규제 업데이트

The CHM has temporarily restricted the IXCHIQ Chikungunya vaccine for people aged 65 and older after very rare fatal reactions were reported globally.

A counterfeit tirzepatide (Mounjaro) KwikPen 15 mg batch D873576 was identified from a UK online pharmacy, prompting a safety alert.

MHRA warns that nasal decongestant sprays containing xylometazoline or oxymetazoline can cause rebound congestion when their effect wears off.

The UK regulator advises new measures to reduce suicide risk linked to finasteride and dutasteride.

Amiodarone linked to life‑threatening lung, liver and thyroid side effects; MHRA urges healthcare professionals to supervise and review patients.

Healthcare professionals warned of delayed angioedema onset and need to differentiate bradykinin‑ and histamine‑mediated cases, as treatments differ.

The UK Medicines and Healthcare products Regulatory Agency reports cases of iatrogenic botulism after therapeutic or cosmetic use of botulinum toxin type‑A, urging immediate medical attention if symptoms arise.

MHRA updates domperidone product information to contraindicate use in confirmed or suspected pheochromocytoma due to severe hypertension risk.

The Pharmaceuticals and Medical Devices Agency (PMDA) issued a safety alert warning that using insulin‑specific syringes incorrectly may cause serious adverse health effects.

The Pharmaceuticals and Medical Devices Agency announced that PDG harmonized texts have been incorporated into updated Japanese Pharmacopoeia monographs.

PMDA has refreshed its ATC learning video series, providing updated educational content for pharmaceutical professionals.

The PMDA published seven English translations of notifications and administrative notices related to pediatric drug development, including a revision of the planning guidance for adult drug programs.