규제 업데이트

The National Assembly Legislative Research Service held a ceremony on Sept 3 to celebrate reaching 100,000 cumulative inquiries, attended by lawmakers and officials.

Health Canada now contraindicates TZIELD in patients with active EBV or CMV infection, severe lymphopenia, or who are immunocompromised.

Oncogenic Therapeutics secured MFDS approval for a Phase 3 study of its P‑CAB drug Zaqibo to treat Helicobacter pylori infection in 414 patients across 24 Korean sites.

The association will hold a mandatory 8‑hour pharmacist training on Sep 19 at Gangdong Kyung Hee University Hospital for pharmacists who have not met the annual requirement.

Huons N’s Chuncheon facility expands output to 16,500 t/yr and obtains Process Safety Management approval, enabling larger-scale contract manufacturing of functional ingredients.

Lawmaker Seo Young‑seok (Democratic Party) introduced a bill to broaden theft‑and‑leak prevention obligations from medical narcotics to all narcotics, including standard substances and raw‑material drugs.

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

Jeil Pharma Holdings provided legal education on contract practice and fair trade law to team leaders across its subsidiaries, reinforcing compliance management.

MHRA released several Field Safety Notices between 7‑11 September 2026, covering a platelet factor 4‑heparin antibody IVD and an orthopaedic fixation plate among others.

Korea United Pharm announced that its Sejong‑1 plant passed a re‑inspection by Ukraine’s drug regulator, maintaining its GMP certification.

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.

The UK MHRA has decided to withdraw the marketing authorisation for Tavneos (avacopan) for ANCA-associated vasculitis, halting new patient supply from 1 Sept.