규제 업데이트

The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.

The FDA records show that three discontinued oral delayed‑release tablet products of Divalproex Sodium (125 mg, 250 mg, 500 mg) received approved labeling supplemental submissions.

The National Assembly’s Health and Welfare Committee presented 376 items—371 bills and 5 petitions—covering health, food‑medicine, and disease control, with a key Pharmacy Act amendment addressing warehouse‑type pharmacies.

The Korean Pharmacists Association urges the government to scrap the 7‑day limit on first‑time telemedicine prescriptions and the planned expansion of drug delivery, citing patient safety.

Cook Medical reports that certain device lots may have a misaligned female luer lock adapter due to manufacturing errors.

Cook Medical reports that certain cystoscopic injection needle lots may have a misaligned female luer lock adapter.

Health Canada alerts that the 3930M transvenous DF4 cardiac lead may suffer driveshaft separation due to insufficient adhesive bonding, potentially leading to lead fracture.

Health Canada warns that IMAAVY solution lots JNYJ1202 and JNYJ1206 may contain glass particles; recall limited to healthcare establishments.

Health Canada identified inadequate adhesive coverage in the model 3930M DF4 transvenous lead, which can cause helix separation and potential lead fracture.

GC Green Cross secured MFDS IND approval for its mRNA COVID‑19 vaccine candidate GC4006A and will begin a Phase 2 study in Korea targeting adults 19‑85, aiming for domestic self‑sufficiency by 2028.

B. Braun Melsungen AG has informed the MHRA of patient information leaflet errors in certain Meropenem 1000 mg powder and solvent batches.

The Korean Pharmacists' Association staged its 357th consecutive relay protest in front of the Blue House, urging the government and National Assembly to clarify licensing scopes and resolve role conflicts between pharmacists and han‑yak (traditional medicine) pharmacists.