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Update on MHRA response during COVID-19

Written by, and published on behalf of, MHRA


Dear colleague

We wanted to update you on how we are working to support healthcare professionals, industry and patients as part of the essential global action needed to protect public health at this challenging time. Please share this information with relevant teams in your organisation and your networks/contacts.

We are working quickly to respond to the operational challenges posed by the Coronavirus (COVID-19) pandemic and will continue to update our guidance page for industry on GOV.UK as our response to COVID-19 evolves.

We are prioritising work to support and authorise the development of vaccines, clinical trials of new medicines, and helping to manage the supply of medicines and other healthcare products. We also continue to provide information to patients, manufacturers and healthcare professionals through our established information channels and alert systems.

Helping to develop vaccines
We are drawing on the expertise we gained through our work on previous virus outbreaks such as Zika, Ebola and Middle East respiratory syndrome (MERS).

One of our centres, the National Institute for Biological Standards and Control (NIBSC), is working closely with the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI) to ensure the availability of the biological materials needed to support a quick and reliable diagnosis of infection, evaluation of vaccines and the effectiveness of treatments.

Ensuring quick and efficient authorisation of clinical trials
We have procedures for rapid scientific advice, reviews and approvals and are ready to support manufacturers, researchers and other regulators. We will prioritise and provide any assistance for clinical trials applications submitted for COVID-19. We will ensure that all applications are dealt with swiftly and we can guide all applicants step-by-step through the application process. 

Specification for ventilators to be used in UK hospitals during the outbreak and COVID-19 test kits
We have developed guidance that sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.

We have also set out how manufacturers can submit COVID-19 test kits for regulatory approval.

COVID-19 and high blood pressure medication

There is no evidence from clinical or epidemiological studies that treatment with angiotensin converting enzyme inhibitors (ACE inhibitors or ACE-i) or angiotensin receptor blockers might worsen COVID-19 infection. Please see our news story for more information.

Yellow Card reporting during the COVID-19 response
We are now requesting that all reports to our Yellow Card Scheme (the system for reporting suspected side effects of medicines or possible problems with a medical device) be submitted electronically instead of on paper. Our website also explains what to do if someone has reported a suspected side effect using a paper Yellow Card after 17 March.

CPRD support for COVID-19 research

Clinical Practice Research Datalink (CPRD) recognises the need for enabling essential COVID-19 research that could impact public health policy and have put in place measures to facilitate this. Whilst it does mean that some of its services will need to be scaled back slightly to make this happen, it is expediting processing of protocols relating to COVID-19 research.

The Central Alerting System (CAS)

We run the Central Alerting System on behalf of the healthcare family and issue MHRA-authored safety messages alongside messaging from the Department of Health and Social Care (including the Chief Medical Officer), NHS England and NHS Improvement and Public Health England.

In the current COVID-19 situation we are accepting registrations from anyone working in the health and social care sector, regardless of whether we already have any registrations from their organisation (the business-as-usual model is based on organisational cascade of safety messages). This is a temporary measure while we respond to this situation. We will notify anyone who registers via the two links below when we intend to stop sending alerts via these routes.

Register for alerts about COVID-19

Register for all alerts that we issue including those about COVID-19

Contacting the MHRA

Most of our workforce is now 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.

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.

This is a rapidly changing situation and we will keep our approach under review. We are working with a wide range of organisations across the health sector and as well as playing our part in the global response, our priority is to help support the NHS to care for people during this difficult time.

For more information please visit www.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
Stay connected: mhra.gov.uk/stayconnected

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11 Aug 2020
10:12 am