Medicines and Healthcare products Regulatory Agency

Last updated

Medicines and Healthcare products Regulatory Agency
UK Medicines & Healthcare Products Regulatory Agency logo.svg
Executive agency overview
Formed1 April 2003;20 years ago (2003-04-01)
Preceding agencies
  • Medicines Control Agency
  • Medical Devices Agency
Headquarters10 South Colonnade, London E14
United Kingdom
Minister responsible
Executive agency executives
  • June Raine, Chief Executive
  • Stephen Lightfoot, Chair
  • Jon Fundrey, Chief Operating Officer
Parent department Department of Health and Social Care
Child agencies
Website www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency OOjs UI icon edit-ltr-progressive.svg

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

Contents

The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. [1]

Structure

The MHRA is divided into three main centres:[ citation needed ]

The MHRA has several independent advisory committees which provide the UK Government with information and guidance on the regulation of medicines and medical devices. There are currently eight such committees:[ citation needed ]

History

In 1999, the Medicines Control Agency (MCA) took over control of the General Practice Research Database (GPRD) from the Office for National Statistics. The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for the parent organisation and one of the centres within the group. At the same time, CPRD was made a separate centre of the MHRA. [2]

Roles

  1. Operate post-marketing surveillance – in particular the Yellow Card Scheme – for reporting, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
  2. Assess and authorise of medicinal products for sale and supply in the UK.
  3. Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
  4. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
  5. Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
  6. Regulate clinical trials of medicines and medical devices.
  7. Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
  8. Promote safe use of medicines and devices.
  9. Manage the Clinical Practice Research Datalink and the British Pharmacopoeia.

The MHRA hosts and supports a number of expert advisory bodies, including the British Pharmacopoeia Commission, and the Commission on Human Medicine which replaced the Committee on the Safety of Medicines in 2005.[ citation needed ]

The MHRA manages the Early Access to Medicines Scheme (EAMS), which was created in 2014 to allow access to medicines prior to market authorisation where there is a clear unmet medical need.

European Union

Prior to the UK's departure from the European Union in January 2021, the MHRA was part of the European system of approval. Under this system, national bodies can be the rapporteur or co-rapporteur for any given pharmaceutical application, taking on the bulk of the verification work on behalf of all members, while the documents are still sent to other members as and where requested.

From January 2021, the MHRA is instead a stand-alone body, [3] although under the Northern Ireland Protocol the authorisation of medicines marketed in Northern Ireland continued to be the responsibility of the European Medicines Agency. [4] However, as a result of the 2023 Windsor Framework, the MHRA is expected to once again deal with authorisation throughout the United Kingdom. [5]

Funding

The MHRA is funded by the Department of Health and Social Care for the regulation of medical devices, whilst the costs of medicines regulation is met through fees from the pharmaceutical industry. [6] This has led to suggestions by some MPs that the MHRA is too reliant on industry, and so not fully independent. [7]

In 2017, the MHRA was awarded over £980,000 by the Bill & Melinda Gates Foundation to fund its work with the foundation and the World Health Organization on improving safety monitoring for new medicines in low and middle-income countries. [8] In response to a Freedom of Information request, in 2022 the MHRA stated that approximately £3 million had been received from the Gates Foundation for a number of initiatives spanning several financial years. [9]

Key people

June Raine has been the chief executive of the MHRA since 2019, [10] succeeding Ian Hudson who had held the post since 2013. [11]

The MHRA's strategy is set by a board which consists of a chairperson (appointed for a three-year term [12] by the Secretary of State for the Department of Health and Social Care) [13] and eight non-executive directors, together with the chief executive and chief operating officer. [14] The chair since September 2020 is Stephen Lightfoot, who is also chair of Sussex Community NHS Foundation Trust and non-executive chair of Sussex Primary Care Limited. [13] Sir Michael Rawlins was the chair from 2014 to 2020. [15]

Notable interventions

Covid-19

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 [16] [17] [18] (later branded as Comirnaty). [19] [20] 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. [21]

The MHRA went on to give conditional and temporary authorization to supply of further vaccines: AZD1222 from Oxford University and AstraZeneca on 30 December, [22] mRNA-1273 from Moderna on 8 January 2021, [23] and a single-dose vaccine from Janssen on 28 May 2021. [24] The approval of the Pfizer-BioNTech vaccine was extended to young people aged 12–15 in June 2021, [25] 5–11 in December 2021, [26] and from six months in December 2022. [27]

