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Regulatory Updates

FDA, EMA, TGA and global regulatory developments

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Regulatory Updates
Sep 4, 2026•1 min read
KADA Receives First ‘Excellent (A)’ Rating in 2025 Public Institution Management Evaluation
The Korea Anti-Doping Agency (KADA) earned an ‘Excellent (A)’ rating for the first time since its establishment in the 2025 Ministry of Culture, Sports and Tourism management performance review.
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Regulatory Updates
Sep 4, 2026•1 min read
Pharmacists and Students Hold 301‑Day Relay Protest at Cheong Wa Dae Over Han Yaksa Issues
On the 301st day of the relay protest, the Jeonbuk Pharmacists Association and pharmacy students gathered at Cheong Wa Dae demanding swift government and parliamentary action on Han Yaksa concerns.
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Regulatory Updates
Sep 4, 2026•1 min read
KPA Marks 300 Days of Protest Over Herbal Pharmacist Licensing
The Korean Pharmacists Association held its 300‑day rally, urging the government and parliament to resolve the licensing system for herbal pharmacists and fulfill promises on Korean medicine segregation.
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Regulatory Updates
Sep 4, 2026•1 min read
Korea Pushes Pharmacy Law Amendment to Block External Capital in Pharmacies
A draft amendment to the Pharmacy Act seeks to prevent external capital from managing pharmacies, with calls to speed up enactment and apply it retroactively to existing stores.
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Regulatory Updates
Sep 4, 2026•1 min read
Korea Pharmaceutical Safety Agency Highlights Updated Narcotics Regulations at KMA 2026 Conference
The agency announced expanded verification of medical narcotics to include zolpidem and revised safety standards for narcotic analgesics, promoting the changes at the KMA 2026 conference.
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Regulatory Updates
Sep 4, 2026•1 min read
Germany Passes Health Insurance Premium Stabilization Law, Seen as Benchmark for Korea
Germany's Bundestag approved a law to stabilize statutory health insurance premiums, expanding high‑income contributors' burden while capping spending on providers and medicines, drawing attention from Korea.
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Regulatory Updates
Sep 3, 2026•1 min read
Temporary Reimbursement Granted for Pediatric Smectite After Indication Removal
Korean Pharmaceutical Association secured a three‑day temporary reimbursement for di‑octahedral smectite dispensed to patients under 19, easing pharmacy billing concerns after pediatric indication was withdrawn.
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UPDATED
Regulatory Updates
Sep 3, 2026•1 min read
Korean Pharmacist Group Calls for Further Revisions to OTC Standard Manufacturing Criteria
The Korean Ministry of Food and Drug Safety announced a partial amendment to OTC drug manufacturing standards; a pharmacist association praised the move but urged broader, realistic updates.
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Regulatory Updates
Sep 3, 2026•1 min read
MFDS to Hold Public-Private Forum on Digital Convergence Medicines Regulation
The MFDS will host a public‑private meeting on the 15th in Seoul to discuss regulatory and review processes for digital convergence medicines under the Digital Medical Device Act.
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Regulatory Updates
Sep 3, 2026•1 min read
Korean Government Boosts Drug Prevention Education, Youth Awareness Scores Rise
Drug prevention education in Korea improves risk awareness and confidence to refuse, with youth perception scores climbing from 64.5 to 83.8 between 2024 and 2025.
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Regulatory Updates
Sep 3, 2026•1 min read
South Korea adds 12 hospitals to police investigation over alleged cancer patient fee refunds
The Ministry of Health and Welfare has asked police to investigate 12 additional medical institutions suspected of providing fee refunds ('payback') to cancer patients, raising the total to 18 cases.
UPDATED
Regulatory Updates
Sep 3, 2026•1 min read
German Parliament Passes Health‑Insurance Reform Raising Original Drug Discount to 15.5%
The Bundestag approved a reform that lifts the mandatory discount on original medicines from 7% to 15.5%, despite opposition from pharma groups.