Regulatorische Updates

In August 2026, the FDA granted Novel Drug approval to at least seven new molecules, including treatments for rare diseases, refractory cancers, blood disorders, HIV, gene therapy and an mRNA flu vaccine.

The Ministry of Health and Welfare approved a pilot to cut the health‑insurance listing window for rare disease treatments from 240 days to up to 100 days and simplify reimbursement procedures.

The Ministry of Health and Welfare announced that a State Council‑approved amendment to the National Health Insurance Act now clearly defines reimbursable and non‑reimbursable drugs, while preserving protections for severe and rare disease patients.

Despite focus on rare disease and oncology, Korea's drug price reform still limits innovative treatments for common chronic conditions, says Seoul National University economist.

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

South Korea’s Ministry of Health and Welfare announced faster reimbursement for Dravet syndrome treatment Fintepla‑Ac and broader coverage for blood‑cancer and pediatric‑leukemia drugs.

The Korean MFDS revised its GIFT fast‑track guidelines, permitting patient‑reported symptoms, quality‑of‑life data, preferences, interviews, videos and written opinions as reference material for priority review of rare disease drugs.

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.

GC Green Cross announced that its Hunter syndrome therapy Hunterraze IV received product approvals from India's CDSCO and Taiwan's TFDA, while the ICV formulation also secured TFDA clearance, expanding its presence in the Asian rare‑disease market.

The committee deemed patients with platelet counts below 50,000/μl an unmet clinical need and granted conditional approval of Handok's Bonjo capsule, pending confirmatory trial data.

The FDA granted approvals for five products in June—including a cell therapy, rare‑disease drug, antibiotic, imaging contrast agent and a biosimilar—signaling trends in advanced biopharma.

Qurocell announced its CAR‑T drug Rimcato has passed the HIRA Severe Disease Review Committee, clearing the first hurdle for national health‑insurance reimbursement.