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法规动态

FDA、EMA、TGA 及全球法规动态

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法规动态
2026年9月18日•1 分钟阅读
FDA Approves ANDA077826 for Fenoldopam Mesylate Injection
The FDA has approved an Abbreviated New Drug Application (ANDA077826) for fenoldopam mesylate injection submitted by Teva Parenteral.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
FDA Approves Teva Olanzapine/Fluoxetine Combination (ANDA077528)
FDA has approved Teva Pharmaceuticals' ANDA077528 for an oral capsule combining olanzapine and fluoxetine, with several dosage strengths, as of Feb 26 2021.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
FDA Approves ANDA077222 for Fosinopril Sodium Tablets
The FDA has approved ANDA077222 for generic fosinopril sodium oral tablets in 10 mg, 20 mg, and 40 mg strengths, sponsored by Invagen Pharms.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
Lawmaker Introduces Bills to Make Caregiving Costs Tax‑Deductible and Covered by Medical Aid
A Democratic Party MP proposes amending the Medical Aid, National Health Insurance and Inheritance Tax laws to subsidize caregiving expenses and allow deductions from inherited estates.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
Seongnam Pharmacists Association Holds 2026 Training Session
The Seongnam Pharmacists Association completed its 2026 training program at Seoul National University Hospital, covering six credits and addressing online drug delivery concerns.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
Health Canada Warns of Counterfeit Soprano Laser Hair Removal Devices
Health Canada alerts that counterfeit Soprano laser hair removal machines, made by Beijing Perfectlaser, are being sold to Canadian clinics, posing health risks.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
Health Canada Warns of Counterfeit Soprano Laser Hair Removal Devices Sold to Canadian Clinics
Health Canada alerts that counterfeit laser hair removal devices marketed as “Soprano” are being sold to clinics in Canada, posing health risks and violating regulations.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
KMA urges balanced 2027 health insurance contribution rate at policy review
The Korean Medical Association calls for a fiscally sustainable 2027 health insurance premium rate as the 15th Health Insurance Policy Review Committee meets on the 8th.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
MFDS Announces Personnel Transfers and Promotions
The Ministry of Food and Drug Safety announced several staff transfers and promotions on Sep 4 and Sep 7, 2026, covering food safety, consumer protection and bio‑pharmaceutical divisions.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
FDA Approves Levetiracetam (ANDA076920)
The FDA has approved ANDA076920 for Levetiracetam tablets (250 mg, 500 mg, 750 mg) manufactured by Dr. Reddy's Laboratories and sponsored by Pharmazone.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
FDA Approves Carvedilol Generic (ANDA 076649) by Dr. Reddy's Laboratories
FDA granted approval for ANDA 076649, a carvedilol oral tablet generic from Dr. Reddy's Laboratories, covering four strengths and prescription use.
UPDATED
法规动态
2026年9月18日•1 分钟阅读
FDA Grants Approval for AdaRe Pharm’s Potassium Chloride Extended‑Release Tablets (ANDA 076368)
The FDA approved ANDA 076368 for two extended‑release potassium chloride tablets (10 mEq and 20 mEq) marketed by AdaRe Pharm and manufactured by Sun Pharmaceutical.