法规动态
FDA、EMA、TGA 及全球法规动态
法规动态
2026年8月31日•1 分钟阅读
Korea Considers Expanding CGM Insurance Coverage to Type 2 Diabetes Patients
A debate in Seoul proposes broadening health‑insurance benefits for continuous glucose monitors to include type 2 diabetes and shifting reimbursement to a device‑support model, which could benefit pharmacies.
法规动态
2026年8月31日•1 分钟阅读
Korea's First CAR‑T Therapy Rimkato Secures Health‑Insurance Reimbursement Approval
Rimkato (Anvalcapatgen Autologous Cell), Korea's first CAR‑T drug, cleared the health‑insurance reimbursement hurdle, signaling a shift toward domestic cell‑gene therapies.
法规动态
2026年8月31日•1 分钟阅读
South Korea Introduces Bill to Ban Warehouse‑Type Pharmacies
A draft amendment to the Pharmacy Act aims to prohibit 'warehouse‑type' pharmacies, citing concerns over external capital influence and loss of pharmacy independence.
法规动态
2026年8月31日•1 分钟阅读
KPA Relay Protest Marks 295th Day, Calls for Han Yaksa Licensing Reform
The Korean Pharmaceutical Association held its 295th day relay protest, urging reforms to the Han Yaksa licensing system despite heavy rain.
法规动态
2026年8月31日•1 分钟阅读
Daewoong Bio Revamps Prescription Drug Packaging Following MFDS Safety Initiative
Daewoong Bio is redesigning packaging for its entire prescription line to improve visual identification and reduce compounding errors, aligning with the MFDS’s July push for safer drug labeling.
法规动态
2026年8月31日•1 分钟阅读
Myeongin Pharma Advances Parkinson’s Drug P2B001 Toward Korean Approval
Myeongin Pharma seeks Korean approval for P2B001, the world’s first extended‑release Parkinson’s combination drug, as it shifts toward global R&D.
法规动态
2026年8月31日•1 分钟阅读
창고형 약국 방지법 조만간 발의 예정
외부 자본이 개입한 '창고형 약국'을 차단하기 위한 법안이 곧 발의돼 약국 독립성과 공공성 확보가 논의됩니다.
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法规动态
2026年8月31日•1 分钟阅读
Keytruda gains two Korean approvals, adds bladder, ovarian uses
MSD Korea received MFDS approval for two additional Keytruda combination therapy indications, bringing its Korean portfolio to 5 bladder and 2 ovarian cancer indications, covering 18 cancers and 37 indications overall.
法规动态
2026年8月31日•1 分钟阅读
South Korea to Establish Health Personnel Task Adjustment Committee for Pharmacist Scope
The Ministry of Health and Welfare is forming a new Health Personnel Task Adjustment Committee to discuss the work scope of pharmacists and herbal pharmacists, with member nominations due by the 24th.
法规动态
2026年8月31日•1 分钟阅读
South Korea Pushes Community Approach to Drug Addiction
South Korea faces a surge in drug addiction among young adults and urges a shift from punitive measures to disease‑focused, community‑level prevention involving local pharmacies.
法规动态
2026年8月31日•1 分钟阅读
Cresoti reports data breach of e-prescription scanner service
Cresoti confirmed unauthorized access to its EasyScanner and PharmDoc services and reported the incident to Korean privacy and cybersecurity authorities.
法规动态
2026年8月31日•1 分钟阅读
Proposal to Expand Health Insurance Coverage of CGM to Insulin‑Treated Type 2 Diabetes Patients
A policy forum discussed expanding CGM insurance coverage to insulin‑treated type 2 diabetes patients and shifting reimbursement to a direct benefit system.