The status of the Oxford / AstraZeneca vaccine was upgraded to conditional marketing authorisation on 24 June 2021. [22] 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. [28] Later that month, the MHRA said the Moderna vaccine could also be given as a booster dose. [29]

In August and September 2022, the MHRA approved the first bivalent COVID-19 booster vaccines. [30] [31]

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. [32] 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. [33]

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. [34]

Criticism

In 2005, the MHRA was criticised by the House of Commons Health Committee for, among other things, lacking transparency, [35] and for inadequately checking drug licensing data. [36]

The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma , [37] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [38] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.

The Cumberlege Report, also known as the Independent Medicines and Medical Devices Safety Review, is a comprehensive report commissioned by the UK government to investigate the harm caused by certain medical treatments and devices. Released in 2020, the report highlighted the suffering of thousands of patients who experienced complications from treatments such as pelvic mesh implants, sodium valproate, and Primodos. It criticized MHRA's failure to adequately respond to these issues, calling for improved patient safety measures, better regulation of medical devices, and increased support for those affected. [39]

The COVID Response & Recovery APPG wrote to Stephen Brine, chairperson of the Health Select Committee, in October 2023 raising concerns about serious failures by MHRA and demanding an urgent investigation. [40]

See also

Related Research Articles

<span class="mw-page-title-main">European Medicines Agency</span> Agency of the European Union

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods.

The Joint Committee on Vaccination and Immunisation (JCVI) is an independent expert advisory committee that advises United Kingdom health departments on immunisation, making recommendations concerning vaccination schedules and vaccine safety. It has a statutory role in England and Wales, and health departments in Scotland and Northern Ireland may choose to accept its advice.

<span class="mw-page-title-main">COVID-19 vaccine</span> Vaccine against SARS-CoV-2

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID‑19).

<span class="mw-page-title-main">Moderna COVID-19 vaccine</span> RNA COVID-19 vaccine

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<span class="mw-page-title-main">BioNTech</span> German biotechnology company

BioNTech SE is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develops pharmaceutical candidates based on messenger ribonucleic acid (mRNA) for use as individualized cancer immunotherapies, as vaccines against infectious diseases and as protein replacement therapies for rare diseases, and also engineered cell therapy, novel antibodies and small molecule immunomodulators as treatment options for cancer.

<span class="mw-page-title-main">Pfizer–BioNTech COVID-19 vaccine</span> Type of vaccine for humans

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<span class="mw-page-title-main">June Raine</span> Chief executive of the MHRA

Dame June Munro Raine, is a British doctor who is currently serving as the Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Raine spent much of her career in the Medicines Division of the MHRA.

<span class="mw-page-title-main">V451 vaccine</span> Terminated COVID-19 vaccine candidate

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<span class="mw-page-title-main">Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020</span> Amendment Regulations for Human Medicines (Coronavirus and Influenza) in England

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<span class="mw-page-title-main">COVID-19 vaccination in the United Kingdom</span> Immunisation against COVID-19

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<span class="mw-page-title-main">ALC-0315</span> Chemical compound

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<span class="mw-page-title-main">Valneva COVID-19 vaccine</span> Vaccine candidate against COVID-19

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<span class="mw-page-title-main">National Health Regulatory Authority (Bahrain)</span>

The National Health Regulatory Authority (NHRA) is an independent regulatory body established in 2010, under Law No. 38 of 2009, of the Kingdom of Bahrain.

<span class="mw-page-title-main">History of COVID-19 vaccine development</span> Scientific work to develop a vaccine for COVID-19

SARS-CoV-2, the virus that causes COVID-19, was isolated in late 2019. Its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten the development of a preventive COVID-19 vaccine. Since 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.

