MHRA Approves UK-Donor Plasma for Five Additional Plasma-Derived Medicines

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK-donor plasma for five plasma-derived medicinal products: fibrinogen, prothrombin complex concentrates, C1 esterase inhibitor, factor X and protein C.

The decision follows an extensive safety review that assessed the potential risk of variant Creutzfeldt-Jakob disease (vCJD) transmission. Independent experts concluded that the risk of vCJD transmission through these products is negligible.

The approval marks another milestone in the UK's effort to rebuild its domestic supply of plasma-derived medicines following a 1999 precautionary ban on the use of UK-sourced plasma to manufacture plasma-derived medicinal products. The MHRA lifted restrictions for immunoglobulin and human albumin products in 2021 and 2023, respectively.