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
MHRA Publishes Field Safety Notices on 1 May 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices on 1 May 2026.
規制動向
2026年8月23日•1分で読めます
Milpharm Limited reports discrepancy in PIL for Loperamide 2 mg Orodispersible Tablets
Milpharm Limited has found a discrepancy in the approved Patient Information Leaflet for its 2 mg Loperamide hydrochloride orodispersible tablets.
規制動向
2026年8月23日•1分で読めます
MHRA Publishes Field Safety Notices for 4–8 May 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering the period 4 to 8 May 2026.
規制動向
2026年8月23日•1分で読めます
MHRA Publishes Field Safety Notices for 27 April–1 May 2026
The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a list of Field Safety Notices issued between 27 April and 1 May 2026.
規制動向
2026年8月23日•1分で読めます
Fresenius Medical Care Deutschland GmbH Reports Braille Label Error
Fresenius Medical Care Deutschland GmbH identified an error in the Braille printing on the outer label of its product, as noted in an MHRA alert.
規制動向
2026年8月23日•1分で読めます
Risk of Severe Harm from Using Incorrect IV Giving Set for Blood Transfusion
Using an IV infusion giving set instead of a blood transfusion set may cause serious patient harm.
規制動向
2026年8月23日•1分で読めます
MHRA Issues Field Safety Notices for 11‑15 May 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering the period 11‑15 May 2026.
規制動向
2026年8月23日•1分で読めます
Medline and Kimal Issue Field Safety Notices for Namic Syringes and Manifolds
Medline Industries and Kimal PLC have reported safety concerns with Namic Angiographic Control Syringes and White Star Off‑Handle Manifold devices, issuing field safety notices to UK hospitals.
規制動向
2026年8月23日•1分で読めます
MHRA Alerts on Rare Complications from Allurion Gastric Balloon
The MHRA reports rare cases where the Allurion Gastric Balloon failed to transit, causing gastric outlet obstruction, small bowel obstruction, or gastric perforation.
規制動向
2026年8月23日•1分で読めます
Crescent Pharma Initiates Precautionary Recall of Ramipril 2.5 mg Capsules
Crescent Pharma Limited is recalling a batch of 2.5 mg Ramipril capsules due to a possible packaging error.
規制動向
2026年8月23日•1分で読めます
MHRA releases Field Safety Notices for 25‑29 May 2026
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a list of field safety notices covering the period 25 to 29 May 2026.
1
規制動向
2026年8月23日•1分で読めます
Health Canada Recall: Inaccurate StO2 Readings from Edwards ForeSight™ Oximeter Cable
Edwards reports mislabelled sensor cables on the ForeSight™ Oximeter Cable may cause swapped left/right StO2 values, risking misdiagnosis.