Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
21. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
21. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
21. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
21. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
20. Sept. 2026•1 Min. Lesezeit
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.