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Four medicine safety updates from MHRA, Ukraine, Medsafe and NMPA

  • 30-09-2026
  • Posted by: Eldaniz Hasanov
  • Category: Regulatory Updates
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On 30 September 2026, PharmExpert identified four new or revised official medicine-safety materials published after the previous checkpoint.

For QPPV, LQPPV and LPPV professionals, these signals may be relevant to local risk assessment, regulatory obligation checks and updates to internal pharmacovigilance procedures.

MHRA: September Safety Roundup

MHRA covered filters for parenteral nutrition after adverse incidents including a fatal embolism; syncope after Fluenz; anaphylaxis after intra-articular corticosteroids; and potentially falsely elevated digoxin results with CMIA in patients receiving apalutamide or enzalutamide. MHRA source.

Ukraine: dexmedetomidine

The Ukraine SEC reported that in SPICE III (3,904 ICU patients), dexmedetomidine in patients aged ≤65 was associated with increased mortality: RR 1.26; 95% CI 1.02–1.56. Product information is being updated. Ukraine SEC source.

Medsafe: GLP-1 receptor agonists and visual loss

Medsafe assessed four reports, including NAION, updated datasheets and maintained a positive benefit-risk assessment. Medsafe source.

NMPA/CDE: ADHD stimulants and Injectafer

Drug Vigilance Express issue 9 (281) describes 14 Health Canada reports of weight loss in children under six using ADHD stimulants and the FDA boxed warning for Injectafer on symptomatic hypophosphataemia, osteomalacia and fractures. NMPA/CDE source.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official communications issued by MHRA, the State Expert Center of the Ministry of Health of Ukraine, Medsafe and NMPA/CDE and current as of 30 September 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by any manufacturer/marketing authorisation holder or a quality concern affecting a company’s entire product portfolio. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary sources, the regulators’ instructions and the approved product information.