<span class="mw-page-title-main">European Commission–AstraZeneca COVID-19 vaccine dispute</span> Dispute between the European Union and AstraZeneca

A dispute broke out in January 2021 between the European Commission and the pharmaceutical company AstraZeneca AB about the provision of COVID-19 vaccines during the COVID-19 pandemic, and, in February, spilled out into a dispute over Article 16 of the Northern Ireland Protocol. Vaccination proceeded apace in the UK but more slowly in the EU, and by the end of March 2021, over 30% of the UK population had received at least one dose of vaccine compared to about 8% of the EU population. This was partly due to limited availability of the AstraZeneca vaccine in the EU. The World Health Organization and the European Medicines Agency continued to state that the vaccine was safe and effective. However, a representative of the European Medicines Agency said in June that vaccines based on the mRNA technology should be preferred if available for all age groups, including for the over 60s.

<span class="mw-page-title-main">COVID-19 vaccination in the Republic of Ireland</span> Immunisation plan against COVID-19

The COVID-19 vaccination programme in the Republic of Ireland is an ongoing mass immunisation campaign that began on 29 December 2020 in response to the COVID-19 pandemic in the Republic of Ireland. Ireland's vaccination rollout has been praised as one of the most successful rollouts in the world and was ranked number one in the European Union in terms of its percentage of adult population fully vaccinated, and was also ranked number one in the EU for the number of booster vaccines administered.

<span class="mw-page-title-main">Embolic and thrombotic events after COVID-19 vaccination</span> Post vaccination adverse effects

Post-vaccination embolic and thrombotic events, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), vaccine-induced prothrombotic immune thrombocytopenia (VIPIT), thrombosis with thrombocytopenia syndrome (TTS), vaccine-induced immune thrombocytopenia and thrombosis (VITT), or vaccine-associated thrombotic thrombocytopenia (VATT), are rare types of blood clotting syndromes that were initially observed in a number of people who had previously received the Oxford–AstraZeneca COVID‑19 vaccine (AZD1222) during the COVID‑19 pandemic. It was subsequently also described in the Janssen COVID‑19 vaccine, leading to the suspension of its use until its safety had been reassessed. On 5 May 2022 the FDA posted a bulletin limiting the use of the Janssen Vaccine to very specific cases due to further reassessment of the risks of TTS, although the FDA also stated in the same bulletin that the benefits of the vaccine outweigh the risks.

<span class="mw-page-title-main">COVID-19 vaccination in Singapore</span> Plan to immunize against COVID-19

The COVID-19 vaccination in Singapore is an ongoing immunisation campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country. Singapore has a very high vaccination rate, with more than 92% of its total population having completed their vaccination regimen.

