UK MHRA authorizes use of UK‑donor plasma for five plasma‑derived medicines fibrinogen, PCCs, C1 esterase inhibitor, Factor X, and Protein C after scientific review confirms negligible vCJD risk, strengthening domestic supply resilience.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
The UK Medicines and Healthcare products Regulatory Agency has approved the use of plasma collected from UK blood donors to manufacture five high-priority plasma-derived medicinal products (PDMPs), marking another major step toward restoring domestic plasma production. The regulatory decision follows an extensive scientific review concluding that the risk of transmitting variant Creutzfeldt-Jakob disease (vCJD) through these medicines is negligible.
The decision applies to fibrinogen, prothrombin complex concentrates (PCCs), C1 esterase inhibitor, Factor X, and Protein C, all of which are used to treat severe bleeding disorders, hereditary angioedema, coagulation deficiencies, sepsis, liver disease, neurological disorders, and other life-threatening conditions.
A precautionary ban on using UK-sourced plasma for manufacturing plasma-derived medicines has remained in place since 1999 following concerns about vCJD transmission during the bovine spongiform encephalopathy (BSE) outbreak. The MHRA previously lifted restrictions for immunoglobulin products in 2021 and human albumin in 2023. The latest decision extends UK plasma use to five additional essential therapies following updated evidence supporting their safety.
Scientific review supports negligible vCJD risk
The MHRA’s assessment combined epidemiological evidence, mathematical modelling, manufacturing data, and independent expert review. The analysis found that the current incidence of vCJD is substantially lower than historical projections, with no new UK clinical cases reported since 2016 and no confirmed transmission through plasma-derived medicinal products. The review also noted that more than 40 million UK blood components have been issued without documented plasma-related vCJD transmission.
Mathematical modelling evaluated both a realistic and highly conservative scenario for future vCJD cases. Even under conservative assumptions, the predicted transmission risk remained extremely low. The assessment also showed that manufacturing processes remove prions efficiently, with reported prion reduction factors ranging from 4.1 to 9.4 log10, comparable to those previously accepted for immunoglobulin and albumin products.
Independent experts from the UK National CJD Research & Surveillance Unit and the MRC Prion Unit and Institute of Prion Diseases concluded that earlier estimates had overestimated the potential risk and that available evidence supports the continued safe use of UK plasma for manufacturing these products.
Rising demand drives need for domestic plasma supplies
The review also highlighted growing demand for plasma-derived medicines across the UK. Hospital procurement data showed substantial increases in use over the past five years, including a 365% rise in C1 esterase inhibitor use and a 57% increase in PCC use, while global plasma supplies remain under pressure. Expanding domestic manufacturing is expected to improve supply resilience and reduce dependence on imported plasma.
MHRA and NHS encourage continued plasma donation
MHRA Chief Safety Officer Dr. Alison Cave said the agency’s review confirmed that patient safety remains the highest priority and that current evidence demonstrates the additional risk from UK-donor plasma is negligible, allowing wider access to these potentially life-saving medicines.
Gerry Gogarty, Director of Blood and Plasma Supply at NHS Blood and Transplant, said the decision strengthens confidence in UK plasma while supporting a more resilient national supply of plasma-derived medicines. He emphasized that increasing production will require continued support from regular blood and plasma donors.
Path Forward
The MHRA’s decision represents another milestone in rebuilding the UK’s domestic plasma medicine supply chain after more than two decades of restrictions. By allowing UK plasma to be used for five additional plasma-derived medicinal products, regulators expect to improve long-term availability of critical therapies while maintaining existing safeguards, including donor screening, leucodepletion, traceability, and rigorous manufacturing controls.
Reference
Risk Assesment for Use of UK Plasmas_Cotting_Factors_vCJD_Final_InternallyApproved_08July26
MHRA safety review gives UK plasma donations go ahead – GOV.UK
About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.
