규제 업데이트

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.

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.

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.

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.

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.

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.

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.

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.

The FDA has approved application ANDA083919 for MILTOWN, an oral tablet containing 600 mg of meprobamate, sponsored by Medpointe Pharm HLC.

The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.

The FDA records show multiple approved supplemental submissions for the discontinued 200 mg oral tablet of quinidine sulfate, covering manufacturing and labeling.

The FDA has approved a series of priority manufacturing (CMC) supplement submissions for the discontinued LIORESAL baclofen tablets (10 mg and 20 mg).