規制動向

B. Braun Melsungen AG has informed the MHRA of patient information leaflet errors in certain Meropenem 1000 mg powder and solvent batches.

MHRA published a series of field safety notices between 14‑18 Sep 2026 covering cardiac occluders, circulatory assist catheters, orthopedic instruments, endoscopic needles, imaging systems and diagnostic software.

The MHRA identified signal crossover, erroneous traces and dropouts in wireless cardiotocography systems that use radio‑frequency telemetry.

Martindale Pharmaceuticals reported a linear barcode error affecting certain batches of Clobazam 5 mg/5 mL and 10 mg/5 mL oral suspension (150 mL) to the MHRA.

MHRA reports ongoing fatal and serious harm from patient falls involving hoists or slings, noting an average of two deaths in recent incidents.

MHRA released several Field Safety Notices between 7‑11 September 2026, covering a platelet factor 4‑heparin antibody IVD and an orthopaedic fixation plate among others.

The UK MHRA has decided to withdraw the marketing authorisation for Tavneos (avacopan) for ANCA-associated vasculitis, halting new patient supply from 1 Sept.

MHRA published a series of Field Safety Notices covering devices such as Acu‑Loc 2, bedside monitors, orthopaedic cements and a peripheral artery stent‑graft between 31 Aug and 4 Sep 2026.

The UK Medicines and Healthcare products Regulatory Agency listed several field safety notices for devices such as femoral head adapters, infusion pump cassettes and fluoroscopic X‑ray systems between 24‑28 August 2026.

The MHRA reports that delivering parenteral nutrition without a filter has caused adverse incidents, including a fatal embolism, urging filter use in all care settings.

A brief summary of the MHRA’s latest safety advice for medicines and medical device users.

The MHRA's ninth MedSafety Week runs 4‑10 November 2024, encouraging public reporting of medication safety issues.