Regulatorische Updates

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.

The MFDS has been elected to the ICMRA Executive Committee for 2026‑2029, marking its first seat on the global drug‑regulation decision body.

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.

MFDS confirms compensation for patients with Stevens‑Johnson syndrome, anaphylactic shock and Dress syndrome after specific drug use.

Kyung Hee University’s Department of Regulatory Science, together with Catholic University and the MFDS, completed a RWD‑PMX integration training, certifying 28 participants.

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.

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.

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.

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.

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.

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.

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.