규제 업데이트
FDA, EMA, TGA 및 글로벌 규제 동향
규제 업데이트
2026년 9월 9일•1분 읽기
Seoul Pharmacists Association Schedules Emergency Meeting on Telemedicine Delivery and Pharmacy Regulations
The Seoul Pharmacists Association will hold an emergency general meeting on Sept 5 to discuss expanding drug delivery for telemedicine, safety‑stock medicine changes, and the rise of warehouse pharmacies.
규제 업데이트
2026년 9월 9일•1분 읽기
Parliamentarians Host Policy Forum on Bio‑Data Platform Activation
A policy forum on activating bio‑data utilization platforms was held on Aug 28 at the National Assembly, organized by the Korean Medical Data Association and the Korea Industry Federation Forum, with participation from lawmakers and industry leaders.
규제 업데이트
2026년 9월 9일•1분 읽기
Mylan's Chlordiazepoxide Hydrochloride Oral Capsule (ANDA 084887) Discontinued
Mylan's oral capsule product containing 25 mg chlordiazepoxide hydrochloride (product 001) is listed as discontinued. The ANDA includes four manufacturing (CMC) submissions approved on June 10 1981.
규제 업데이트
2026년 9월 9일•1분 읽기
FDA Approves Sodium Chloride Injection (NDA018090)
The FDA has approved NDA018090 for Sodium Chloride 0.45% injectable, manufactured by ICU Medical Inc.
규제 업데이트
2026년 9월 9일•1분 읽기
JoA Pharmaceutical Reintroduces Gareo-Aq Digestive Medicine After 3-Year Clinical Reassessment
JoA Pharmaceutical has re‑launched its OTC digestive aid Gareo‑Aq, featuring DHBE, after completing a three‑year clinical re‑evaluation across six Korean medical centers.
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2026년 9월 9일•1분 읽기
MFDS revises GIFT review guidelines to include patient experience for rare disease drugs
South Korea's MFDS updated its GIFT fast‑track review criteria on March 28, adding patient real‑world experience to priority assessment for innovative rare‑disease therapies.
규제 업데이트
2026년 9월 9일•1분 읽기
FDA Approves ANDA090018 for ZoleDRonic Acid Injectable (Discontinued)
Sun Pharma Global received FDA approval (ANDA090018) for a 4 mg/vial intravenous ZoleDRonic Acid injectable, currently listed as discontinued.
규제 업데이트
2026년 9월 9일•1분 읽기
FDA Approves ANDA089116 for BROMPHERIL Extended-Release Tablet
FDA approved ANDA089116 for BROMPHERIL, an oral extended-release tablet containing 6 mg dexbrompheniramine maleate and 120 mg pseudoephedrine sulfate, submitted by Copley Pharm; product is listed as discontinued.
규제 업데이트
2026년 9월 9일•1분 읽기
FDA Submissions for Sublingual Buprenorphine Hydrochloride Tablets (Products 001 & 002)
FDA records show two discontinued sublingual buprenorphine tablet products with multiple approved labeling and REMS submissions spanning 2010‑2026.
규제 업데이트
2026년 9월 9일•1분 읽기
FDA Approves ANDA089479 for Acetaminophen/Codeine Phosphate Tablet (Discontinued)
The FDA granted approval for ANDA089479, submitted by AM THERAP, for an oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate. The product is listed as discontinued.
규제 업데이트
2026년 9월 9일•1분 읽기
FDA Approves ANDA 079054 for Alfuzosin Hydrochloride Extended‑Release Tablet
FDA granted labeling approvals for Torrent Pharm's discontinued Alfuzosin Hydrochloride 10 mg extended‑release tablet (ANDA 079054).
규제 업데이트
2026년 9월 9일•1분 읽기
FOSPHENYTOIN SODIUM (ANDA078736) FDA Approval
FDA approves the original ANDA and multiple labeling supplements for fosphenytoin sodium injection (product 001) by Pharmobedient.