03 July 2023

A ban on producing plasma-derived medical products containing albumin has been lifted in the UK.

Such products and their derivatives were banned to limit the spread of Creutzfeldt Jakob Disease (CJD).

Now, the Medicines and Healthcare products Regulatory Agency (MHRA) are confirming that the ban is lifted, following advice from the Department of Health and Social Care-sponsored independent Commission on Human Medicines.

The news that albumin can now be safely derived from UK plasma donors was announced by Dr Alison Cave, Chief Safety Officer at the MHRA.

She said: “We are committed to ensuring that all patients have access to safe, effective medical products and I am delighted that our work in this area continues to bear fruit.

“I am so pleased that we have been able to support the lifting of this ban by examining the safety evidence and that there is now the potential to produce life-saving treatments from plasma that has been donated in the UK.”

These albumin products are given to thousands of critically ill patients each year after blood loss from injuries or severe burns, as well as certain medical conditions.

The MHRA point out that robust safety standards and risk mitigation measures must be followed and medical products made from UK-derived plasma “will be evaluated to the same criteria as those made from non-UK plasma”.

David Webb, NHS England Chief Pharmaceutical Officer for England, said: “The use of locally sourced plasma treatments will help save more lives and the NHS will continue to work with partners to secure a supply chain of medicines that patients rely on.”

Source: MHRA


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