit
Dongjak‑gu Pharmacy Association Urges Immediate Halt to Expanded Prescription Delivery for Telemedicine
The Dongjak‑gu Pharmacy Association warned that expanding prescription drug delivery for telemedicine could worsen health‑insurance finances and increase drug misuse, calling for an immediate stop.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Dongguk Pharmaceutical's Rosutanmet Tablets Lose Health Insurance Coverage After Approval Cancellation
Two Dongguk Pharmaceutical Rosutanmet tablet products (500/5 mg and 500/10 mg) will have health‑insurance reimbursement stopped from the 28th after the Daejeon regional authority cancelled their approvals.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Kang Cheong-hee appointed Chairman of South Korea's National Health Insurance Service
Kang Cheong-hee, former head of Korea Public Organization Bank, will assume the chairmanship of the National Health Insurance Service on July 20, 2026 for a three‑year term.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Germany Passes Health Insurance Premium Stabilization Law, Seen as Benchmark for Korea
Germany's Bundestag approved a law to stabilize statutory health insurance premiums, expanding high‑income contributors' burden while capping spending on providers and medicines, drawing attention from Korea.
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Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
German Parliament Passes Health‑Insurance Reform Raising Original Drug Discount to 15.5%
The Bundestag approved a reform that lifts the mandatory discount on original medicines from 7% to 15.5%, despite opposition from pharma groups.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Korea Resumes Health Insurance Survey to Crack Down on Pharmacy False Claims
The Ministry of Health and Welfare will conduct a 2026 health‑insurance planning survey (Aug‑Oct) targeting pharmacies with frequent false‑claim types, after a two‑year pause.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Korea Anti-Corruption Commission rules claim period starts from reimbursement decision date
The National Anti‑Corruption and Civil Rights Commission says the limitation period for health‑insurance claims should be calculated from the reimbursement decision date, not the original treatment date, and urges HIRA to issue new guidelines.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Bonofrazan Fumarate Enters Korean Health Insurance Price Negotiations Alongside Original Product
Bonofrazan fumarate, a P‑CAB ulcer medication, has begun price negotiations with Korea’s Health Insurance Review & Assessment Service, drawing industry attention to potential patent and reimbursement impacts.