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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

UPDATED
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.
UPDATED
Regulatorische Updates
7. Sept. 2026•1 Min. Lesezeit
Over 60% of Korean Regions Lack Pediatric Palliative Care Support Institutions
A KPA News report reveals that 10 of 16 Korean provinces have no institutions delivering pediatric and adolescent palliative care under the Ministry’s support program.
UPDATED
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.
UPDATED
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
Korea CDC Launches Nationwide Hairy Tick Surveillance for Autumn Season
The Korea Disease Control and Prevention Agency will surveil hairy tick occurrences at 18 locations from Aug 26 to Dec 16 to curb Tsutsugamushi disease spread.
UPDATED
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
Chungbuk Pharmacists and Students Protest for Clear Han‑Yak‑Sa Licensing
Pharmacists and pharmacy students from Chungbuk joined a relay protest at the presidential office, demanding the government clarify licensing scopes for pharmacists and han‑yak‑sa and resolve longstanding issues.
UPDATED
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
Roche and Eli Lilly's Elecsys pTau217 Blood Test Receives FDA Approval
Roche and Eli Lilly's Elecsys pTau217 blood test for Alzheimer’s received FDA clearance, measuring phosphorylated tau 217 to aid diagnosis and exclusion.
UPDATED
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
EU Approves Gilead's Trodelvy with Merck's Keytruda for PD‑L1‑Positive Triple‑Negative Breast Cancer
The European Commission has authorized the use of Gilead’s ADC Trodelvy in combination with Merck’s Keytruda for patients with PD‑L1‑positive triple‑negative breast cancer that is unresectable, locally advanced or metastatic.
UPDATED
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.
UPDATED
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.
UPDATED
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
Korean Pharmacy Accused of Compounding Rx Drugs Without Pharmacist
The Korean Pharmaceutical Association reported that a pharmacy run by a 한약사 was compounding and selling prescription medicines without employing a licensed pharmacist, prompting a complaint to local health authorities.
UPDATED
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
Seoul Pharmacists Association Calls for Emergency Assembly Over Expanded Telemedicine Drug Delivery
The Seoul Pharmacists Association urged the Korean Pharmacists Association to convene an emergency delegate assembly to formulate a unified response to the proposed expansion of non‑face‑to‑face prescription drug delivery.
UPDATED
Regulatorische Updates
6. Sept. 2026•1 Min. Lesezeit
Democratic Party policy chief cautions against premature expansion of telemedicine drug delivery in Korea
Policy chief Jo Won‑jun warns that expanding drug delivery via telemedicine before proper implementation is premature, citing concerns after the DoctorNow Prevention Act passed.