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法规动态

FDA、EMA、TGA 及全球法规动态

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法规动态
2026年9月7日•1 分钟阅读
광주지방법원, 처방전 외 약 조제 약사에 300만원 벌금 선고
광주지방법원은 처방전에 없는 약을 조제한 약사에게 업무상 과실치상으로 300만원 벌금을 부과했다.
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法规动态
2026年9月7日•1 分钟阅读
MFDS reveals illegal distribution of unapproved foreign medicines in Korean import markets
A joint inspection of 10 import shopping centers uncovered unapproved Japanese and US medicines, including pain relievers, cold drugs, gastrointestinal meds, and psychoactive substances, sold without approval.
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法规动态
2026年9月7日•1 分钟阅读
Korean National Audit Flags Weak Telemedicine Narcotics Prescription Oversight
The Legislative Research Service highlighted inadequate monitoring of narcotic prescriptions via telemedicine as a 2026 National Audit issue, urging real‑time oversight.
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法规动态
2026年9月7日•1 分钟阅读
Korean Pharmaceutical Association Forms Emergency Committee to Address Expanded Telemedicine Drug Delivery
The Korean Pharmaceutical Association, led by President Kwon Young‑hee, has created an emergency response committee to address the government’s plan to fully expand medication delivery for telemedicine patients.
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法规动态
2026年9月7日•1 分钟阅读
Korean Pharmacists Association Welcomes Pharmacy Naming Law Amendment
The Korean Pharmacists Association praised the National Assembly’s passage of a Pharmacy Act amendment that restricts pharmacy names that could treat medicines as commodities or encourage over‑consumption.
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法规动态
2026年9月7日•1 分钟阅读
Amgen Korea’s Blincyto Gains Health‑Insurance Coverage for Ph‑Negative B‑Cell ALL in Sep 2024
From September, Blincyto (blinatumomab) will be reimbursed for Ph‑negative CD19‑positive precursor B‑cell ALL patients aged ≥1 year who achieve MRD‑negative remission.
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法规动态
2026年9月7日•1 分钟阅读
US Regulators Say AI-Generated Influencers Promoting Supplements Must Meet Same Truth Standards
A New York Times probe found hundreds of AI‑created virtual health personas promoting dietary supplements on social media, prompting US ad regulators to apply existing truth‑in‑advertising rules to AI spokespeople.
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法规动态
2026年9月7日•1 分钟阅读
South Korea Advances Pharmacy Name Restriction Law to curb consumer misuse
A new pharmacy name restriction bill cleared parliamentary review, aiming to prevent medicines being treated like regular consumer goods and curb excessive purchases.
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法规动态
2026年9月7日•1 分钟阅读
Korea health authorities guide duplicate‑prescription claims for disaster‑area patients
The Ministry of Health and Welfare and HIRA issued instructions for residents of Geoje and Tongyeong special disaster zones to cite a ‘C/’ reason when claiming medical benefits for re‑prescribed medicines lost in heavy rain.
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法规动态
2026年9月7日•1 分钟阅读
Six RSA‑covered Oncology Drugs See Contract Changes and Renewals in Korea
Next month, six RSA‑linked medicines—including Tisentric, Opdivo and Blincyto—will have contract terms revised, while six others such as Linparza and Opdivo enter re‑contracting as their RSA periods expire.
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法规动态
2026年9月7日•1 分钟阅读
Korean Pharma & Bio Leaders Call for Next‑Gen Modalities, AI Integration and Regulatory Reform
At CPHI Korea 2026, experts urged Korean pharma and biotech firms to secure next‑generation modalities, fuse physical AI, and expedite preclinical and data legislation updates.
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法规动态
2026年9月7日•1 分钟阅读
Pharmacy Students Urge Caution on Expanding Drug Delivery Services
Pharmacy students stress that expanding medication delivery must consider pharmacists' role and risk of misuse, warning against unchecked growth.