Regulatorische Updates

Korea is discussing broader telemedicine drug delivery after a remote prescription of a 60‑day supply of single‑use hyaluronic‑acid eye drops, sparking safety concerns.

The Korean pharmaceutical and biotech sector has secured a limited buffer period as the government delays and adjusts price‑cut criteria for re‑evaluated listed drugs.

The FDA granted approval for ANDA 085231, an oral tablet containing 25 mg pyrilamine maleate, submitted by Watson Labs. The product is listed as discontinued.

Epic Pharma LLC's ANDA076347 for prescription oral tablets of Tizanidine Hydrochloride (2 mg and 4 mg) has been approved by the FDA, with labeling submissions approved between 2007 and 2016.

The FDA has approved ANDA077510 for Colestipol Hydrochloride 1 g tablets, manufactured by Amneal Pharmaceuticals and sponsored by IMPAX Labs.

FDA has approved ZADITOR, an over‑the‑counter ophthalmic solution containing 0.025% ketotifen fumarate (application ANDA077200).

FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.

Lawmaker Kwon Chil‑seung filed an amendment to the Health and Medical Technology Promotion Act to establish a regulatory sandbox for health‑medical innovations.

Lawmakers and the Korean Rare & Intractable Disease Association held a press conference urging that rare disease patients not be sidelined in policy priorities.

An Indonesian BPOM pharmaceutical delegation toured Daewoong Pharmaceutical’s Magok R&D facility, reviewing new‑drug and biopharma projects and discussing joint development and approval pathways in Indonesia.

The domestically developed CAR‑T drug Rimkato (Anbalcapatgen Autolyscel) cleared the drug reimbursement evaluation committee, moving closer to inclusion in national health‑insurance coverage.

The Seoul Pharmacists Association delivered a petition to the National Assembly urging prompt review of pending pharmacist‑related bills and stressing safety checks before expanding telemedicine drug delivery.