규제 업데이트
FDA, EMA, TGA 및 글로벌 규제 동향
규제 업데이트
2026년 9월 13일•1분 읽기
South Korean Government Sets 2027 Health Insurance Treasury Support at 13.8 trillion KRW, Union Claims Effective Cut
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.
규제 업데이트
2026년 9월 13일•1분 읽기
Korea Disease Control Agency Allocates 1.435 trillion KRW for 2027 Budget, Expands Vaccine and AI R&D Funding
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.
규제 업데이트
2026년 9월 13일•1분 읽기
Consumer group urges safety review of telemedicine drug delivery
Health Consumer Solidarity says expanding drug delivery for telemedicine must be preceded by a thorough safety and outcome review, prioritizing public health over convenience.
규제 업데이트
2026년 9월 13일•1분 읽기
FDA Approves ANDA 084640 for DIPHEN Oral Elixir (USL Pharma)
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.
규제 업데이트
2026년 9월 13일•1분 읽기
FDA Lists Diphenhydramine Hydrochloride Injection (ANDA083533) as Discontinued
Watson Labs' diphenhydramine hydrochloride injectable (product 001) is recorded by the FDA under ANDA083533 as discontinued and not a reference drug.
규제 업데이트
2026년 9월 13일•1분 읽기
FDA Approves ANDA081213 for ESTROPIPATE Oral Tablet
The FDA has granted approval (ANDA081213) for Watson Labs' ESTROPIPATE 0.75 mg oral tablet, with several labeling and manufacturing submissions approved.
규제 업데이트
2026년 9월 13일•1분 읽기
FDA Approves ANDA089706 for Hydrocortisone 1% Cream – Discontinued
The FDA approved ANDA089706 for a topical hydrocortisone 1% cream submitted by NASKA. The product is listed as discontinued.
규제 업데이트
2026년 9월 13일•1분 읽기
MFDS Sets 2027 Budget of 8.8 bn KRW, Emphasizes AI‑Driven Drug Approval and Global Regulatory Support
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.
규제 업데이트
2026년 9월 13일•1분 읽기
FDA Lists ANDA089313 for Chorionic Gonadotropin Injection (Discontinued)
The FDA’s ANDA089313 for CHORIONIC GONADOTROPIN injection by Quad Pharm is listed as discontinued.
규제 업데이트
2026년 9월 13일•1분 읽기
FDA Approves ANDA084144 for Proparacaine Hydrochloride Ophthalmic Solution
The FDA approved ANDA084144 for a 0.5% proparacaine hydrochloride ophthalmic solution (drops) submitted by SOLA BARNES HIND; the product is now discontinued.
규제 업데이트
2026년 9월 13일•1분 읽기
FDA Approves Reserpine and Hydroflumethiazide Tablet (ANDA 088932)
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.
규제 업데이트
2026년 9월 13일•1분 읽기
대한약사회, 국민건강권 사수 비상대책위원회 구성 결의
대한약사회는 31일 긴급 상임이사회에서 국민건강권 사수 비상대책위원회(가칭) 구성을 심의·의결하고, 연제덕·김성진·최종석 등을 위원장 후보로 선정했다.