Regulatorische Updates

Albozen Korea announced it will handle domestic distribution of Eurobaxom®, a prescription drug for recurrent/chronic urinary tract infections, with the marketing authorisation transfer slated for Q4 2026.

Yuhan Yanghang says it follows global bio‑ethics standards, using ICH guidelines and the Helsinki Declaration, and continuously monitors adverse events to protect trial participants.

Rimkatoju, Korea’s first home‑grown CAR‑T drug, passed the first review for national health‑insurance reimbursement, while HER2‑positive breast cancer drug Purgeta’s expansion was postponed.

NECA reported that two autologous platelet‑rich plasma treatments – nasal injection and rotator‑cuff injection – were deemed safe and effective by the 4th New Medical Technology Evaluation Committee.

Patient groups push for rapid reimbursement approval of Rimkatoju, a Korean CAR‑T treatment for relapsed/refractory large B‑cell lymphoma, as HIRA’s cancer committee revisits the issue.

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.

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.

Vera Therapeutics' atacicept, branded Trutakna, received FDA accelerated approval as the sixth therapy for IgA nephropathy, the first U.S. drug to block both BAFF and APRIL.

Lotte Biologics announced on the 22nd that its Phase‑1 facility at Incheon’s Songdo Bio Campus has received use approval, marking completion of major construction within about two years.

Hyundai Bio reports that its broad‑spectrum antiviral candidate Xafty (XAFTY) achieved a negative genotoxicity result in a GLP micronucleus assay, adding safety data ahead of the AIR‑V trial.

South Korea's Ministry of Health and Welfare announced a public hearing on the proposed Digital Healthcare and Health Information Utilization Support Act, inviting experts and the public to discuss key issues.

From July 21, pharmacies are required to submit detailed reports of human-use prescription drugs sold to animal hospitals, with penalties up to 1 million KRW for non‑compliance.