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Dear Colleague,
This email updates you on details of recently published MHRA guidance on the coronavirus (COVID-19) pandemic aimed at supporting healthcare partners.
MHRA issues exceptional use authorisation for NHS Test and Trace COVID-19 Self-Test device
We have issued an authorisation to the Department of Health and Social Care (DHSC) to allow the use of the NHS Test and Trace COVID-19 Self-Test kit to detect infection in asymptomatic individuals.
This is an antigen lateral flow test which can give a result in 30 minutes.
Please see more information on our website.
CPRD data during COVID-19
Clinical Practice Research Datalink (CPRD) is making COVID-19 research a top priority, by fast-tracking protocols for COVID-19 research. All approved study protocol summaries are published within 72 hours, to ensure transparency and to help avoid unnecessary duplication. Please check the list of studies for regular updates.
CPRD data can be linked to other datasets to support COVID-19 research, including Second Generation Surveillance System (SGSS) COVID-19 positive virology test data.
CPRD has a COVID-19 synthetic dataset replicating patients presenting to primary care with symptoms indicative of COVID-19 that includes data on sociodemographic and clinical risk factors.
The latest COVID-19 feasibility counts in CPRD data are also available on the CPRD website.
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.
Indemnity arrangements for the COVID-19 vaccination programme
DHSC, NHS Resolution, and NHS England and NHS Improvement issued a joint letter regarding Indemnity arrangements for the COVID-19 vaccination programme.
Please see the Central Alerting System website for more information.
Therapeutic Anticoagulation (Heparin) in the management of severe COVID-19 (SARS-CoV-2 Positive) Patients
The Chief Medical Officer issued an alert to confirm that the therapeutic dose of either unfractionated heparin or subcutaneous low molecular weight heparin should not be offered in the treatment of patients with COVID-19, unless there is a standard indication for therapeutic anti-coagulation, such as the acute management of acute deep vein thromboses or pulmonary emboli, or as part of a clinical trial.
Please see the Central Alerting System website for actions for clinicians, NHS Trusts, health boards and hospitals.
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 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 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
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Read our guidance on coronavirus (COVID-19)
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