法规动态
FDA、EMA、TGA 及全球法规动态
法规动态
2026年8月24日•1 分钟阅读
Potential Pulmonary Aspiration Risk with GLP-1 Agonists During Anaesthesia
Healthcare professionals warned of pulmonary aspiration risk in patients on GLP-1 or dual GIP/GLP-1 agonists undergoing general anaesthesia or deep sedation.
法规动态
2026年8月24日•1 分钟阅读
CHM Removes Specialist Review for Men Already on Valproate, Retains for New Patients Under 55
The Commission on Human Medicines says men already taking valproate no longer need a specialist review, while the requirement stays for patients under 55 starting the drug.
法规动态
2026年8月24日•1 分钟阅读
PMCPA Rebukes Alnylam After Pfizer Complaint; UK Watchdog Overturns
Pfizer complained about Alnylam’s promotional activities at a cardiology congress, prompting the PMCPA to criticize the biotech, but the UK marketing watchdog later reversed its harshest finding on appeal.
法规动态
2026年8月24日•1 分钟阅读
US Launches Probe into Germany's Alleged Underpayment for New Medicines
The United States is investigating Germany over what the USTR calls persistent underpayment for new pharmaceuticals amid German drug‑spending reforms.
法规动态
2026年8月24日•1 分钟阅读
Korean Pharmacists Hold 273rd Relay Protest for Herbal Pharmacist Licensing Reform
The Korean Pharmaceutical Association and regional pharmacy societies held the 273rd relay protest in front of the Blue House, urging the government and parliament to amend the Pharmacy Act and define clear licensing for herbal pharmacists.
法规动态
2026年8月24日•1 分钟阅读
MFDS proposes label changes for 134 dapagliflozin/metformin combo products
South Korea's MFDS has drafted an amendment to approval conditions for 134 dapagliflozin‑metformin combination drugs, seeking public comments to unify efficacy, dosage and safety guidance.
法规动态
2026年8月24日•1 分钟阅读
FDA Approves ANDA077168 for Fluticasone Propionate Topical Ointment by Cosette Pharmaceuticals
The FDA has approved ANDA077168 for a prescription topical ointment containing 0.005% fluticasone propionate, manufactured by Cosette Pharmaceuticals.
法规动态
2026年8月24日•1 分钟阅读
FDA Approves ANDA076877 for Gabapentin Tablets (Discontinued)
FDA approved ANDA076877 for gabapentin 600mg and 800mg oral tablets submitted by Senores Pharms; both products are listed as discontinued.
法规动态
2026年8月24日•1 分钟阅读
FDA Grants ANDA Approval for Ciprofloxacin Hydrochloride Tablets (ANDA 076593)
The FDA approved generic ciprofloxacin hydrochloride tablets (250 mg, 500 mg, 750 mg) under ANDA 076593, sponsored by Aiping Pharm and manufactured by Westminster Pharmaceuticals.
法规动态
2026年8月24日•1 分钟阅读
Recall: Ifosfamide IV Vials Not Refrigerated at Amerisource Bergen Distribution Centers
Certain vials of Ifosfamide IV were found to have been stored without refrigeration at Amerisource Bergen distribution centers, prompting a recall.
法规动态
2026年8月24日•1 分钟阅读
FDA Recalls Product Due to CGMP Deviations
The FDA has initiated a recall of a product because of deviations from current Good Manufacturing Practices (CGMP).
法规动态
2026年8月24日•1 分钟阅读
MHRA Publishes Summary of Recent Medicine and Device Safety Letters
The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.