규제 업데이트
FDA, EMA, TGA 및 글로벌 규제 동향
규제 업데이트
2026년 9월 20일•1분 읽기
KPA Refutes Remote‑Care Claim of 23.4% Medication Delivery Failure
The Korean Pharmaceutical Association rejected the remote‑medicine industry's claim that 23.4% of patients missed medication due to delivery limits, citing official health‑insurance data showing dispensing rates of 95.6% in June 2023 and 92.1% in Dec 2025.
규제 업데이트
2026년 9월 20일•1분 읽기
Korean Health Insurance Union Opposes 2027 Premium Rate Freeze
The National Health Insurance Labor Union criticized the government's decision to keep the 2027 health insurance contribution rate unchanged, warning it could accelerate financial deterioration amid rising medical demand.
규제 업데이트
2026년 9월 20일•1분 읽기
Ajou Pharmaceutical’s Latica Eye Drops 5% Receives Approval as Korea’s 44th Domestic New Drug
Ajou Pharmaceutical, together with G.L. PharmTech, secured MFDS approval for Latica Eye Drops 5% (recopolabone hydrate, code AJU‑S56), marking the company’s first marketed new drug and Korea’s 44th domestically developed new drug for dry eye.
규제 업데이트
2026년 9월 20일•1분 읽기
Low Adoption of Korea's 실손24 Electronic Claim Service Limits Indemnity Insurance Use
Government promotion of the 실손24 electronic claim service has seen limited uptake, with only 13% of indemnity insurance holders enrolled as of July 2026.
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규제 업데이트
2026년 9월 20일•1분 읽기
South Korea to Shorten Health‑Insurance Listing Period for Rare Disease Drugs to 100 Days
The Ministry of Health and Welfare approved a pilot to cut the health‑insurance listing window for rare disease treatments from 240 days to up to 100 days and simplify reimbursement procedures.
규제 업데이트
2026년 9월 20일•1분 읽기
South Korea Proposes Bills to curb Healthcare Workplace Bullying
Lawmakers propose amendments to the Health Care Personnel Support Act, Medical Service Act, and Nursing Act to strengthen protection against workplace bullying in medical institutions.
규제 업데이트
2026년 9월 20일•1분 읽기
South Korea freezes 2027 health insurance contribution rate at 7.19%
The Ministry of Health and Welfare confirmed the 2027 health insurance premium rate will remain at 7.19% for both employee and regional subscribers, keeping the property premium score at 211.5 won.
규제 업데이트
2026년 9월 20일•1분 읽기
KPA and MFDS to Hold Parametric Release Training for Sterile Product Manufacturers on Sep 29
The Korea Pharmaceutical Bio Association and the Ministry of Food and Drug Safety will host a technical training on parametric release for final sterilized product manufacturers on September 29 in Cheongju.
규제 업데이트
2026년 9월 20일•1분 읽기
South Korean Parliament Introduces Bills to Support Health‑Tech Innovation and Reduce Regulatory Barriers
The National Assembly has filed two bills—one amending the Health‑Medical Technology Promotion Act and another proposing a regulatory sandbox—to accelerate validation and commercialization of new health‑care technologies.
규제 업데이트
2026년 9월 20일•1분 읽기
Korea clarifies drug reimbursement classification in health insurance law amendment
The Ministry of Health and Welfare announced that a State Council‑approved amendment to the National Health Insurance Act now clearly defines reimbursable and non‑reimbursable drugs, while preserving protections for severe and rare disease patients.
규제 업데이트
2026년 9월 20일•1분 읽기
Cheongju Pharmacists Association Holds Meeting on Pharmacy Policy Changes and Warehouse-Type Pharmacies
The Cheongju City Pharmacists Association convened a meeting on Sep 7 to discuss recent regional pharmacy issues and challenges of non-face-to-face drug delivery, focusing on warehouse-type pharmacies.
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규제 업데이트
2026년 9월 20일•1분 읽기
Labor Unions Demand Immediate 20% National Treasury Support for Health Insurance
Labor unions urged the government to promptly apply the statutory 20% national treasury support and devise financial measures to strengthen health insurance coverage.