Research and analysis

Use of UK plasma for the manufacture of five further plasma derived medicinal products and vCJD risk

The Medicines and Healthcare products Regulatory Agency (MHRA) published a review of the safety of albumins manufactured from UK-sourced plasma with respect to variant Creutzfeldt-Jakob disease (vCJD) risk in August 2023. A further review of the safety of five additional plasma derived medicinal products (Fibrinogen, Prothrombin Complex Concentrates (PCCs), C1 Esterase Inhibitor, Factor X and Protein C) manufactured from UK-sourced plasma with respect to vCJD risk has now been completed, with the results published in July 2026.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 9 July 2026

Documents

vCJD Risk Assessment for the use of UK plasma for the manufacture of 5 high priority plasma derived medicinal products (PDMPs): Fibrinogen, Prothrombin Complex Concentrates (PCCs), C1 Esterase Inhibitor, Factor X and Protein C

PDF, 1.63 MB, 31 pages

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Details

The vCJD safety of using UK-sourced plasma for the manufacture of five additional plasma derived medicinal products (Fibrinogen, Prothrombin Complex Concentrates (PCCs), C1 Esterase Inhibitor, Factor X and Protein C) was reviewed.Based on current epidemiology, manufacturing process capability, expert advice and information collected during previous reviews, it was concluded that UK-sourced plasma can be used for the manufacture of these five additional plasma derived medicinal products, in addition to the previously approved manufacture of immunoglobulins and albumins.

Published 9 July 2026