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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA212652 for Esomeprazole Magnesium Delayed‑Release Oral Suspension
The FDA has approved Torrent Pharmaceuticals' generic esomeprazole magnesium delayed‑release oral suspension (ANDA212652), a prescription oral drug with 10 mg base per packet.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Korean Pharmacists Association Plans Nationwide Rally to Oppose Telemedicine and Drug Delivery Expansion
The Korean Pharmacists Association held its first strategy meeting to plan a September 20 nationwide rally, focusing on protecting public health rights and opposing the expansion of telemedicine and drug delivery services.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
MFDS Reaffirms Strict Evidence Standards for Health Functional Food Ingredients
MFDS says statistical significance alone isn’t enough for functional food ingredient approval; proper trial design and consistent functional outcomes are required.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA091667 for MISOPROSTOL Oral Tablets (Discontinued)
The FDA approved application ANDA091667 for oral MISOPROSTOL tablets (0.1 mg and 0.2 mg) from Novel Labs, though both products are listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Korean pharma firms detect illegal online sales of OTC medicines on e‑commerce site
Pharma companies in Korea have identified abnormal distribution of their OTC drugs on an online shopping mall that also sells supplements and masks, prompting a response to curb illegal sales.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Chartwell Rx Receives FDA Approval for TRAVOPROST Ophthalmic Solution (ANDA091340)
The FDA has approved Chartwell Rx's ANDA091340 for the ophthalmic solution TRAVOPROST (0.004%) as a prescription product.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Korean Pharmacist Society Mobilizes Against Expanded Telemedicine Prescription Delivery
The Korean pharmacist community is launching a full‑scale campaign against the government's plan to broaden delivery of prescription drugs for telemedicine, with the Korean Pharmaceutical Association forming an emergency task force.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA083784 for Meclizine Hydrochloride 12.5 mg Tablet
The FDA approved ANDA083784 for a 12.5 mg oral Meclizine Hydrochloride tablet submitted by IVAX Sub Teva Pharm; the product is currently listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA 080784 for PurePac Pharm Folic Acid Tablet
FDA has approved an ANDA for a 1 mg oral folic acid tablet submitted by PurePac Pharm; the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
DIPHENHYDRAMINE HYDROCHLORIDE
FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA080279 for Prednisone 5mg Tablet by Inwood Labs
The FDA approved ANDA080279 for a 5 mg oral prednisone tablet submitted by Inwood Labs; the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Grants ANDA079044 Approval for Nicotine Polacrilex Chewing Gum (OTC)
The FDA approved ANDA079044 for a nicotine polacrilex chewing gum marketed as an over‑the‑counter product, with multiple manufacturers listed.