규제 업데이트

Medtronic reports a variation in the reflective coating of certain sterile passive spheres, which could affect instrument detection and tracking during navigation procedures.

The Korean Pharmaceutical Association warns the government’s proposal to extend prescription drug delivery to all telemedicine patients will require legal changes and vows to block it.

The Korean Pharmacists Association urges the government to halt plans to broaden prescription drug delivery to all telemedicine patients, citing legal limits and the need for law amendment.

On September 7, 2026, the Ministry announced the promotion of Han Young-gyu to manager‑level head of the Medical Institution Policy Division.

Lawmaker Lee Kwang‑hee introduced five amendment bills to reduce the three‑year mandatory service for qualified health personnel, aligning it closer to the 18‑month term for regular soldiers.

Analysis shows 82% of the Ministry’s 177 websites and apps are accessibility certified, leaving 18% uncertified as of August 2026.

The FDA record for NDA 018817 lists multiple labeling and manufacturing submissions for CALAN verapamil tablets, all currently marked as discontinued.

Health Canada has recalled Platinum Naturals Easymulti Stress (Men) capsules (lots 737‑737C) due to incorrect Vitamin B6 labeling. Retailers should remove affected products.

The FDA has approved Eli Lilly’s Humulin R injectable insulin products, including OTC and prescription formulations, under application BLA018780.

MHRA reports ongoing fatal and serious harm from patient falls involving hoists or slings, noting an average of two deaths in recent incidents.

Pharmacies report that health‑insurance claim software experiences delays and network errors at month‑end due to overload of the HIRA medical‑claim portal server.

The FDA has approved ANDA091665 for ARGATROBAN injection, a prescription anticoagulant submitted by PH HEALTH.