Medicines and Healthcare Products Regulatory Agency

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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

See also: COVID-19 pandemic in the United Kingdom

On vaccines

On 2 December 2020, the MHRA became the first global medicines regulator to approve an RNA vaccine when it gave conditional and temporary authorization to supply for use of the Pfizer–BioNTech COVID-19 vaccine codenamed BNT162b2[10][11][12] (later branded as Comirnaty).[13][14] This approval enabled the start of the UK's COVID-19 vaccination programme. The regulator's public assessment report for the vaccine was published in 15 December.[15]

The MHRA went on to give conditional and temporary authorization to supply of further vaccines: AZD1222 from Oxford University and AstraZeneca on 30 December,[16] mRNA-1273 from Moderna on 8 January 2021,[17] and a single-dose vaccine from Janssen on 28 May 2021.[18] The approval of the Pfizer-BioNTech vaccine was extended to young people aged 12–15 in June 2021,[19] 5–11 in December 2021,[20] and from six months in December 2022.[21]

The status of the Oxford / AstraZeneca vaccine was upgraded to conditional marketing authorisation on 24 June 2021.[16] The MHRA confirmed in September 2021 that supplementary "booster" doses of these vaccines would be safe and effective, but stated that the Joint Committee on Vaccination and Immunisation had the task of advising if and when they should be used in this way.[22] Later that month, the MHRA said the Moderna vaccine could also be given as a booster dose.[23]

In August and September 2022, the MHRA approved the first bivalent COVID-19 booster vaccines.[24][25]

On tests

In January 2021, the MHRA expressed concern to the UK government over plans to deploy lateral flow tests in schools in England, stating that they had not authorised daily use of the tests due to concerns that negative results may give false reassurance.[26] The government suspended the scheme the following week, citing risks arising from high prevalence of the virus and higher rates of transmission of a new variant.[27]

Cough syrup containing codeine

In July 2023, MHRA began a consultation to reclassify cough syrups containing codeine (an opiate) as prescription-only medicines, in response to a rise in recreational drug abuse cases since 2018. There were 277 serious and fatal reactions to medicines containing codeine in 2021, and 243 in 2022.[28]

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". GOV.UK. 2 December 2020. Retrieved 2 December 2020.
  11. ^ Boseley, Sarah; Halliday, Josh (2 December 2020). "UK approves Pfizer/BioNTech Covid vaccine for rollout next week". The Guardian. Retrieved 2 December 2020.
  12. ^ "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine". GOV.UK. MHRA. 15 December 2020. Retrieved 16 December 2020.
  13. ^ "Comirnaty EPAR". European Medicines Agency (EMA). Retrieved 16 January 2021.
  14. ^ "Comirnaty Trade mark number UK00003531641". Intellectual Property Office. 9 September 2020. Retrieved 16 January 2021.
  15. ^ "Public Assessment Report for Pfizer/BioNTech COVID-19 vaccine" (PDF). MHRA. 11 December 2020. Retrieved 16 December 2020.
  16. ^ a b "Regulatory approval of COVID-19 Vaccine AstraZeneca". GOV.UK. MHRA. 25 June 2021. Retrieved 26 June 2021.
  17. ^ "Regulatory approval of COVID-19 Vaccine Moderna". GOV.UK. 8 January 2021. Retrieved 9 January 2021.
  18. ^ "Regulatory approval of COVID-19 Vaccine Janssen". GOV.UK. 28 May 2021. Retrieved 28 June 2021.
  19. ^ "The MHRA concludes positive safety profile for Pfizer/BioNTech vaccine in 12- to 15-year-olds". GOV.UK. 4 June 2021. Retrieved 2 October 2021.
  20. ^ "UK regulator approves use of Pfizer/BioNTech vaccine in 5 to 11-year olds". GOV.UK. MHRA. 22 December 2021. Retrieved 7 December 2022.
  21. ^ "Pfizer/BioNTech COVID-19 vaccine authorised for use in infants and children aged 6 months to 4 years". GOV.UK. MHRA. 6 December 2022. Retrieved 7 December 2022.
  22. ^ "MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines". GOV.UK. 9 September 2021. Retrieved 10 September 2021.
  23. ^ "MHRA statement on COVID-19 booster vaccines". GOV.UK. 14 September 2021. Retrieved 15 September 2021.
  24. ^ "First bivalent COVID-19 booster vaccine approved by UK medicines regulator". GOV.UK. MHRA. 15 August 2022. Retrieved 16 August 2022.
  25. ^ "Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator". GOV.UK. MHRA. 3 September 2022. Retrieved 7 December 2022.
  26. ^ Halliday, Josh (14 January 2021). "Regulator refuses to approve mass daily Covid testing at English schools". The Guardian. ISSN 0261-3077. Retrieved 15 January 2021.
  27. ^ Grafton-Green, Patrick (20 January 2021). "Daily Covid testing in schools paused amid emergence of new variant". LBC. Retrieved 21 January 2021.
  28. ^ "Some cough syrups could be made prescription-only over addiction fears". Sky News. 18 July 2023. Retrieved 18 July 2023.

Notes

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