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.
1
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.
Regulatory Updates
Sep 3, 2026•1 min read
President Lee Calls for Rapid Approval and Prescription System for Abortion Medication
President Lee Jae‑myung urged ministries to swiftly approve and integrate abortion drugs into a public safety framework, with lawmakers pressing parliament for rapid action.
1
Regulatory Updates
Sep 2, 2026•1 min read
Progen Begins High‑Dose Phase 1 Trial of PG‑102 for Obesity
Progen has received MFDS approval to start a high‑dose Phase 1 study of its obesity/diabetes candidate PG‑102, assessing safety, tolerability and PK/PD at Seoul St. Mary’s Hospital.
Regulatory Updates
Sep 2, 2026•1 min read
MFDS approves zinc citrate and iron chelate as new nutrient‑fortification ingredients
The Korean MFDS has designated zinc citrate and iron chelate as approved nutrient‑fortification agents for foods and health supplements, effective Jan 1 2028.
Regulatory Updates
Sep 2, 2026•1 min read
Samchundang Pharma receives manufacturing suspension over test record violations and recall plan failure
Samchundang Pharmaceutical was ordered to halt production after the MFDS found irregularities in a potency test and a failure to submit a recall plan for its contracted Lefurozin syrup.
1
Regulatory Updates
Sep 1, 2026•1 min read
KPA Issues Alternative Drug List After DiOctahedral Mesylate Pediatric Indication Removed
Following the MFDS removal of the >24‑month pediatric indication for dioctahedral mesylate, the Korean Pharmaceutical Association provided a list of 32 OTC and 15 prescription alternatives for member pharmacies.
Regulatory Updates
Sep 1, 2026•1 min read
Korea Novo Nordisk Pharma’s Alhemo Prefilled Pen Gains MFDS Approval for Hemophilia A & B Prophylaxis
Alhemo® prefilled pen (consiliumab) received MFDS approval for routine prophylaxis in patients 12 years and older with hemophilia A or B, offering a new treatment option in South Korea.
Regulatory Updates
Aug 31, 2026•1 min read
Daewoong Bio Revamps Prescription Drug Packaging Following MFDS Safety Initiative
Daewoong Bio is redesigning packaging for its entire prescription line to improve visual identification and reduce compounding errors, aligning with the MFDS’s July push for safer drug labeling.
Regulatory Updates
Aug 31, 2026•1 min read
Korean Lawmaker Reports Decrease in Medical Narcotics Misuse Cases After Legislative Reform
Legislative changes aimed at improving narcotics prescription management have led to a measurable drop in reported misuse cases among medical professionals in 2026, according to Rep. Jeon Jin-suk.
Regulatory Updates
Aug 31, 2026•1 min read
Regulatory inspections reveal rising PDRN use in Korean cosmetics
Inspections by Korea's MFDS show a sharp increase in companies labeling skin‑boosting cosmetics with PDRN, rising from 7 cases in 2023 to 39 in 2025.
Regulatory Updates
Aug 30, 2026•1 min read
Korean Court Overturns Rejection of Jointstem Stem Cell Therapy for Osteoarthritis
Seoul Administrative Court ruled in favor of R&L Regenerative Medicine, canceling the MFDS’s 2025 rejection of Jointstem, a stem‑cell treatment for osteoarthritis.