Regulatory Updates
Sep 16, 2026•1 min read
MFDS Identifies GCP Gaps in Dayvigofilm Coating Tablet (Rembolexant) Approval Process
The Korean MFDS flagged protocol adherence, monitoring and record‑keeping issues in the clinical trial for Dayvigofilm coating tablet, though no serious violations were found.
Regulatory Updates
Sep 14, 2026•1 min read
South Korea's MFDS Joins ICMRA Executive Committee, First Time Representation
The MFDS has been elected to the ICMRA Executive Committee for 2026‑2029, marking its first seat on the global drug‑regulation decision body.
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Regulatory Updates
Sep 14, 2026•1 min read
Yuhan Yanghang launches Yuhan Chondroitin 1200 joint health supplement with MFDS‑approved chondroitin sulfate
Yuhan Yanghang introduced Yuhan Chondroitin 1200, a joint and cartilage health supplement containing MFDS‑approved chondroitin sulfate (1200 mg per dose), validated in a 90‑day clinical trial.
Regulatory Updates
Sep 14, 2026•1 min read
Severe Drug Reactions Eligible for Compensation per MFDS Review Committee
MFDS confirms compensation for patients with Stevens‑Johnson syndrome, anaphylactic shock and Dress syndrome after specific drug use.
Regulatory Updates
Sep 14, 2026•1 min read
Kyung Hee University Holds RWD‑Pharmacometrics Training for MFDS Officials
Kyung Hee University’s Department of Regulatory Science, together with Catholic University and the MFDS, completed a RWD‑PMX integration training, certifying 28 participants.
Regulatory Updates
Sep 14, 2026•1 min read
Kyungdong Pharma, Aul Bio Submit IND for Monthly Long-Acting Semaglutide Injection (AUL009)
Kyungdong Pharmaceutical and Aul Bio have filed an IND with South Korea’s MFDS for phase‑1 testing of AUL009, a monthly long‑acting semaglutide injection using the ExTenna™ platform.
Regulatory Updates
Sep 13, 2026•1 min read
MFDS launches new review system to cut new drug approval time to 240 days
South Korea's MFDS will activate a parallel-review process within a month, assigning multiple reviewers per area to reduce new drug approval timelines to 240 days.
Regulatory Updates
Sep 13, 2026•1 min read
Pharma Research Faces 2-Month Advertising Suspension for Rejuran Derma Hiller Por Tightening Ampoule
Pharma Research's cosmetic product 'Rejuran Derma Hiller Por Tightening Ampoule' will have its online advertising halted for two months due to potentially misleading clinical claims, per MFDS.
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
MFDS updates safety labeling for triptolide and azathioprine drugs
The Korean MFDS will amend approval labeling for triptolide and azathioprine products, adding severe skin reaction warnings for triptolide and PRES and tremor warnings for azathioprine.
Regulatory Updates
Sep 9, 2026•1 min read
MFDS revises GIFT review guidelines to include patient experience for rare disease drugs
South Korea's MFDS updated its GIFT fast‑track review criteria on March 28, adding patient real‑world experience to priority assessment for innovative rare‑disease therapies.
Regulatory Updates
Sep 9, 2026•1 min read
MFDS adds domperidone contraindication for chromaffin‑cell tumor patients across 38 products
South Korea’s MFDS will revise labeling of 38 domperidone products to contraindicate use in patients with chromaffin‑cell tumors due to risk of severe hypertension.