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FDA, EMA, TGA and global regulatory developments

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Regulatory Updates
Sep 28, 2026•1 min read
NHIS employee suspended for 62 unauthorized personal data accesses
A grade‑5 NHIS staff accessed family and others’ personal data 62 times between Dec 2020 and Nov 2023; a three‑month suspension was imposed in May 2024.
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Regulatory Updates
Sep 28, 2026•1 min read
Korean Pharmaceutical Association to Hold Nationwide Rally Against Telemedicine and Prescription Delivery Expansion
The Korean Pharmaceutical Association will host a large rally on June 20 in Gwanghwamun, uniting pharmacists and pharmacy students to oppose the government's telemedicine and prescription‑delivery expansion, while also raising concerns about platform‑driven medical commercialization and health‑insurance financing.
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Regulatory Updates
Sep 24, 2026•1 min read
Korean Pharmaceutical Association Urges Insurance Coverage for Abortion Induction Drugs
The Korean Pharmaceutical Association calls for dropping in‑hospital compounding of abortion induction drugs and pushing for health‑insurance reimbursement, warning against utilization barriers.
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Regulatory Updates
Sep 22, 2026•1 min read
Lee Yoon-hak, New Head of Drug Price Negotiations, Prioritizes Essential Medicine Access and Innovation
Lee Yoon-hak, appointed head of drug price negotiations at Korea’s Health Insurance Review & Assessment Service, vows to boost essential medicine access, foster new‑drug development and ensure rational post‑pricing management.
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Regulatory Updates
Sep 22, 2026•1 min read
Lawmaker Calls for Removal of Health‑Insurance Limits on Infertility Treatment in Korea
A Korean lawmaker urged the government to lift caps on IVF and IUI coverage under national health insurance, citing patient cost barriers and the need for case‑by‑case care.
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Regulatory Updates
Sep 21, 2026•1 min read
KPA Committee Plans Response to Expanded Telemedicine Drug Delivery
The KPA’s Emergency Committee held its first operating and execution meetings to plan actions against the government’s push to broaden prescription drug delivery for telemedicine.
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Regulatory Updates
Sep 21, 2026•1 min read
Patient groups urge reform of diabetes device reimbursement as CGM and insulin pump coverage expands
With coverage extending to severe type‑2 diabetes, groups call for a shift from upfront payment to direct co‑payment at pharmacies for CGM and insulin pump devices.
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Regulatory Updates
Sep 21, 2026•1 min read
Health Insurance Chair Outlines AI, Telemedicine & Sustainability Plans
Chair Kang Cheong-hee announces AI-driven reforms, electronic prescription system and telemedicine preparations to ensure Korea's health insurance financial sustainability.
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Regulatory Updates
Sep 21, 2026•1 min read
South Korea Expands Insurance Support for Insulin Pumps and CGMs to Severe Type 2 Diabetes
The Ministry of Health and Welfare will extend coverage of insulin pumps and continuous glucose monitors to severe type 2 diabetes patients with pancreatic dysfunction starting December.
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Regulatory Updates
Sep 20, 2026•1 min read
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.
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Regulatory Updates
Sep 20, 2026•1 min read
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.
UPDATED
Regulatory Updates
Sep 20, 2026•1 min read
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.