MHRA safety review gives UK plasma donations go ahead

MHRA safety review gives UK plasma donations go ahead
Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK‑donor plasma for five high‑priority plasma-derived medicinal products.
Following an extensive safety review, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK‑donor plasma for five high‑priority medicines, helping to strengthen supplies of life-saving treatments used by thousands of critically ill patients each year.
The decision, announced today (9 July 2026), follows an assessment of the potential risk of variant Creutzfeldt‑Jakob disease (vCJD). Independent experts concluded that the risk of transmission through these products is negligible.
Plasma proteins from donated human blood can be used to make medicines known as plasma-derived medicinal products (PDMPs). They are typically given to critically ill patients to replace or restore vital plasma proteins and help treat or prevent serious diseases, bleeding, infections, and other conditions where the body’s natural plasma components are missing, deficient, or not functioning properly in the body. This includes patients with conditions such as bleeding disorders, neurological and autoimmune diseases, liver disease or sepsis.
A precautionary ban on the use of UK-sourced plasma for manufacturing these medicines has been in place since 1999, requiring reliance on imported plasma at a time of growing global demand. Restrictions have been lifted for immunoglobulin and human albumin products in 2021 and 2023 respectively. This latest decision extends the use of UK plasma for these essential treatments.
The review drew on advanced modelling to assess the risk of patients receiving the proposed five PDMPs being infected with vCJD.
Allowing the use of plasma from UK blood donors for the manufacture of Fibrinogen, Prothrombin Complex Concentrates (PCCs), C1 Esterase Inhibitor, Factor X and Protein C, will aid supply and reduce reliance on imports from other countries.
The public are encouraged to donate blood and plasma regularly, given the growing demand for PDMPs and potential supply constraints. Plasma can currently be donated directly at three specialist centres in Twickenham, Reading and Birmingham. However it is also taken from every whole blood donation collected across the country.
Dr Alison Cave, MHRA Chief Safety Officer, said:
“Patient safety is our top priority and we will always take precautionary measures where there is any possibility of risk to public health. Having thoroughly reviewed the evidence, we are now confident that the risk of using plasma from UK donors is negligible, ensuring these potentially life-saving products will become available to those who need them.”
Gerry Gogarty, Director of Blood and Plasma supply at NHS Blood and Transplant, says:
“This announcement is another significant step which highlights the trust and confidence in UK plasma and our ability to create a more resilient UK supply of plasma medicines.
“These life-changing treatments are only possible thanks to our incredible blood and plasma donors. As the UK’s ambition to increase plasma medicines production grows, we need more regular donors to ensure these vital treatments are available to every patient who depends on them.
“We urge people to come forward and help us continue to grow and boost our supplies.”
To register or book an appointment to donate blood or plasma, visit the NHSBT website or download the NHS Give Blood app.
Notes to editors
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.