MHRA update on COVID-19

Dear colleague,

Please share this email with your members.

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.

First UK COVID-19 vaccine given approval

On 2 December, we approved the first COVID-19 vaccine for the UK developed by Pfizer/BioNTech.

The decision that the vaccine has met the MHRA’s strict standards of safety, quality and effectiveness was made with advice from the Commission on Human Medicines, the government’s independent expert scientific advisory body. It follows a rigorous, scientific and detailed review of all the available data by the MHRA. This was done using a regulatory process known as a ‘rolling review’, which can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible.

Please see the Decision page on our website for more information about the COVID-19 vaccine.

Guidance and regulatory flexibilities

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

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

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 National Institute for Biological Standards and Control (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)

If you would like to share this with a friend or colleague, hit the Forward button or send them this link to view the email in a browser.

Unsubscribe or change your email address at any time on your subscriber preferences page.

If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.

All other enquiries can be directed to email.support@mhra.gov.uk.

This is an automatically generated email. Please do not reply directly to this notification.
This service is provided to you at no charge by the Medicines and Healthcare products Regulatory Agency.