The Generative Brain

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

The MHRA is the UK regulator for medicines, medical devices and blood components for transfusion, and an executive agency of the Department of Health and Social Care. For prion disease it matters in three ways. It ran the reviews that reversed the 1999 vCJD precaution against making medicines from UK donor plasma, first for immunoglobulins (CHM advice October 2020), then albumin (2023) and five further products (July 2026). It is the parent body of NIBSC, which hosts the CJD Resource Centre, the UK bank of reference material for prion tests. And as licensing authority it applies TSE safety requirements to medicines and would regulate any UK trial of a prion therapy. Its advisory body on medicines is the Commission on Human Medicines. Information only, not medical, legal or regulatory advice.

Key facts

  • The MHRA regulates medicines, medical devices and blood components for transfusion in the UK; its board does not take regulatory decisions, which sit with the chief executive and executive committee.
  • The Commission on Human Medicines, formed in October 2005 under what is now regulation 10 of the Human Medicines Regulations 2012, advises ministers and the licensing authority on safety, efficacy and quality of medicines, working through scientific advisory committees. The MHRA describes it as an independent advisory body.
  • A March 2020 MHRA review first looked at lifting the 1999 UK plasma ban for COVID-19 convalescent hyperimmune immunoglobulin; CHM deferred, then on 8 October 2020 considered full evidence and judged the added vCJD risk from UK plasma for immunoglobulins negligible.
  • The immunoglobulin assessment adapted a DHSC and UCL CORU blood component model to 17 normal and 6 hyperimmune products, using manufacturer prion reduction factors of 4.8 to 10.5 log10 for normal and 7.3 to 9.4 for hyperimmune products; leucodepletion cut modelled infection risk about fivefold.
  • The worst case modelled over 33 years, 30,000 heavy users of the leucodepleted product with the lowest prion reduction factor, gave up to 24 clinical vCJD cases; the report set this beside a March 2019 SaBTO worst case of 15 cases from fresh frozen plasma over 50 years.
  • Conditions for using UK plasma are leucodepletion, deferral of higher risk donors, donor to recipient traceability, and a licence variation with a product-specific risk assessment for each medicine, reviewed by the MHRA with CHM advice.
  • The 2020 to 2021 review drew on the MRC Prion Unit, the National CJD Research and Surveillance Unit, the ACDP TSE Subgroup, SaBTO, DHSC and Public Health England.
  • The government announced on 25 February 2021 that UK plasma could be used for immunoglobulins after the MHRA review and CHM advice.
  • On CHM advice the MHRA confirmed in June 2023 that albumin may also be made from UK plasma, and its August 2023 paper found no or minimal added vCJD risk, citing manufacturer prion reduction factors of 5.7 to 12.7 log.
  • On 9 July 2026 the MHRA approved UK donor plasma for fibrinogen, prothrombin complex concentrates, C1 esterase inhibitor, Factor X and Protein C, after independent experts judged the vCJD risk negligible; the press release headline was amended on 15 July 2026 after NHSBT said it was misleading.
  • NIBSC became a centre of the MHRA on 1 April 2013, and in April 2025 WHO redesignated the MHRA Science and Research group, formerly NIBSC, as a collaborating centre for biological standards.
  • The CJD Resource Centre research tissue bank is registered with the Health Research Authority at NIBSC and MHRA, South Mimms.
  • MHRA accepts EDQM certificates of suitability, including those for animal or human origin materials that have had a TSE risk evaluation, which must be included in Modules 1 and 3 of an application.
  • A search excerpt, not opened, says MHRA licence guidance requires compliance with the EU note for guidance on minimising animal spongiform encephalopathy risk (EMEA/410/01), and that unlicensed medicines fall under SI 2003/1680 on TSE safety.
  • Sangamo reported a productive interaction with the MHRA about a prion disease study, with a clinical trial application expected as early as mid-2026 (company statement).

Timeline

  1. 1999UK ban on using UK donor plasma for plasma-derived medicines as a vCJD precaution.
  2. 2005Commission on Human Medicines formed.
  3. 2013NIBSC moves into the MHRA.
  4. 2020Initial MHRA review on UK plasma for hyperimmune immunoglobulin; CHM defers.
  5. 2020CHM concludes on 8 October that UK plasma for immunoglobulins adds negligible vCJD risk.
  6. 2021Government lifts the ban for immunoglobulins on 25 February.
  7. 2021MHRA publishes the critical risk assessment report on 21 April.
  8. 2023MHRA confirms albumin may be made from UK plasma.
  9. 2023MHRA albumin vCJD risk paper published on 15 August.
  10. 2025First NHS patients receive medicines made from UK plasma.
  11. 2025WHO redesignates the MHRA Science and Research group, formerly NIBSC.
  12. 2026MHRA approves UK plasma for five further products on 9 July.
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