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MHRA guidance on coronavirus (COVID-19)

We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.

The MHRA is working closely with DHSC and other healthcare partners on COVID-19.

We are prioritising work including:

  • supporting and authorising the development of vaccines
  • clinical trials of new medicines
  • managing the supply of medicines and healthcare products

We also provide information to patients, manufacturers and healthcare professionals through our established information channels and alert systems.

The National Institute for Biological Standards and Control (NIBSC), a centre of the Medicines and Healthcare products Regulatory Agency, also plays a major role in assuring the quality of biological medicines worldwide.

The NIBSC has developed a portfolio of reference and research reagents to support areas of diagnostics, vaccine development and research on COVID-19, and has called upon the scientific community to build standardisation into the pandemic response.

Clinical Practice Research Datalink (CPRD), another agency centre, is making COVID-19 research a top priority by fast-tracking protocols for COVID-19 research. All approved study protocol summaries are published within 72 hours to ensure transparency and to help avoid unnecessary duplication.

The British Pharmacopoeia (BP) has published a statement on its products and services during the outbreak, including some actions for any BP Chemical Reference Substance (BPCRS) customers who are ordering any substances classified as controlled drugs or precursor chemicals. BP has also published a statement on offering free access to supportive pharmacopoeial texts to users at no cost.

The MHRA Inspectorate blog has several posts covering the approach taken on clinical trials and advice on other areas like remote working.

Our guidance on coronavirus (COVID-19)

Regulatory flexibilities

Clinical trials

Inspections and good practice

  1. Guidance for industry on MHRA’s expectations for return to UK on-site inspections
  2. Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak
  3. Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
  4. Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak
  5. Information for hospital blood banks during the coronavirus (COVID-19) outbreak
  6. Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak
  7. Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak
  8. Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)
  9. Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak

Medical devices

  1. Don’t rely on temperature screening products for detection of coronavirus (COVID-19), says MHRA
  2. Medical devices given exceptional use authorisations during the COVID-19 pandemic
  3. Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19)
  4. 3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic
  5. How tests and testing kits for coronavirus (COVID-19) work
  6. Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
  7. Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak
  8. Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
  9. Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
  10. Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak

Medicines and COVID-19

Fake or unlicensed medicines

News stories

  1. New synthetic datasets to assist COVID-19 and cardiovascular research
  2. Coronavirus: new website for reporting medicines side effects and equipment incidents
  3. New reagent available to support global diagnostic testing of coronavirus (COVID-19)
  4. MHRA approves new life-saving breathing aid to help keep coronavirus (COVID-19) patients out of intensive care
  5. MHRA services during the Coronavirus (COVID-19) response
  6. Coronavirus: global crackdown sees a rise in unlicenced medical products related to COVID-19
  7. MHRA update on novel coronavirus (COVID-19)
  8. MHRA issues a scientific opinion for the first medicine to treat COVID-19 in the UK

Health and safety general advice

Guidance from government for different workplaces

Published 19 March 2020
Last updated 11 August 2020 + show all updates
  1. Added a link to new guidance for industry on MHRA’s expectations for return to UK on-site inspections, in the 'Inspections and good practice' section.

  2. Added link to 'New synthetic datasets to assist COVID-19 and cardiovascular research' in the 'News stories' section.

  3. Linked to news story on not relying on temperature screening products for detection of coronavirus (COVID-19), in the 'Medical Devices' section.

  4. Added link to page on 'Medical devices given exceptional use authorisations during the COVID-19 pandemic', in the 'Medical devices' section.

  5. Added link to news story on suspending recruitment to COVID-19 hydroxychloroquine trials, in the 'Medicines and COVID-19' section.

  6. Added link to the Medical Device Alert (MDA) on results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable.

  7. Added a link to new guidance on the regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19), in the 'Medical Devices' section

  8. Added link to new guidance on 3D printing to the 'Medical Devices' section

  9. Added link to news story on MHRA supporting the use of remdesivir as the first medicine to treat COVID-19 in the UK, in the 'News stories' section.

  10. Added Early access to medicines scheme (EAMS) scientific opinion on Remdesivir in the treatment of patients hospitalised with suspected or laboratory-confirmed COVID-19 to the 'Medicines and COVID-19' section

  11. Added information about the work of Clinical Practice Research Datalink (CPRD) in relation to COVID-19.

  12. Added link to new guidance on immunomodulatory drugs and temporary pregnancy prevention guidance during COVID-19, in the Medicines and COVID-19 section

  13. Added a link to NIBSC announcement on antibody research reagent which is now available for COVID-19.

  14. Linked to new guidance on how tests and testing kits for coronavirus (COVID-19) work in the 'Medical Devices' section. This replaces previous guidance on COVID-19 tests. It includes an explanation of how the different testing kits work, the specification industry need to follow and how to apply for exemptions.

  15. Added a new section linking to general government guidance for different workplaces.

  16. Added link to press release on Senior Enforcement Advisor at UK Medicines Regulator warns against purchasing fake or unlicensed coronavirus (COVID-19) medicines

  17. Added a link to new guidance on 'Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus' in the 'Medicines and COVID-19' section.

  18. Added link to news story on 'New reagent available to support global diagnostic testing of coronavirus (COVID-19)'

  19. Added link to news story on MHRA approval of COVID-19 vaccine trial in 7 working days, in the 'Clinical Trials' section.

  20. Added link to Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak in the 'Inspections and good practice' section.

  21. Added link to statement: Commission on Human Medicines advice on ibuprofen and coronavirus (COVID-19) in the 'Medicines and COVID-19' section

  22. Added a section on Medical Device Alerts (MDAs) related to coronavirus (COVID-19)

  23. Added link to new guidance on Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak, in the 'Inspections and good practice' section.

  24. Added link to Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak in the Inspections and Good Practice section

  25. Added link to news story on MHRA investigating 14 cases of fake or unlicensed COVID-19 medical products

  26. Added link to new information for hospital blood banks during the coronavirus (COVID-19) outbreak, in the Inspections and good practice section.

  27. Published new page on Guidance on coronavirus (COVID-19) tests and testing kits

  28. Added a link to new guidance on Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak, in the Inspections and good practice section

  29. Added link to new guidance on 'MHRA regulatory flexibilities resulting from coronavirus (COVID-19)'

  30. Added link to news story on approval of new life-saving breathing aid to help keep coronavirus (COVID-19) patients out of intensive care.

  31. Added a link to Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak, to the Medicines Regulation section.

  32. Added link to content on Status of Phase 1 clinical trials in response to coronavirus, in the 'Clinical trials' section.

  33. Published links to a statement on British Pharmacopoeia products and services during the COVID-19 outbreak, and new guidance on medical devices clinical investigations.

  34. Added a link in the Inspections section to new guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)

  35. Added a link in the Medical Devices section to new content on Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak.

  36. Added link to news story on Coronavirus (COVID-19) and high blood pressure medication

  37. Added a link to new guidance on Regulatory status of equipment being used to help prevent coronavirus (COVID-19)

  38. Added link to news story on Chloroquine and Hydroxychloroquine not being licensed for coronavirus (COVID-19) treatment

  39. Added a link to new guidance on exemptions from Devices regulations during the coronavirus (COVID-19) outbreak.

  40. Added new link to Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak

  41. Added links to new content: 'Ibuprofen use and Coronavirus (COVID19)', 'Specification for ventilators to be used in UK hospitals during the coronavirus outbreak' and 'Regulatory approval for Coronavirus (COVID-19) test kits'.

  42. Added link to news story on MHRA services during the Coronavirus (COVID-19) response

  43. First published.