규제 업데이트

The Korean Legislative Research Service flagged essential drug shortages as a key health‑welfare issue in its 2026 National Audit analysis, noting gaps between existing plans and a lack of a health‑security control tower.

The Korean government postponed the price reduction for high‑priority listed medicines to April 2025, while confirming September 1 2024 as the reference date for calculating new prices.

The FDA cleared 26 new drugs in the first half of 2026, emphasizing a shift to oral treatments and novel modalities like PROTACs, with oncology and neurology leading indications.

Following a high‑profile drowsy‑driving case, South Korea revised its law in April 2026, raising penalties to up to 5 years imprisonment or 20 million KRW fine and stressing pharmacy drowsiness warnings.

The FDA has approved ANDA 076392 for Mefloquine Hydrochloride oral tablets (250 mg) manufactured by Teva Pharmaceuticals, sponsor BARR.

FDA approved ANDA080807 submitted by IMPAX Labs for oral diphenhydramine hydrochloride capsules (25 mg and 50 mg). Both products are listed as discontinued.

FDA records indicate Marshall Pharma's oral prednisone 5 mg tablet (product 001) under application ANDA080301 is listed as discontinued.

The FDA approved GYNE-LOTRIMIN, a clotrimazole 1% vaginal cream, in 1978 and issued multiple manufacturing and labeling supplements thereafter; the product is now discontinued for non‑safety reasons.

The FDA records show PAMELOR oral solution (nortriptyline hydrochloride) is discontinued, with a history of labeling and manufacturing submissions from 1977 to 2014.

The Seoul City Pharmacists Association will hold its 2026 temporary delegate general meeting on Sept 5, 2026, to discuss delegate elections, telemedicine, safety‑stock medicines, and pharmacy market issues.

The FDA has approved the prescription drug Sorbitol-Mannitol (NDA018316), a urethral irrigation solution containing mannitol and sorbitol, manufactured by ICU Medical Inc.

The Guro‑gu Pharmaceutical Association criticized the government’s plan to broadly expand prescription drug delivery for telemedicine patients, urging adherence to existing principles and pharmacist oversight.