規制動向

The MHRA has issued an updated Drug Safety Information (DSI) replacing DSI/2023/005, addressing defects in Belzer solutions used for organ preservation.

MHRA warns that several medical devices on the UK market do not meet UK MDR 2002 or EU requirements and must be removed from use and quarantined.

The MHRA released a list of Field Safety Notices covering the period 3 to 7 August 2026.

ResMed issued a Field Safety Notice for Astral 100 and 150 ventilators and related PCB spare parts made before Oct 2024, citing a fault that could unexpectedly interrupt ventilation.

The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices issued between 13 and 17 July 2026.

The UK MHRA warns that rectal catheters marketed as gas and colic relievers must not be used in infants for colic, gas discomfort or constipation. Users should stop and dispose of devices.

Zentiva UK Pharma Limited is recalling a batch of 0.5 mg Fingolimod capsules due to possible metal particle contamination.

The FDA reports a labeling mixup where Famotidine 20 mg tablets may be mislabeled as Carvedilol Phosphate ER capsules, along with other products.

The FDA has initiated a recall after an inspection revealed GMP violations that could compromise product sterility.

The FDA has issued a recall for a product because sterility could not be assured.

Orbit Pharma Limited is recalling a batch of Cyclizine Lactate 50 mg/ml injection solution due to GMP deficiencies at the manufacturing site.

The UK Medicines and Healthcare products Regulatory Agency released a series of Field Safety Notices covering multiple products between 8 and 12 June 2026.