London, 15 August 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has undertaken a further review of the safety of albumins manufactured from UK plasma with respect to vCJD.
The vCJD safety of using UK-sourced plasma for the manufacture of albumin medicinal products was considered. Based on current epidemiology, manufacturing process capability, expert advice and information collected for previous reviews, it was concluded that UK-sourced plasma can be used for the manufacture of albumin medicinal products, in addition to the already approved use for the manufacture of immunoglobulins.
Source – UK Government