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FDA, EMA, TGA and global regulatory developments

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Regulatory Updates
Sep 14, 2026•1 min read
Gangdong District Pharmacists Association Schedules 2026 H2 Mandatory Training
The association will hold a mandatory 8‑hour pharmacist training on Sep 19 at Gangdong Kyung Hee University Hospital for pharmacists who have not met the annual requirement.
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Regulatory Updates
Sep 14, 2026•1 min read
Huons N Triples Chuncheon Plant Capacity and Secures PSM Approval
Huons N’s Chuncheon facility expands output to 16,500 t/yr and obtains Process Safety Management approval, enabling larger-scale contract manufacturing of functional ingredients.
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Regulatory Updates
Sep 14, 2026•1 min read
Korean Pharmacists Demand Clarification of Scope Between Pharmacists and Herbal Pharmacists
Pharmacist groups have held relay rallies for 350 days, urging the government to define licensing duties and tighten drug‑handling rules.
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Regulatory Updates
Sep 14, 2026•1 min read
Health and Welfare Committee Subcommittee to Review Pharmacist Law Amendments Mid-Month
The Health and Welfare Committee’s bill review subcommittee is expected to meet in mid‑month to consider pending pharmacist‑related legislation, including amendments to the pharmacist law.
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Regulatory Updates
Sep 14, 2026•1 min read
Onnuri Responds to Pharmacist Societies' Inquiry on Mega Onnuri Pharmacy Model
Onnuri clarified that Mega Onnuri pharmacies operate under an independent pharmacist franchise model, detailing the head office’s role and sub‑lease structure after regional societies raised concerns.
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Regulatory Updates
Sep 14, 2026•1 min read
South Korea Establishes Regional Essential Public Healthcare Office, Names Son Young‑rae Director
South Korea's Ministry of Health and Welfare creates a new office to integrate regional, essential and public healthcare, with its first director pledging collaborative action to close medical gaps.
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Regulatory Updates
Sep 14, 2026•1 min read
South Korea Introduces New Designation for Semi‑Innovative Pharma Firms with R&D‑Based Price Benefits
Korea's Ministry of Health and Welfare unveils a designation system granting generic price incentives to semi‑innovative pharma companies that meet R&D investment thresholds, excluding violations older than five years.
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Regulatory Updates
Sep 14, 2026•1 min read
Korean Health Care Alliance protests 14.4% national health insurance support rate
The Health Care Organizations Union criticizes the government's decision to set next year's health insurance national support at 14.4%, calling it an insult to workers and low‑income citizens.
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Regulatory Updates
Sep 14, 2026•1 min read
Guro‑gu Pharmaceutical Association Urges Caution on Expanding Telemedicine Prescription Delivery
The Guro‑gu Pharmacy Association delivered local pharmacists’ concerns to the National Assembly, warning that a full rollout of remote prescription delivery could impact community pharmacy networks and patient safety.
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Regulatory Updates
Sep 13, 2026•1 min read
Health sector takes 16.2% of Korea's tax spending in 2024
A National Assembly Budget Office study finds health receives 16.2% of total tax spending in 2024, the third‑largest share after social welfare and industry.
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Regulatory Updates
Sep 13, 2026•1 min read
Pharmacists and Civil Groups Protest Government Plan to Expand Telemedicine Drug Delivery
The Korean government has begun discussing nationwide drug delivery for telemedicine patients, prompting pharmacists and civil society to organize a protest in Seoul.
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Regulatory Updates
Sep 13, 2026•1 min read
Gwangju Pharmacy Association Calls for Further Review of Mega Onnuri Pharmacy Franchise Model
The Gwangju Pharmaceutical Association, together with Gyeonggi and Gangwon societies, seeks additional review of Onnuri H&C’s response on the Mega Onnuri Pharmacy, citing concerns over fairness, impact and sub‑lease structures.