Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
Gore VIABAHN® Device Quality Issue Identified
Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.
Regulatory Updates
Sep 4, 2026•1 min read
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.