References

  1. ↑ "About us". gov.uk. Medicines and Healthcare products Regulatory Agency. Retrieved 20 November 2020.
  2. ↑ "Medicines and Healthcare products Regulatory Agency Expands". MHRA. 28 March 2013. Archived from the original on 11 April 2013. Retrieved 4 April 2013.
  3. ↑ "MHRA post-transition period information". GOV.UK. 1 September 2020. Retrieved 2 December 2020.
  4. ↑ "SPCs and the Northern Ireland Protocol". GOV.UK. Intellectual Property Office. 1 June 2021. Retrieved 26 June 2021.
  5. ↑ "Research Briefing: Northern Ireland Protocol: The Windsor Framework" (PDF). House of Commons Library. Parliament of the United Kingdom. 21 March 2023. Retrieved 2 June 2023.
  6. ↑ "How is the MHRA funded?". MHRA. Archived from the original on 4 June 2014. Retrieved 18 September 2013.
  7. ↑ Flynn MP, Paul. "Early Day Motion 1197: MHRA". Session 2012-13. House of Commons. Retrieved 18 September 2013.
  8. ↑ "MHRA awarded over £980,000 for collaboration with the Bill and Melinda Gates Foundation and the World Health Organisation". GOV.UK. MHRA. 15 December 2017. Retrieved 25 June 2022.
  9. ↑ "Freedom of Information on funding from the Bill and Melinda Gates Foundation (FOI 22/035)". GOV.UK. MHRA. 31 May 2022. Retrieved 25 June 2022.
  10. ↑ "June Raine". GOV.UK. Retrieved 2 December 2020.
  11. ↑ "Dr Ian Hudson". GOV.UK. Retrieved 2 December 2020.
  12. ↑ Dunton, Jim (25 June 2020). "Department issues final call for candidates to be next MHRA chair". Civil Service World. Retrieved 2 December 2020.
  13. 1 2 "Stephen Lightfoot". GOV.UK. Retrieved 2 December 2020.
  14. ↑ "Our governance". GOV.UK. Medicines & Healthcare products Regulatory Agency. Retrieved 2 December 2020.
  15. ↑ "Medicines & Healthcare products Regulatory Agency – Chair". GOV.UK. Cabinet Office. 7 August 2017. Retrieved 15 December 2020.
  16. ↑ "UK medicines regulator gives approval for first UK COVID-19 vaccine". GOV.UK. 2 December 2020. Retrieved 2 December 2020.
  17. ↑ Boseley, Sarah; Halliday, Josh (2 December 2020). "UK approves Pfizer/BioNTech Covid vaccine for rollout next week". The Guardian. Retrieved 2 December 2020.
  18. ↑ "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine". GOV.UK. MHRA. 15 December 2020. Retrieved 16 December 2020.
  19. ↑ "Comirnaty EPAR". European Medicines Agency (EMA). Retrieved 16 January 2021.
  20. ↑ "Comirnaty Trade mark number UK00003531641". Intellectual Property Office. 9 September 2020. Retrieved 16 January 2021.
  21. ↑ "Public Assessment Report for Pfizer/BioNTech COVID-19 vaccine" (PDF). MHRA. 11 December 2020. Retrieved 16 December 2020.
  22. 1 2 "Regulatory approval of COVID-19 Vaccine AstraZeneca". GOV.UK. MHRA. 25 June 2021. Retrieved 26 June 2021.
  23. ↑ "Regulatory approval of COVID-19 Vaccine Moderna". GOV.UK. 8 January 2021. Retrieved 9 January 2021.
  24. ↑ "Regulatory approval of COVID-19 Vaccine Janssen". GOV.UK. 28 May 2021. Retrieved 28 June 2021.
  25. ↑ "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.
  26. ↑ "UK regulator approves use of Pfizer/BioNTech vaccine in 5 to 11-year olds". GOV.UK. MHRA. 22 December 2021. Retrieved 7 December 2022.
  27. ↑ "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.
  28. ↑ "MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines". GOV.UK. 9 September 2021. Retrieved 10 September 2021.
  29. ↑ "MHRA statement on COVID-19 booster vaccines". GOV.UK. 14 September 2021. Retrieved 15 September 2021.
  30. ↑ "First bivalent COVID-19 booster vaccine approved by UK medicines regulator". GOV.UK. MHRA. 15 August 2022. Retrieved 16 August 2022.
  31. ↑ "Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator". GOV.UK. MHRA. 3 September 2022. Retrieved 7 December 2022.
  32. ↑ 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.
  33. ↑ Grafton-Green, Patrick (20 January 2021). "Daily Covid testing in schools paused amid emergence of new variant". LBC. Retrieved 21 January 2021.
  34. ↑ "Some cough syrups could be made prescription-only over addiction fears". Sky News. 18 July 2023. Retrieved 18 July 2023.
  35. ↑ "The Influence of the Pharmaceutical Industry, Fourth Report of Session 2004–05, Volume I" (PDF). Page 5: "Greater transparency is also fundamental to the medicines regulatory system. There has to be better public access to materials considered by the MHRA prior to licensing". House of Commons Health Committee. Retrieved 16 August 2013.
  36. ↑ "The Influence of the Pharmaceutical Industry, Fourth Report of Session 2004–05, Volume I" (PDF). Page 4: "the Medicines and Healthcare Products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. ". House of Commons Health Committee. Retrieved 16 August 2013.
  37. ↑ Goldacre, Ben (2012). Bad pharma : how drug companies mislead doctors and harm patients. London: Fourth Estate. ISBN   978-0-00-735074-2.
  38. ↑ Health Committee: Evidence. House of Commons Health Committee. 2004. p. 98. ISBN   9780215024572.
  39. ↑ Haskell, Helen (6 August 2020). "Cumberlege review exposes stubborn and dangerous flaws in healthcare". BMJ. 370: m3099. doi:10.1136/bmj.m3099. ISSN   1756-1833. PMID   32763955.
  40. ↑ "UK Medicines Regulator a "Serious Risk" to Patient Safety". Medscape UK. Retrieved 6 March 2024.
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