Regulatory Updates

Lawmaker Lee Kwang‑hee introduced five amendment bills to reduce the three‑year mandatory service for qualified health personnel, aligning it closer to the 18‑month term for regular soldiers.

The government plans to consolidate the Korean Rare Essential Medicines Center, the Pharmaceutical Safety Management Agency and the Vaccine Safety Technology Support Center under a new Korean Pharmaceutical Safety Agency.

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.

Korea Pfizer announced that etanercept (Enbrel) will be reimbursed by national health insurance for severe active non‑radiographic axial spondyloarthritis patients starting September 1, expanding treatment access.

Experts highlighted adult obesity as a chronic disease and national health issue, calling for improved treatment access and a state‑level management system at the ICOMES policy session.

Jeonbuk pharmacists gathered outside the presidential office, urging the government and parliament to resolve the issue of traditional‑medicine pharmacists selling OTC drugs.

월말·월초 청구 집중 시 약국들의 시스템 접속 지연이 반복돼 대한약사회가 건강보험심사평가원에 운영 환경 개선을 요구했다.

Qurocell’s CAR‑T product Rimkato (anvalkaptagen autologous cell) has cleared the Cancer Disease Review Committee and the Drug Reimbursement Evaluation Committee, opening the path to health‑insurance coverage and a potential market launch within the year.

The Korean pharmaceutical and biotech sector has secured a limited buffer period as the government delays and adjusts price‑cut criteria for re‑evaluated listed drugs.

Lawmaker Kwon Chil‑seung filed an amendment to the Health and Medical Technology Promotion Act to establish a regulatory sandbox for health‑medical innovations.

Lawmakers and the Korean Rare & Intractable Disease Association held a press conference urging that rare disease patients not be sidelined in policy priorities.

The domestically developed CAR‑T drug Rimkato (Anbalcapatgen Autolyscel) cleared the drug reimbursement evaluation committee, moving closer to inclusion in national health‑insurance coverage.