MHRA update on COVID-19

Dear colleague,

This email updates you on details of recently published guidance for industry on the coronavirus (COVID-19) pandemic and, where relevant, how we are working closely with our healthcare partners.

Please share this email with your members.

Assuring confidence in COVID-19 antibody testing

Antibody testing has played a vital part in the fight against the COVID-19 pandemic. To support laboratories conducting COVID-19 antibody testing, the National Institute for Biological Standards and Control (NIBSC) Infectious Disease Diagnostics division developed a CE-marked SARS-CoV-2 antibody Quality Control (QC) run control (20/B764) to help laboratories monitor the consistency and performance of their assay.

The QC contains IgG antibodies to Spike and Nucleoprotein and has been validated on most of the main immunoassay platforms and manual ELISA kits on the market.

Please see the NIBSC website for the full portfolio of COVID-19 related products and research reagents.

Guidance and regulatory flexibilities

Please see our regulatory flexibilities page for industry guidance on flexible approaches to regulation which we are taking during the COVID-19 pandemic.

New or updated guidance published on our general guidance page for industry since the last edition of this email:

Updated guidance:
Managing clinical trials during COVID-19

Details of update:
We included a section on management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials.
Updated guidance:
How tests and testing kits for COVID-19 work

Details of update:
The document for industry and manufacturers has been updated to include the new UK Conformity Assessed (UKCA), CE and CE UKNI (Northern Ireland) markings.
Updated guidance:
Medical devices given exceptional use authorisations during the COVID-19 pandemic

Details of update:
We updated the list of medical devices given exceptional use authorisations and the list of devices no longer covered.

Subscribing to updates on GOV.UK

You can sign up for email updates about the MHRA’s work – you will then receive an email every time the MHRA publishes a new page or makes a significant edit to an existing page.

Contacting the MHRA

Most of our workforce is working from home, although NIBSC is continuing essential laboratory activities on site. If you need to get in touch with the MHRA during this period, please email info@mhra.gov.uk or phone 0203 080 6000.

For more information please visit mhra.gov.uk.

We welcome your feedback on what other information you would find useful – please email.

Kind regards,

Patient, Public and Stakeholder Engagement team
Communications division

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 0203 080 6000
Email: engagement@mhra.gov.uk
gov.uk/mhra

Read our guidance on coronavirus (COVID-19)

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