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Regulatory Updates

FDA, EMA, TGA and global regulatory developments

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Regulatory Updates
Sep 21, 2026•1 min read
South Korea Confirms First Japanese Encephalitis Case of 2024
A woman in her 60s was hospitalized with Japanese encephalitis, marking the first case in South Korea this year; authorities urge vaccination and preventive measures.
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Regulatory Updates
Sep 21, 2026•1 min read
South Korea Introduces Bill to Restrict National Pension Post-Payment for Foreigners
A bill was filed on the 9th to add reciprocity rules to South Korea's national pension system, aiming to curb foreign nationals' misuse of post‑payment contributions.
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Regulatory Updates
Sep 21, 2026•1 min read
Korean Pharmaceutical Association Forms Emergency Committee to Oppose Telemedicine Drug Delivery Expansion
The Korean Pharmaceutical Association has formed an emergency response committee and held a launch ceremony to block the government's plan to expand prescription drug delivery via telemedicine.
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Regulatory Updates
Sep 21, 2026•1 min read
Korean Pharmaceutical Association Calls Nationwide Pharmacist Rally to Block Expansion of Remote Prescription Drug Delivery
The KPA’s emergency committee will hold a national pharmacists rally on the 20th, refusing to join the government‑private task force on remote drug delivery and planning protests at key ministries.
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Regulatory Updates
Sep 21, 2026•1 min read
MFDS recalls 4 hand sanitizers after content non‑compliance in nationwide test
The Korean Food & Drug Administration tested 100 top‑selling hand sanitizers and found four failing the ingredient‑content standards, prompting sales suspension, recall and disposal.
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Regulatory Updates
Sep 21, 2026•1 min read
MFDS Survey Flags Issues at Five Korean Clinical Trial Sites
MFDS’ recent survey identified corrective findings at five hospitals, while Korea University Medical Center had no issues.
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Regulatory Updates
Sep 21, 2026•1 min read
Korea lawmakers discuss rural healthcare policy reforms
Health and Welfare Committee Chair Lee Man-hee and Agriculture Committee Chair Seo Sam-seok co‑hosted a forum to address medical gaps and care burdens in rural areas.
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Regulatory Updates
Sep 21, 2026•1 min read
Understanding Criminal Procedure and Evidence Admissibility in Korean Law
The article explains basic criminal procedure in Korea, noting that evidence obtained unlawfully is inadmissible and may prevent conviction without other proof.
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Regulatory Updates
Sep 21, 2026•1 min read
Il-yang Pharma Ends Russian Deal for CML Drug Suphect, Shifts Focus to China
Il-yang Pharmaceutical terminated its supply and technology export agreement with Russia's R‑Pharm for the domestic new drug Suphect (radotinib) after no local trials, while pursuing Chinese approval.
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Regulatory Updates
Sep 21, 2026•1 min read
Regulatory Shift Reduces Comparative Clinical Trials in Biosimilar Development
Large-scale comparative clinical efficacy studies are being scaled back, with global regulators emphasizing advanced quality analysis and PK data, according to a KoBIA report.
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Regulatory Updates
Sep 21, 2026•1 min read
Korean Pharmaceutical Association Forms Emergency Committee to Block Telemedicine Drug Delivery Expansion
The Korean Pharmaceutical Association launched an emergency response committee to oppose the government's plan to expand prescription drug delivery for telemedicine, announcing coordinated action across regional branches.
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Regulatory Updates
Sep 21, 2026•1 min read
Competition Heats Up for New National Medical School Planned to Open by 2030
Jeonnam Gwangju Suncheon University and Gyeongbuk Gyeongguk University vie for a 100‑seat national medical school, sparking parliamentary debate and mixed local reactions.