The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK-donor plasma for the manufacture of five additional Plasma-Derived Medicinal Products (PDMPs) following an extensive safety review that found the risk of transmitting variant Creutzfeldt-Jakob disease (vCJD) through these medicines to be negligible.

Announced on July 9, 2026, the decision marks another step in restoring the use of domestically sourced plasma for essential medicines after restrictions were introduced in 1999 as a precaution against vCJD transmission. Since then, the UK has relied largely on imported plasma to manufacture several plasma-derived therapies.

The latest approval covers the manufacture of Fibrinogen, Prothrombin Complex Concentrates (PCCs), C1 Esterase Inhibitor, Factor X and Protein C using plasma collected from UK blood donors. These therapies are used to treat patients with serious conditions, including bleeding disorders, neurological and autoimmune diseases, liver disease, sepsis and other disorders where essential plasma proteins are deficient or absent.

According to the MHRA, the decision was based on advanced risk modelling and an independent scientific assessment, which concluded that the likelihood of vCJD transmission through the approved products is extremely low.

The move is expected to strengthen the UK's supply of plasma-derived medicines by reducing dependence on imported plasma at a time of increasing global demand and growing pressure on international supply chains. Earlier regulatory changes had already permitted the use of UK plasma for manufacturing immunoglobulin products in 2021 and human albumin in 2023.

Dr Alison Cave, Chief Safety Officer at the MHRA, said patient safety remains the regulator's highest priority and noted that the comprehensive review provided sufficient evidence to support the safe use of UK-donor plasma for these additional medicines.

NHS Blood and Transplant welcomed the decision, describing it as an important milestone in building a more resilient domestic supply of plasma medicines. The organisation also encouraged people across the UK to donate blood and plasma regularly to help meet the increasing demand for plasma-derived therapies.

Plasma can currently be donated directly at specialist centres in Twickenham, Reading and Birmingham, while plasma is also recovered from every whole blood donation collected across the country.

The MHRA stated that the decision will help ensure a more secure supply of critical treatments for thousands of patients who rely on plasma-derived medicines each year while maintaining rigorous safety standards.