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規制動向

FDA、EMA、TGA および世界の規制動向

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規制動向
2026年8月30日•1分で読めます
MFDS orders recall of Il Dong Pharma's Consenvita Premium 800 tablets due to labeling omissions
The Korean MFDS has ordered a retailer‑initiated recall of Il Dong Pharmaceutical’s Consenvita Premium 800 tablets (batch RWC009, RWC010) because of missing labeling information and packaging errors.
UPDATED
規制動向
2026年8月30日•1分で読めます
Pharmacist Consults on Harsh Tax Audit Result and Appeal Process
A pharmacist reports an unexpectedly severe tax audit assessment and receives advice on the taxpayer’s right to appeal and the pre‑notice review stage.
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規制動向
2026年8月30日•1分で読めます
Amgen Initiates Voluntary Recall of ~1M Bottles of Corlanor in US
Amgen voluntarily recalls about 1 million bottles of its heart‑failure drug Corlanor in the US after potential foreign particles were identified.
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規制動向
2026年8月30日•1分で読めます
Health Insurance Co‑Payment Cap Beneficiaries Rise 6.5% Annually, Costs Climb
Supporters of Korea's health‑insurance co‑payment cap grew by an average 6.5% per year, reaching 2.135 million in 2025 with expenditures of 2.792 trillion KRW.
UPDATED
規制動向
2026年8月30日•1分で読めます
2025 Korean Local Governments Miss Disability Employment Quotas
Analysis shows 139 of 226 Korean local governments failed to meet mandatory disability employment rates for 2025.
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規制動向
2026年8月30日•1分で読めます
Korean Lawmaker Proposes Inclusive Content Industry Amendment
Lawmaker Choi Hyuk‑jin introduced a bill to amend the Content Industry Promotion Act, aiming to ensure equal access and participation for disabled, elderly, and multicultural families.
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規制動向
2026年8月30日•1分で読めます
32 New Drugs Added to Korea Health Insurance Reimbursement List in H1 2024
32 drugs were newly listed or had expanded coverage, benefiting about 76,600 patients and costing roughly 741 billion KRW annually.
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規制動向
2026年8月30日•1分で読めます
Korean Pharmaceutical Association Calls for Mandatory Reporting of Human Drugs Used in Veterinary Clinics
The Korean Pharmaceutical Association urges amendment of the Veterinarian Act to require veterinarians and animal hospitals to report usage of human prescription drugs, citing limits of the current pharmacy sales reporting system.
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規制動向
2026年8月30日•1分で読めます
경방신약, 기준서 미준수로 의약품 제조 1개월 정지
경방신약이 제조관리기준서 등 지시서 미준수로 식품의약품안전처로부터 7월 한 달간 두 품목 제조 정지 처분을 받았다.
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規制動向
2026年8月30日•1分で読めます
Korean Parliament Proposes Stricter OTC Drug Sales Controls and Medication Guidance
New bills aim to tighten OTC drug sales to minors and require pharmacies to keep sales records, sparking debate over added burdens on pharmacies.
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規制動向
2026年8月30日•1分で読めます
2027 Minimum Wage Talks Resume; Pharmacies Monitor Labor Cost Implications
The 12th full meeting of the Minimum Wage Committee will resume on the 7th to discuss the 2027 wage, with pharmacies closely watching the outcome for staffing cost planning.
UPDATED
規制動向
2026年8月30日•1分で読めます
KPA Marks 292nd Day of One-Person Protest Over Herbal Pharmacist Pharmacy and OTC Sales
The Korean Pharmaceutical Association continued its 292‑day relay protest, urging the government to resolve the herbal pharmacist’s right to open pharmacies and sell OTC medicines.