規制動向

The government announced a 13.8 trillion KRW national treasury support for 2027 health insurance, but the Health Insurance Labor Union says the increase is insufficient and amounts to a real reduction.

The Korea Disease Control and Prevention Agency announced a 2027 budget of 1.4347 trillion KRW, a 7.4% increase, targeting expanded national immunization, next‑gen vaccines, mRNA and antibody therapeutics, and AI‑driven R&D.

Health Consumer Solidarity says expanding drug delivery for telemedicine must be preceded by a thorough safety and outcome review, prioritizing public health over convenience.

FDA's ANDA 084640 for DIPHEN oral elixir, containing diphenhydramine hydrochloride 12.5 mg/5 mL, was approved for USL Pharma with multiple manufacturing supplements; the product is now discontinued.

Watson Labs' diphenhydramine hydrochloride injectable (product 001) is recorded by the FDA under ANDA083533 as discontinued and not a reference drug.

The FDA has granted approval (ANDA081213) for Watson Labs' ESTROPIPATE 0.75 mg oral tablet, with several labeling and manufacturing submissions approved.

The FDA approved ANDA089706 for a topical hydrocortisone 1% cream submitted by NASKA. The product is listed as discontinued.

South Korea’s MFDS announced a 2027 budget of 8.829 billion KRW, focusing on AI‑based drug approval, global regulatory assistance, and a state‑run stockpile for essential medicines.

The FDA’s ANDA089313 for CHORIONIC GONADOTROPIN injection by Quad Pharm is listed as discontinued.

The FDA approved ANDA084144 for a 0.5% proparacaine hydrochloride ophthalmic solution (drops) submitted by SOLA BARNES HIND; the product is now discontinued.

The FDA granted approval (AP) for ANDA 088932 submitted by IVAX PHARMS for an oral tablet containing 0.125 mg reserpine and 50 mg hydroflumethiazide; the product is listed as discontinued.

대한약사회는 31일 긴급 상임이사회에서 국민건강권 사수 비상대책위원회(가칭) 구성을 심의·의결하고, 연제덕·김성진·최종석 등을 위원장 후보로 선정했다.