Regulatory Updates
Sep 11, 2026•1 min read
MFDS Revises Pharmaceutical Pre‑GMP Evaluation Manual, Adds New‑Drug and Singapore GMP Provisions
South Korea's MFDS updates its pre‑GMP evaluation handbook after 5 years, introducing dedicated teams for new drugs and incorporating the Korea‑Singapore GMP mutual‑recognition agreement.
Regulatory Updates
Sep 10, 2026•1 min read
South Korea proposes amendment to require employers to stock emergency medicines at workplaces
A pharmacy‑law amendment introduced by lawmaker Jeon Yong‑gi would obligate businesses to keep and provide safety standby medicines for employee emergencies.
Regulatory Updates
Sep 10, 2026•1 min read
Korean Lawmaker to Host Forum on Innovative Drug Value Assessment Sep 4
Lawmaker Seo Mi-hwa will hold a policy forum on Sep 4 to discuss new directions for valuing innovative medicines amid emerging therapies.
Regulatory Updates
Sep 10, 2026•1 min read
Korea Pharmaceutical Safety Agency Announces 2026 Second‑Half Narcotics Handling Education
The Korea Pharmaceutical Safety Management Agency will hold a mandatory training on September 29 for dental, veterinary, pharmacy and wholesale professionals on new narcotics safety reporting and supervision rules.
Regulatory Updates
Sep 10, 2026•1 min read
Korean Health Insurance Drug List Shrinks, OTC Items Decline Faster Than Prescription
The number of drugs covered by Korea’s health insurance has fallen steadily, with over‑the‑counter medicines dropping 25.2% over five years—more sharply than prescription drugs.
Regulatory Updates
Sep 9, 2026•1 min read
Korean Pharmacists' 345-Day Protest Calls for Han-Yak-Sa Reform
The Korean Pharmacists Association continued its 345-day relay rally in front of the Blue House, urging reforms to the han-yak-sa licensing system and resolution of longstanding issues.
Regulatory Updates
Sep 9, 2026•1 min read
Korea MFDS Expands GIFT Review to Include Patient Experience Data
The Korean MFDS revised its GIFT fast‑track guidelines, permitting patient‑reported symptoms, quality‑of‑life data, preferences, interviews, videos and written opinions as reference material for priority review of rare disease drugs.
Regulatory Updates
Sep 9, 2026•1 min read
JW중외제약, 보팡글루타이드 2형 당뇨병 3상 임상 IND 신청
JW중외제약이 비만용 GLP‑1 ‘보팡글루타이드’의 2형 당뇨병 적응증을 위한 3상 임상 IND를 식품의약품안전처에 제출, 174명 대상 2024년 1월 시작 예정.
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Regulatory Updates
Sep 9, 2026•1 min read
Parliamentarians Host Policy Forum on Bio‑Data Platform Activation
A policy forum on activating bio‑data utilization platforms was held on Aug 28 at the National Assembly, organized by the Korean Medical Data Association and the Korea Industry Federation Forum, with participation from lawmakers and industry leaders.
Regulatory Updates
Sep 9, 2026•1 min read
JoA Pharmaceutical Reintroduces Gareo-Aq Digestive Medicine After 3-Year Clinical Reassessment
JoA Pharmaceutical has re‑launched its OTC digestive aid Gareo‑Aq, featuring DHBE, after completing a three‑year clinical re‑evaluation across six Korean medical centers.
Regulatory Updates
Sep 9, 2026•1 min read
South Korea adds 15 facilities to police probe over illegal fee refunds
South Korea's Health Ministry has referred 15 additional hospitals and clinics to police over suspected illegal medical fee refunds, bringing the total under investigation to 33.
Regulatory Updates
Sep 8, 2026•1 min read
Essential Medicine Supply Disruption Highlighted in Korea’s 2026 National Audit
The Korean Legislative Research Service flagged essential drug shortages as a key health‑welfare issue in its 2026 National Audit analysis, noting gaps between existing plans and a lack of a health‑security control tower.