Regulatory Updates
Aug 30, 2026•1 min read
Policy Report Calls for Reassessment of Convenience Store OTC Medicine Expansion in Korea
A Korean pharmacists' group urges scaling back the convenience‑store standby drug system after the key product 지사제 is barred for under‑19 use.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS Expands Rehab Linkage for Drug Addicts, Adds 1342 Hotline in 54 Prisons
South Korea's MFDS announced expanded rehabilitation support for drug addicts, linking correctional facilities with community centers and extending the 24‑hour 1342 counseling hotline to 54 prisons.
Regulatory Updates
Aug 30, 2026•1 min read
KPA Announces Health Insurance Reimbursement Halt for DiOctahexdylsMechtaite in Children from July 2026
The Korean Pharmaceutical Association warned pharmacists that, following MFDS approval changes, the pediatric use of DiOctahexdylsMechtaite formulations is prohibited and health‑insurance coverage will cease for prescriptions from July 6 2026.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS Announces Draft Rules for Cosmetics Safety Assessment, Open for Comment
South Korea's MFDS released a draft amendment to the Cosmetic Act enforcement decree and rules on July 8, seeking comments until Aug 18 to detail the new safety assessment system.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS urges careful use of GLP-1 obesity drugs amid misuse concerns
Korea's Ministry of Food and Drug Safety warns that misuse of GLP‑1 obesity treatments is rising and stresses that they must be prescribed and used according to approved indications.
Regulatory Updates
Aug 30, 2026•1 min read
Korea Introduces Real-Time Hazardous Drug Distribution Alert Service
A new notification service lets medical institutions receive real‑time SMS or KakaoTalk alerts on recalled or near‑expiry hazardous drugs distributed to pharmacies, enhancing safety at the compounding stage.
Regulatory Updates
Aug 30, 2026•1 min read
KRPIA Welcomes Korea’s First International Joint Drug Review via EMA’s OPEN Program
The Korea Research-based Pharmaceutical Industry Association (KRPIA) praised the MFDS for completing its first joint drug assessment with overseas regulators through EMA’s OPEN program, conducted simultaneously in Europe and Korea.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS reviews removal of pediatric indication for dioctahedralsmektate antidiarrheal
South Korea’s MFDS is considering deleting the pediatric indication for the dioctahedralsmektate antidiarrheal after safety data were deemed insufficient, following proactive applications by manufacturers.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS Revises Enforcement Regulations to Strengthen R&D Oversight
MFDS amended the Regulatory Science Innovation Act rules, clarifying its head's authority over R&D project selection and updating agency titles, effective immediately.
Regulatory Updates
Aug 30, 2026•1 min read
Korea to ban dioctahedral smectite antidiarrheal from July 13
South Korea's MFDS will prohibit pediatric prescriptions of dioctahedral smectite after finding insufficient safety data on lead content, sparking recall concerns.
Regulatory Updates
Aug 30, 2026•1 min read
South Korea bans pediatric use of Daewoong's Starvic and Daewon's Potagel suspensions
Daewoong’s Starvic and Daewon’s Potagel pediatric diarrhea suspensions are prohibited nationwide in Korea effective July 6, after MFDS found insufficient safety data for children.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS orders recall of Il Dong Pharma's Consenvita Premium 800 tablets due to labeling omissions
The Korean MFDS has ordered a retailer‑initiated recall of Il Dong Pharmaceutical’s Consenvita Premium 800 tablets (batch RWC009, RWC010) because of missing labeling information and packaging errors.