MHRA guidance on coronavirus (COVID-19) (2023)

ADR report updated to include data up to and including 15 June 2022.

Added new page - 'Access Consortium: Alignment with ICMRA consensus on immunobridging for authorising new COVID-19 vaccines' under Vaccines and vaccines safety.

Linked to the new Temporary advice for management of oral retinoid medicines during the COVID-19 pandemic guidance, in the 'Medicines and COVID-19' section

Added "The MHRA concludes positive safety profile for Pfizer/BioNTech vaccine in 12- to 15-year-olds" to the 'vaccines and vaccine safety' collection

Published links to decision documents and press release on the approval of the COVID-19 Vaccine Janssen.

Added link to news story on Pfizer/BioNTech COVID-19 vaccine shelf-life being extended from 5 to 31 days to 'Vaccines and vaccine safety' section.

Added link to MHRA response to JCVI advice on COVID-19 Vaccine AstraZeneca for people aged under 40.

Added "MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots" to the Vaccines and vaccine safety collection

Added 'UK regulator confirms that people should continue to receive the COVID-19 Vaccine AstraZeneca' to the vaccines and vaccines safety section

Added "MHRA response to Irish authorities’ action to temporarily suspend the AstraZeneca COVID-19 Vaccine" to the section on vaccines & vaccine safety

Added a link to the MHRA response to Danish authorities’ action to temporarily suspend the AstraZeneca COVID-19 Vaccine

Added a link to 'ACCESS Consortium guidance on strain changes in authorised COVID-19 vaccines', in the 'Vaccines and vaccine safety' section.

Added links to the COVID-19 vaccine safety surveillance strategy report, the vaccine adverse reactions report and the press release covering the publication of these, in the 'Vaccines and vaccine safety' section.

Added 'Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator' and 'Regulatory approval of COVID-19 Vaccine Moderna' to the Vaccines and vaccine safety collection

Added 'Oxford University/AstraZeneca Covid-19 vaccine approved' to vaccines and vaccine safety

Added link to decision on Regulatory approval of COVID-19 Vaccine AstraZeneca, in the 'Vaccines and vaccine safety' category.

Added a link to news statement on Independent batch release testing of COVID-19 (coronavirus) vaccines by the NIBSC.

Added link to page on Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 in the 'Vaccines and vaccine safety' section.

Added link to news story on approval of first UK COVID-19 vaccine, in the 'Vaccines and vaccine safety' section

Added 'Oxford/AstraZeneca COVID-19 vaccine: MHRA statement confirming letter received’ to the 'Vaccines and vaccine safety' collection

Added link to guidance on 'Advice for developers of COVID-19 vaccines', in the 'Vaccines and vaccine safety' section.

Added 'Pfizer/BioNTech COVID-19 vaccine: MHRA statement confirming data received'

Created a new 'Vaccines and vaccine safety' document collection section for existing and future documents regarding COVID-19 vaccines and vaccine candidates

Added 'Pfizer / BioNTech COVID-19 vaccine: MHRA statement' to News Stories

Added link to 'Guidance on minimising disruptions to the conduct and integrity of clinical trials' in the 'Clinical trials' section.

Added 'NIBSC selected by CEPI to test coronavirus vaccines globally' to the News Stories collection

Added guidance on Warfarin

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.

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

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

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

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

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.

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

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

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.

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

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

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

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

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.

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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'.

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

First published.