Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 28, 2026•1 min read
Korea Korus hit with 1‑month manufacturing suspension over missing post‑marketing safety test
Korea Korus was ordered to halt production of its export‑only recombinant human erythropoietin product for one month after failing to conduct required post‑marketing safety studies.
Regulatory Updates
Sep 28, 2026•1 min read
Busan Offers Up to 320,000 KRW Support for Pharmacies Open on Chuseok
Busan will provide a maximum of 320,000 KRW per pharmacy that remains open on Chuseok day, while Seoul and Jeju have no such grant this year.
Regulatory Updates
Sep 28, 2026•1 min read
KPA to Host 2026 Pharma-Bio Accounting Issues Seminar on Sep 30
The Korea Pharmaceutical & Bio Association will hold a seminar on Sep 30 to discuss 2026 accounting issues and response strategies for pharma‑bio firms, featuring Samjeong KPMG executives.
Regulatory Updates
Sep 28, 2026•1 min read
Seoul Pharmacists Association Calls for Safety‑First Rules on Telemedicine Drug Delivery and Standby Medicine Expansion
Ahead of a national audit, the Seoul City Pharmacists Association urged the National Assembly to prioritize patient safety and strengthen oversight before expanding telemedicine drug delivery and safety‑standby medicines.
Regulatory Updates
Sep 28, 2026•1 min read
NHIS employee suspended for 62 unauthorized personal data accesses
A grade‑5 NHIS staff accessed family and others’ personal data 62 times between Dec 2020 and Nov 2023; a three‑month suspension was imposed in May 2024.
Regulatory Updates
Sep 28, 2026•1 min read
Korean Pharmaceutical Association to Hold Nationwide Rally Against Telemedicine and Prescription Delivery Expansion
The Korean Pharmaceutical Association will host a large rally on June 20 in Gwanghwamun, uniting pharmacists and pharmacy students to oppose the government's telemedicine and prescription‑delivery expansion, while also raising concerns about platform‑driven medical commercialization and health‑insurance financing.
Regulatory Updates
Sep 28, 2026•1 min read
Ministry of Health and Welfare appoints Lee Su-wan as Section Chief of Disability Independence Division
On September 14, 2026, the Ministry of Health and Welfare announced the appointment of Lee Su-wan to the position of Section Chief in the Disability Independence Division.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves ANDA 084469 for Hydralazine Hydrochloride 50 mg Tablet (IVAX Sub Teva Pharm)
The FDA granted approval for ANDA 084469, covering a 50 mg oral tablet of hydralazine hydrochloride submitted by IVAX Sub Teva Pharm. The product is listed as discontinued.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves ANDA083919 for MILTOWN Oral Tablet (Meprobamate 600 mg)
The FDA has approved application ANDA083919 for MILTOWN, an oral tablet containing 600 mg of meprobamate, sponsored by Medpointe Pharm HLC.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Discontinues Hydrocortisone 0.5% Ointment (ANDA084969)
The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Supplemental Approvals for Quinidine Sulfate Oral Tablet
The FDA records show multiple approved supplemental submissions for the discontinued 200 mg oral tablet of quinidine sulfate, covering manufacturing and labeling.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves Manufacturing Supplements for LIORESAL (baclofen) Tablets
The FDA has approved a series of priority manufacturing (CMC) supplement submissions for the discontinued LIORESAL baclofen tablets (10 mg and 20 mg).