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MHRA guidance on coronavirus (COVID-19)

We are producing guidance for industry 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), part of the MHRA, also plays a major role in assuring the quality of biological medicines, worldwide.

The British Pharmacopoeia has published a statement on its products and services during the outbreak, including some actions for any British Pharmacopoeia Chemical Reference Substance (BPCRS) customers who are ordering any substances classified as controlled drugs or precursor chemicals.

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 manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak
  2. Information for hospital blood banks during the coronavirus (COVID-19) outbreak
  3. Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak
  4. Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak
  5. Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)
  6. New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19)
  7. Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak

Medical devices

Medicines and COVID-19

News stories

Published 19 March 2020
Last updated 7 April 2020 + show all updates
  1. 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

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

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

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

  5. 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

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

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

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

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

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

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

  12. 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.

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

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

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

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

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

  18. 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'.

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

  20. First published.