Regulatory Updates
Sep 10, 2026•1 min read
Korean Health Insurance Drug List Shrinks, OTC Items Decline Faster Than Prescription
The number of drugs covered by Korea’s health insurance has fallen steadily, with over‑the‑counter medicines dropping 25.2% over five years—more sharply than prescription drugs.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA089116 for BROMPHERIL Extended-Release Tablet
FDA approved ANDA089116 for BROMPHERIL, an oral extended-release tablet containing 6 mg dexbrompheniramine maleate and 120 mg pseudoephedrine sulfate, submitted by Copley Pharm; product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
South Korea cracks down on illegal sale of imported medicines in traditional market stalls
A joint inspection by South Korea’s MFDS and local governments uncovered 30 import stalls illegally selling overseas OTC and psychotropic medicines in traditional markets.
Regulatory Updates
Sep 7, 2026•1 min read
Amgen Korea’s Blincyto Gains Health‑Insurance Coverage for Ph‑Negative B‑Cell ALL in Sep 2024
From September, Blincyto (blinatumomab) will be reimbursed for Ph‑negative CD19‑positive precursor B‑cell ALL patients aged ≥1 year who achieve MRD‑negative remission.
Regulatory Updates
Sep 5, 2026•1 min read
Ewha Pharmacy Alumni Association adopts resolution on safe medication use
The alumni group held its Aug 22 meeting, discussing OTC expansion, relaxed sales rules in drug‑free zones, and telemedicine‑driven delivery, and adopted a safety‑focused resolution.
Regulatory Updates
Sep 5, 2026•1 min read
Korean Government Considers Expanding Telemedicine Drug Delivery, Legislative Review Ongoing
Debate continues on whether to discuss further regulatory improvements for telemedicine‑based medication delivery before the system is launched, highlighting the need for legislative action.
Regulatory Updates
Sep 2, 2026•1 min read
Korea Adjusts Drug Distribution Reporting Deadline Due to Constitution Day Holiday
The Korean Pharmaceutical Management Center has shifted the reporting deadline for specialized drug shipments scheduled between Sep 16‑19 to Sep 20, due to the re‑designated Constitution Day holiday on Sep 17.
Regulatory Updates
Sep 2, 2026•1 min read
Samchundang Pharma receives manufacturing suspension over test record violations and recall plan failure
Samchundang Pharmaceutical was ordered to halt production after the MFDS found irregularities in a potency test and a failure to submit a recall plan for its contracted Lefurozin syrup.
Regulatory Updates
Sep 1, 2026•1 min read
Bonofrazan Fumarate Enters Korean Health Insurance Price Negotiations Alongside Original Product
Bonofrazan fumarate, a P‑CAB ulcer medication, has begun price negotiations with Korea’s Health Insurance Review & Assessment Service, drawing industry attention to potential patent and reimbursement impacts.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Discontinues ANDA089249 for NANDROLONE DECANOATE Injection
The FDA has listed the ANDA089249 application for NANDROLONE DECANOATE injectable by Quad Pharms as discontinued, noting its marketing status and product details.
Regulatory Updates
Aug 30, 2026•1 min read
TABLICAPS Submits ANDA084632 for Discontinued Oral Aminophylline 100 mg Delayed‑Release Tablet
TABLICAPS has filed ANDA084632 for an oral aminophylline 100 mg delayed‑release tablet, currently listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
Korean Pharmaceutical Association Calls for Mandatory Reporting of Human Drugs Used in Veterinary Clinics
The Korean Pharmaceutical Association urges amendment of the Veterinarian Act to require veterinarians and animal hospitals to report usage of human prescription drugs, citing limits of the current pharmacy sales reporting system.