The Generative Brain

Commission on Human Medicines (CHM), United Kingdom

The Commission on Human Medicines is the statutory UK expert committee that advises health ministers and the licensing authority (the MHRA) on the safety, quality and efficacy of medicines. It was set up in October 2005, replacing the Medicines Commission and the Committee on Safety of Medicines, and its functions now sit in regulation 10 of the Human Medicines Regulations 2012. For prion disease its role is in plasma medicines. Its predecessor, the Committee on Safety of Medicines, gave ministers position statements on nvCJD and plasma derived medicines in 1998, the period in which the UK stopped using UK donor plasma for fractionation. CHM then gave the advice that reopened that route: on 8 October 2020 it judged the added vCJD risk from UK plasma for immunoglobulins negligible, and in 2022 it reviewed albumin, which the MHRA cleared in June 2023 on its advice. This entry is information only and is not medical or regulatory advice.

Key facts

  • CHM is an advisory non-departmental public body sponsored by the Department of Health and Social Care and supported by the MHRA through an Expert Committee Support team.
  • The Medicines (Advisory Bodies) Regulations 2005 abolished the Medicines Commission and the Committee on Safety of Medicines and created CHM in their place, with power to appoint Expert Advisory Groups and delegate work to them; GOV.UK gives its start as October 2005.
  • Under regulation 10 of the Human Medicines Regulations 2012 it must advise on the safety, quality and efficacy of medicines and promote collection of adverse reaction data, may advise ministers on request or on its own initiative, and must advise the licensing authority where the law requires consultation or the authority asks.
  • Its chair and commissioners are ministerial public appointments, members may not hold personal interests in the pharmaceutical industry, and summary minutes of CHM and Expert Advisory Group meetings from 2014 onward are published with confidential material removed.
  • Ten Expert Advisory Groups support it, among them a Biologicals and Vaccines group covering biological products, an Oncology and Haematology group and an Infection group.
  • In March 2020 an initial MHRA review on using UK plasma for COVID-19 convalescent hyperimmune immunoglobulin went to CHM, which deferred full consideration until trial data were available.
  • On 8 October 2020 CHM considered the MHRA's full evidence review and concluded that making immunoglobulins from UK plasma would add negligible vCJD risk, provided leucodepletion, deferral of higher risk donors and donor to recipient traceability apply.
  • Under that advice each manufacturer must seek a licence variation, and the MHRA must review each product with a product-specific risk assessment, taking advice from the CHM Clinical Trials, Biologicals and Vaccines Expert Advisory Group and from CHM itself.
  • The UK government announced on 25 February 2021 that UK plasma could be used for immunoglobulins, citing the MHRA review and CHM advice.
  • For albumin, CHM and its biologicals expert group were first asked whether a review was needed; in June 2022 CHM agreed to a review without new modelling and asked for manufacturer prion reduction factors, expert opinion from the National CJD Research and Surveillance Unit, and clinical need data, which were put to it in October 2022.
  • On 26 June 2023 the MHRA confirmed, on CHM advice, that albumin may be made from UK plasma under the same safeguards used for immunoglobulins.
  • The MHRA announcement of 9 July 2026 extending UK plasma use to five further products does not name CHM; it refers only to independent experts.

Timeline

  1. 1998Committee on Safety of Medicines, a CHM predecessor, issues a position statement to UK health ministers on nvCJD and plasma derived medicines.
  2. 1998Further Committee on Safety of Medicines position statement to ministers on the same subject.
  3. 2005CHM established, replacing the Medicines Commission and the Committee on Safety of Medicines.
  4. 2020CHM defers full consideration of UK plasma for hyperimmune immunoglobulin.
  5. 2020CHM concludes on 8 October that UK plasma for immunoglobulins adds negligible vCJD risk.
  6. 2021Government lifts the immunoglobulin ban, citing CHM advice.
  7. 2022CHM agrees that a review of albumin from UK plasma should go ahead.
  8. 2022Collated albumin evidence presented to CHM.
  9. 2023MHRA confirms on CHM advice that albumin may be made from UK plasma.
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