Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Stryker LifePak R-35 Monitor-Defibrillator May Have Improperly Seated Connectors
Stryker discovered that some LifePak R-35 units may have printer and modem access port connectors not fully seated, potentially appearing flush or recessed.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
New Minimum Wage Bills Target Small Businesses, May Affect Pharmacies
Bills to adjust minimum wage based on business size and to support at‑risk small retailers have been introduced, raising questions about impacts on Korean pharmacies.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
GSK's Depemokimab Fails Korean Orphan‑Drug Review Over Efficacy Concerns
GSK's depemokimab for severe eosinophilic asthma was denied orphan‑drug status in Korea due to insufficient efficacy or safety advantage over existing biologics.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Boston Scientific Initiates Recall of Imager II Angiographic Catheters Over Tip Issue
Boston Scientific is recalling Imager II Angiographic Catheters after discovering reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Boston Scientific Initiates Recall of Imager II Angiographic Catheters
Boston Scientific is recalling Imager II catheters due to reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Gore Reports Quality Issue with VIABAHN® Devices Potentially Affecting Tip Bonding
Gore discovered some VIABAHN® devices were processed on equipment outside the validated range, potentially causing incorrect distal tip bonding.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Gore VIABAHN® Device Quality Issue Identified
Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
KADA Receives First ‘Excellent (A)’ Rating in 2025 Public Institution Management Evaluation
The Korea Anti-Doping Agency (KADA) earned an ‘Excellent (A)’ rating for the first time since its establishment in the 2025 Ministry of Culture, Sports and Tourism management performance review.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Pharmacists and Students Hold 301‑Day Relay Protest at Cheong Wa Dae Over Han Yaksa Issues
On the 301st day of the relay protest, the Jeonbuk Pharmacists Association and pharmacy students gathered at Cheong Wa Dae demanding swift government and parliamentary action on Han Yaksa concerns.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
KPA Marks 300 Days of Protest Over Herbal Pharmacist Licensing
The Korean Pharmacists Association held its 300‑day rally, urging the government and parliament to resolve the licensing system for herbal pharmacists and fulfill promises on Korean medicine segregation.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Dongguk Pharmaceutical's Rosutanmet Tablets Lose Health Insurance Coverage After Approval Cancellation
Two Dongguk Pharmaceutical Rosutanmet tablet products (500/5 mg and 500/10 mg) will have health‑insurance reimbursement stopped from the 28th after the Daejeon regional authority cancelled their approvals.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Korea Pushes Pharmacy Law Amendment to Block External Capital in Pharmacies
A draft amendment to the Pharmacy Act seeks to prevent external capital from managing pharmacies, with calls to speed up enactment and apply it retroactively to existing stores.