法规动态
FDA、EMA、TGA 及全球法规动态
法规动态
2026年9月21日•1 分钟阅读
Pharmacist Jin Gyo‑seong Calls for Unity in KPA Amid Telemedicine Delivery Debate
Veteran pharmacist Jin Gyo‑seong urges Korean pharmacists to unite under the KPA and focus on government response to telemedicine prescription delivery and safety‑stock drug expansion.
法规动态
2026年9月21日•1 分钟阅读
South Korea Expands Insurance Support for Insulin Pumps and CGMs to Severe Type 2 Diabetes
The Ministry of Health and Welfare will extend coverage of insulin pumps and continuous glucose monitors to severe type 2 diabetes patients with pancreatic dysfunction starting December.
法规动态
2026年9月21日•1 分钟阅读
FDA Approves Multiple Novel Therapies in August 2026 Targeting Rare Diseases and Unmet Needs
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.
法规动态
2026年9月21日•1 分钟阅读
UK R&D rebate hike prompts AstraZeneca, Merck to pull investment plans
A year after the UK raised NHS rebate rates on new branded medicines to 31.3%, AstraZeneca and Merck withdrew planned R&D investments, citing a challenging innovation environment.
法规动态
2026年9月20日•1 分钟阅读
Korean Health Committee to Review 15 Pharmacy Law Amendments Including External Capital Ban
The National Assembly Health and Welfare Committee will consider 15 pharmacy law amendment bills, such as the external‑capital prohibition and drug sales‑record regulations, at its first full meeting on the 11th.
法规动态
2026年9月20日•1 分钟阅读
MFDS to Classify GLP-1 Obesity Drugs as Potentially Abusable by September
South Korea's MFDS plans to finish designating GLP‑1 obesity treatments such as Wegovy and Mounjaro as ‘drugs with potential for abuse’ by September, requiring prescription‑only sales and mandatory labeling.
法规动态
2026年9月20日•1 分钟阅读
Seoul Metro faces continued corporate subletting of pharmacy spaces in subway stations
Efforts to block corporate subletting of pharmacy spaces in subway stations have not stopped similar arrangements, prompting the Gangseo‑gu Pharmaceutical Association to request documents from Seoul Metro.
法规动态
2026年9月20日•1 分钟阅读
First Phase of Drug Price Ceiling Reassessment Targets 14,013 Items, 1,576 Excluded
Korea's Health Insurance Review & Assessment Service released a list of 14,013 drugs for price‑ceiling re‑evaluation, excluding 1,576 items, leaving 12,437 for review.
法规动态
2026年9月20日•1 分钟阅读
Korea clarifies that herbal pharmacists cannot dispense prescription drugs in their pharmacies
The Ministry of Health and Welfare confirmed that pharmacies run by hanyaksa are prohibited from preparing prescription medicines and selling OTC drugs.
法规动态
2026年9月20日•1 分钟阅读
Gangseo‑gu Pharmacy Association Calls for Official Review of Balsan Station Medical Zone Lease Bidding
The Gangseo‑gu Pharmacy Association has asked Seoul Metro for an official response and document disclosure regarding the bidding and sub‑lease approval process for pharmacy space in Balsan Station’s Medical Zone.
法规动态
2026年9月20日•1 分钟阅读
Korean Lawmaker Demands Budget Increase for Care Workers' Wages
Lawmaker Jeon Jong-deok and the Korean Confederation of Trade Unions condemned the lack of budget for care‑worker pay and urged the National Assembly to allocate more funds.
法规动态
2026年9月20日•1 分钟阅读
South Korea Approves 44th Domestic New Drug, Latica Eye Drops 5%
MFDS approves Latica Eye Drops 5% for adult dry‑eye patients, marking Korea’s 44th domestically developed new drug and expanding treatment options.