規制動向

A relay demonstration by regional pharmacist societies and the Korean Pharmaceutical Association continued for the 341st day, urging the government and National Assembly to address longstanding Han‑Yak‑Sa concerns.

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.

Pineteplaac for Dravet syndrome, Breztri Aerosphere for COPD, Polaiviju for DLBCL and Beova‑jeong for overactive bladder are expected to enter Korea's health‑insurance reimbursement list on Sep 1, pending final approval.

The government plans to discuss expanding medication delivery for all telemedicine users, but the pharmacist association protests, citing premature implementation of the revised medical law.

A draft amendment limiting pharmacy names is set for a plenary vote in Korea, raising questions about which names are affected and the transition timeline for existing pharmacies.

The Korean government’s proposal to broaden prescription drug delivery to all telemedicine patients has sparked strong backlash from the pharmacy community, citing lack of legal basis and objective data.

Lawmaker Choi Eun-seok proposes an amendment to secure stable funding for emergency medical staff wages and facility upgrades, highlighting gaps in current support provisions.

Lawmaker Park Hee-seung calls for establishing a national medical school and central hospital to resolve structural issues in Korea's regional healthcare.

The Korean government plans to broaden pharmacy information provided to private telemedicine services from simple stock status to detailed purchase and dispensing quantities, prompting industry worries over data exposure.

The Dongjak‑gu Pharmacy Association warned that expanding prescription drug delivery for telemedicine could worsen health‑insurance finances and increase drug misuse, calling for an immediate stop.

보건복지부가 2026년 혁신형 제약기업 신규·재인증을 위한 세부 평가기준을 전면 확정 공고했습니다.