規制動向

Healthcare professionals warned of pulmonary aspiration risk in patients on GLP-1 or dual GIP/GLP-1 agonists undergoing general anaesthesia or deep sedation.

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.

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.

The United States is investigating Germany over what the USTR calls persistent underpayment for new pharmaceuticals amid German drug‑spending reforms.

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.

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.

The FDA has approved ANDA077168 for a prescription topical ointment containing 0.005% fluticasone propionate, manufactured by Cosette Pharmaceuticals.

FDA approved ANDA076877 for gabapentin 600mg and 800mg oral tablets submitted by Senores Pharms; both products are listed as discontinued.

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.

Certain vials of Ifosfamide IV were found to have been stored without refrigeration at Amerisource Bergen distribution centers, prompting a recall.

The FDA has initiated a recall of a product because of deviations from current Good Manufacturing Practices (CGMP).

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.