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FDA, EMA, TGA and global regulatory developments

#South Korea ×

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Regulatory Updates
Sep 7, 2026•1 min read
South Korea passes pharmacist law amendment restricting pharmacy names that may promote drug overconsumption
The National Assembly approved a pharmacist law amendment limiting pharmacy names that could encourage excessive drug use; the Health Ministry issued a supporting statement.
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Regulatory Updates
Sep 7, 2026•1 min read
South Korean Lawmaker Proposes Amendment to Align National Health Insurance Act Terminology with Tax Collection Law
Lawmaker Baek Jong-heon introduced a bill to replace the term “delinquent disposition” with “forced collection” in the National Health Insurance Act, correcting a six‑year inconsistency with the National Tax Collection Act.
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Regulatory Updates
Sep 6, 2026•1 min read
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.
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Regulatory Updates
Sep 6, 2026•1 min read
South Korean Health NGOs Criticize Government's Telemedicine Drug Delivery Expansion
Civil society health groups in South Korea denounced the Lee Jae‑myung administration’s plan to fully expand telemedicine drug delivery, urging investment in public medical infrastructure instead.
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Regulatory Updates
Sep 6, 2026•1 min read
South Korea debates expanding drug delivery for telemedicine patients amid pharmacist opposition
The government plans to discuss expanding medication delivery for all telemedicine users, but the pharmacist association protests, citing premature implementation of the revised medical law.
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Regulatory Updates
Sep 5, 2026•1 min read
South Korea to Expand Pharmacy Data Shared with Telemedicine Platforms, Raising Privacy Concerns
The Korean government plans to broaden pharmacy information provided to private telemedicine services from simple stock status to detailed purchase and dispensing quantities, prompting industry worries over data exposure.
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Regulatory Updates
Sep 5, 2026•1 min read
South Korea's Parliament Accelerates Pharmacy Legislation, Eyes Pharmacy Name Restriction Act
The National Assembly is set to convene this week, focusing on the pending Pharmacy Name Restriction Act that would bar misleading pharmacy names, following recent network pharmacy and telemedicine restrictions.
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Regulatory Updates
Sep 5, 2026•1 min read
Korean Government Considers Expanding Telemedicine Drug Delivery, Legislative Review Ongoing
Debate continues on whether to discuss further regulatory improvements for telemedicine‑based medication delivery before the system is launched, highlighting the need for legislative action.
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Regulatory Updates
Sep 5, 2026•1 min read
68 Korean Medicines Face Insurance Price Cuts Starting Sept 1, Pharmacies Warned on Returns
From Sept 1, insurance reimbursement prices for 68 drugs in South Korea will drop, with reductions ranging from under 1% to over 20%; pharmacies must manage inventory differences and physical returns.
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Regulatory Updates
Sep 4, 2026•1 min read
New Minimum Wage Bills Target Small Businesses, May Affect Pharmacies
Bills to adjust minimum wage based on business size and to support at‑risk small retailers have been introduced, raising questions about impacts on Korean pharmacies.
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Regulatory Updates
Sep 3, 2026•1 min read
Green Cross fined for delayed post‑marketing study of Hantabax hemorrhagic fever vaccine
South Korea’s MFDS imposed a fine on Green Cross after the company missed the deadline for a post‑marketing efficacy study required under the vaccine’s risk management plan.
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Regulatory Updates
Sep 2, 2026•1 min read
South Korean President’s Call Revives Domestic Mifepristone Approval Talks
President Lee Jae‑myung’s remarks on safe, medically supervised use of mifepristone prompted the government to revisit its approval, sending Hyundai Pharmaceutical’s shares to a limit, though experts caution approval is not guaranteed.