規制動向
FDA、EMA、TGA および世界の規制動向
規制動向
2026年8月23日•1分で読めます
Beckman Coulter iQ200 and DxU 840m/850m Analyzers Report Fluid Leak Complaints
Customer complaints indicate lamina fluid leaks in iQ200 Series and DxU 840m/850m analyzers due to a compromised rinse-line check valve.
規制動向
2026年8月23日•1分で読めます
Health Canada Alert: Aisys™ Anesthesia Systems to Alternate O₂ Control
Health Canada alerts that Aisys™ Carestation™, Aisys™ CS² and CS² with Et Control anesthesia systems may automatically switch to Alternate O₂ Control due to certain electronic gas mixer assemblies.
規制動向
2026年8月23日•1分で読めます
Becton Dickinson UK recalls ChloraPrep 2% applicators over sterility concerns
Becton Dickinson UK Ltd is recalling batches of ChloraPrep 2% 1 mL and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential sterility breach in packaging.
1
規制動向
2026年8月23日•1分で読めます
Teva UK reports labeling error on Ponlimsi (Denosumab) 60mg carton
Teva UK Limited has identified a labeling mistake on the Ponlimsi (Denosumab) 60 mg pre‑filled syringe carton, which incorrectly states “For application to the skin” despite the product being licensed for subcutaneous injection.
規制動向
2026年8月23日•1分で読めます
MHRA publishes Field Safety Notices for 18‑22 May 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering 18‑22 May 2026.
規制動向
2026年8月23日•1分で読めます
Cadila Pharmaceuticals reports barcode error on Mirtazapine 30mg tablets
Cadila Pharmaceuticals notified the MHRA of an incorrect EAN barcode on cartons of a batch of Mirtazapine 30mg film-coated tablets distributed by Crescent Pharma.
規制動向
2026年8月23日•1分で読めます
MHRA Issues Field Safety Notices for 15‑19 June 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering the period 15 to 19 June 2026.
規制動向
2026年8月23日•1分で読めます
Brancaster Pharma reports outdated PIL on notified batches
Brancaster Pharma informed the MHRA that cartons for the listed batches were supplied with an outdated Patient Information Leaflet.
規制動向
2026年8月23日•1分で読めます
Flamingo Pharma UK Ltd recalls Flucloxacillin 500mg capsules due to incorrect PIL
Flamingo Pharma UK Ltd notified the MHRA that some packs of Flucloxacillin Capsules BP 500 mg were supplied with the Patient Information Leaflet for Amoxicillin 500 mg, prompting a recall.
規制動向
2026年8月23日•1分で読めます
MHRA Publishes Field Safety Notices for 29 June–3 July 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of field safety notices covering drugs and devices from 29 June to 3 July 2026.
規制動向
2026年8月23日•1分で読めます
MHRA Issues July 2026 Safety Advice for Medicines and Medical Devices
The UK Medicines and Healthcare products Regulatory Agency released its July 2026 safety roundup, highlighting recent advice for medicines and medical device users.
規制動向
2026年8月23日•1分で読めます
MHRA publishes Field Safety Notices for 27‑31 July 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering 27 to 31 July 2026.