MHRA update on COVID-19

Dear colleague,

This email updates you on details of recently published MHRA guidance on the coronavirus (COVID-19) pandemic aimed at supporting healthcare partners.

How tests and testing kits for COVID-19 work

The guidance has information on the different types of tests and testing kits for COVID-19, and the specifications for manufacturers.

We have added a Target Product Profile for Laboratory-Based SARS-CoV-2 Viral Detection Tests.

Medical devices given exceptional use authorisations during the COVID-19 pandemic

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

The National Institute for Biological Standards and Control (NIBSC) selected by the Coalition for Epidemic Preparedness Innovations (CEPI) to test COVID-19 vaccines globally

We are delighted to announce that NIBSC will play a key role in evaluating vaccines that have been developed for COVID-19.

NIBSC is one of seven partner laboratories that have been selected by CEPI to form a centralised laboratory to standardise the measurement of immune responses generated by multiple COVID-19 vaccine candidates.

Please see the NIBSC website for more information.

Guidance for industry

We continue to update our guidance page for industry on GOV.UK as our response to COVID-19 evolves.

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 or phone us.

For more information please visit mhra.gov.uk.

We welcome your feedback on what other information you would find useful – please email engagement@mhra.gov.uk.

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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