Canadian Medical and Biological Engineering Society

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Not to be confused with the Modern Humanities Research Association, also abbreviated MHRA.
Medicines and Healthcare products Regulatory Agency
Executive agency overview
Formed1 April 2003; 22 years ago (2003-04-01)
Preceding agencies
  • Medicines Control Agency
  • Medical Devices Agency
Headquarters10 South Colonnade, London E14
United Kingdom
Executive agency executives
  • Lawrence Tallon, Chief Executive
  • Anthony Harnden, Chair
Parent departmentDepartment of Health and Social Care
Websitewww.gov.uk/mhra Edit this at Wikidata

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.[1]

The MHRA is an executive agency, sponsored by the Department of Health and Social Care, and has offices in London, Hertfordshire and Leeds.[2]

The agency plays a central role in protecting public health by regulating products used in healthcare across the UK.

It also provides scientific advice to the life sciences sector and contributes to the development of regulatory policy and standards at national and international levels.[1]

Laurence Tallon assumed the role of chief executive in 2025, succeeding Dame June Raine who had held the post since 2019.[3]

The agency is governed by a unitary board of directors and a chairperson.[1] The current Chair of the MHRA is Professor Anthony Harnden.[4]

Responsibilities

The MHRA’s responsibilities are to[1]:

  • ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness)
  • secure safe supply chain for medicines, medical devices and blood components
  • promote international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
  • educate the UK public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
  • enable innovation and research and development that is beneficial to public health
  • collaborate with partners in the UK and internationally to support its mission to enable the earliest access to safe medicines and medical devices and to protect public health.

Governance

The MHRA operates as an executive agency of the Department of Health and Social Care. It is led by a Chief Executive, who is accountable to the Secretary of State for Health and Social Care.[5]

The agency’s governance structure includes a Board responsible for strategic oversight and assurance.[6]

A number of committees and expert groups provide independent scientific and clinical advice on regulatory decisions.[7]

History

The MHRA was established in 2003 through the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The creation of a single regulator was intended to streamline oversight of medicines and medical devices and strengthen the UK’s ability to respond to emerging safety issues.

Following the United Kingdom’s withdrawal from the European Union, the MHRA assumed additional responsibilities that had previously been carried out through EU regulatory frameworks, including the independent licensing of medicines for the UK market.[8]

Funding

The MHRA is funded through a combination of grant-in-aid from the UK government and income generated from fees and charges levied on the pharmaceutical, medical device, and life sciences industries for regulatory services. These services include marketing authorisation applications, inspections, licensing, and scientific advice.[5]

The level of government funding and fee income is set annually as part of the UK government’s spending review and budgetary process. The MHRA publishes details of its financial performance, including income, expenditure, and fee structures, in its annual report and accounts.[9]

Notable interventions

COVID-19 Vaccine Authorisation

In December 2020, the MHRA became the first medicines regulator in the world to grant temporary authorisation for the Pfizer–BioNTech COVID-19 vaccine (BNT162b2), following a rolling review of clinical trial data on safety, quality, and efficacy. The decision enabled the rapid deployment of the vaccine across the United Kingdom and was widely cited as a major milestone in the global response to the COVID-19 pandemic.[10]

Approval of Casgevy (Exagamglogene Autotemcel)

In 2023, the MHRA became the first regulatory authority globally to approve Casgevy (exagamglogene autotemcel), a CRISPR-based gene-editing therapy for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia. The approval was recognised internationally as a significant regulatory and scientific milestone in the clinical application of genome-editing technologies.[11]

Rare Disease therapies

The MHRA has outlined proposals to reform the regulatory framework for rare disease treatments, aiming to reduce barriers to development and approval while maintaining high safety standards. The initiative focuses on improving evidence generation for small patient populations, strengthening post-market surveillance, and working with a Rare Disease Consortium of patients, academics, and industry to develop more flexible pathways for innovative and personalised therapies. The announcement was hailed by patient groups as a vital step forward.[12]

Artificial Intelligence Commission

The MHRA has launched a bold new National Commission on the Regulation of AI in Healthcare, which will be responsible for advising the MHRA on a world-leading framework for the regulation of AI products, to help make Great Britain the fastest and safest place to regulate AI and software in the world. The Commission includes representation from clinicians, other regulators, and global AI experts.[13]

Decentralised Manufacturing

The UK was the first country in the world to introduce a tailored framework for the regulation of innovative products manufactured at or close to the location where a patient receives care. This means that medicines with a very short shelf life and highly personalised medicines can more easily be made in or near a hospital setting and can get to the patients who need them safely and much more quickly.[14]


References

  1. ^ a b c d "About Us". MHRA.
  2. ^ "MHRA launches new digital hub in Leeds to drive innovation and regional growth". GOV.UK - MHRA.
  3. ^ "New Chief Executive appointed at MHRA". GOV.UK - MHRA.
  4. ^ "New Chair of the MHRA". GOV.UK - MHRA.
  5. ^ a b "Framework agreement between DHSC and the Medicines and Healthcare products Regulatory Agency". GOV.UK - DHSC.
  6. ^ "Our governance". GOV.UK - MHRA.
  7. ^ "CHM membership". GOV.UK - MHRA.
  8. ^ "UK withdrawal from the EU on 31 January 2020". EMA.
  9. ^ "MHRA Annual Report and Accounts 2024 to 2025". GOV.UK - MHRA.
  10. ^ "UK medicines regulator gives approval for first UK COVID-19 vaccine".
  11. ^ "MHRA authorises world-first gene therapy that aims to cure sickle-cell disease and transfusion-dependent β-thalassemia".
  12. ^ "Major change for rare disease treatments on way, signals MHRA".
  13. ^ "New Commission to help accelerate NHS use of AI".
  14. ^ "Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly". GOV.UK - MHRA.

Notes

This article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.

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