Regulatory Updates
Sep 7, 2026•1 min read
Human Tissue Distributor A Receives One-Month Suspension for SOP Breach
Company A failed to follow its own tissue handling SOPs during frozen tissue redistribution and was suspended by Korea’s MFDS from Aug 31 to Sep 30.
Regulatory Updates
Sep 7, 2026•1 min read
MFDS Expands Controlled Substance Monitoring to Include Propofol
South Korea's MFDS will extend its medical narcotics prescription monitoring system to cover the anesthetic propofol, with checks advisory and alerts for high‑frequency use.
Regulatory Updates
Sep 7, 2026•1 min read
South Korea Strengthens On‑Site Monitoring of Medical Narcotics with New Training Program
MFDS, Korea Pharmaceutical Safety Management Agency and Seoul city will hold a medical narcotics safety management training for Seoul’s monitoring officials on March 28.
Regulatory Updates
Sep 7, 2026•1 min read
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.
Regulatory Updates
Sep 6, 2026•1 min read
Korean Pharmacies Gain Regulatory Boost for Custom Health Foods
Regulatory updates exempt pharmacies from business registration and provide a checklist, allowing pharmacy managers to act as product managers and outsource splitting without dedicated facilities.
Regulatory Updates
Sep 5, 2026•1 min read
MFDS to Conduct Targeted Inspections of Customized Health Functional Food Sellers Aug 24-28
The Korean Ministry of Food and Drug Safety will inspect customized health functional food vendors from Aug 24-28, conducting guidance, sampling and testing to ensure product safety and quality.
Regulatory Updates
Sep 5, 2026•1 min read
MFDS selects 10 functional ingredients, including bilberry extract, for 2027 re‑evaluation
The Korean MFDS announced ten health‑functional food ingredients, such as bilberry extract, will undergo a regular re‑assessment in 2027.
Regulatory Updates
Sep 5, 2026•1 min read
MFDS Updates Labels for Inhaled Triple Therapy and Caspofungin Amid Post‑Marketing Findings
Korea's MFDS adds new safety precautions to a beclomethasone‑formoterol‑glycopyrrolate inhaler and revises caspofungin labeling regarding CRRT‑related drug adsorption.
Regulatory Updates
Sep 4, 2026•1 min read
MediBioLab launches GumGoods health supplement using MFDS‑approved PMEC ingredient
MediBioLab released GumGoods, a gum‑health functional food leveraging the MFDS‑approved PMEC propolis extract after eight years of research.
Regulatory Updates
Sep 4, 2026•1 min read
Daewoong Bio receives 1‑month manufacturing suspension over claim handling lapse
Daewoong Bio was ordered by South Korea’s MFDS to halt production of its 300 mg Icosapent Ethyl soft capsules for one month after failing to process a consumer claim per its own standards.
Regulatory Updates
Sep 3, 2026•1 min read
Green Cross fined for delayed post‑marketing study of Hantabax hemorrhagic fever vaccine
South Korea’s MFDS imposed a fine on Green Cross after the company missed the deadline for a post‑marketing efficacy study required under the vaccine’s risk management plan.
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.