法规动态
FDA、EMA、TGA 及全球法规动态
法规动态
2026年9月4日•1 分钟阅读
Daewoong Bio receives 1‑month manufacturing suspension over claim handling lapse
Daewoong Bio was ordered by South Korea’s MFDS to halt production of its 300 mg Icosapent Ethyl soft capsules for one month after failing to process a consumer claim per its own standards.
法规动态
2026年9月4日•1 分钟阅读
Online Sale of Pharmacy‑Only OTC Drugs Triggers Calls for Stricter Regulation
General OTC medicines that should be sold only in pharmacies were found being sold on an online smart store and delivered by courier, prompting renewed calls for tighter online drug distribution controls.
法规动态
2026年9月4日•1 分钟阅读
South Korea Health Ministry Announces Director‑Level and Manager‑Level Personnel Transfers
The Ministry of Health and Welfare issued appointment orders on July 16‑17, 2026, moving senior officials in health industry policy and suicide prevention.
法规动态
2026年9月4日•1 分钟阅读
Kang Cheong-hee appointed Chairman of South Korea's National Health Insurance Service
Kang Cheong-hee, former head of Korea Public Organization Bank, will assume the chairmanship of the National Health Insurance Service on July 20, 2026 for a three‑year term.
法规动态
2026年9月4日•1 分钟阅读
South Korean Lawmaker Introduces Three Bills on Future Security and Public Welfare
Lawyer Baek Seon-hee of the Justice Innovation Party submitted three bills covering national security, illegal drone flights and public welfare.
法规动态
2026年9月4日•1 分钟阅读
Korea Pharmaceutical Safety Agency Highlights Updated Narcotics Regulations at KMA 2026 Conference
The agency announced expanded verification of medical narcotics to include zolpidem and revised safety standards for narcotic analgesics, promoting the changes at the KMA 2026 conference.
法规动态
2026年9月4日•1 分钟阅读
King Pharm Discontinues Quinidine Sulfate Oral Tablet (ANDA 085175)
King Pharm's ANDA 085175 for quinidine sulfate 200 mg oral tablets is listed as discontinued by the FDA.
法规动态
2026年9月4日•1 分钟阅读
FDA Approves Multiple Labeling Updates for Levetiracetam Oral Solution
The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.
法规动态
2026年9月4日•1 分钟阅读
FDA Approves ANDA090572 for Children’s Cetirizine Oral Solutions
FDA approved ANDA090572 submitted by Tris Pharma, covering two discontinued children’s cetirizine hydrochloride oral solutions for allergy and hives relief.
法规动态
2026年9月4日•1 分钟阅读
FDA Approves ANDA090249 for Chloroquine Phosphate Tablet (IPCA Labs) – Now Discontinued
The FDA approved IPCA Labs' ANDA090249 for a 500 mg oral chloroquine phosphate tablet in 2009; the product is currently listed as discontinued.
法规动态
2026年9月4日•1 分钟阅读
FDA Approves ANDA078948 for Ibandronate Sodium Tablet
The FDA has approved ANDA078948 for a prescription oral tablet of Ibandronate Sodium 150 mg, sponsored by Apotex and manufactured by Golden State Medical Supply.
法规动态
2026年9月4日•1 分钟阅读
FDA ANDA080667 Submission for Thiamine Hydrochloride Injection (Discontinued)
The FDA received ANDA080667 from sponsor Luitpold for a thiamine hydrochloride injectable product, listed as discontinued.