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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.
Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with COVID-19
We have updated the guidance which includes advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic to reflect changes to regulations following Brexit transition.
Specification for Rapidly Manufactured CPAP System to be used during the COVID-19 outbreak
The guidance is a specification of the minimally clinically acceptable Continuous Positive Airway Pressure (CPAP) system to be used in UK hospitals. We have uploaded a new PDF to reflect changes to regulations following Brexit transition.
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.
COVID-19 Therapeutic Alert: Interleukin-6 inhibitors (tocilizumab and sarilumab) for critically ill patients with COVID-19 pneumonia (adults)
The Chief Medical Officer (CMO) issued an alert to recommend that NHS trusts/health boards consider prescribing either tocilizumab or sarilumab to hospitalised patients with COVID-19 pneumonia being treated with non-invasive ventilation (including high-flow nasal oxygen therapy or continuous positive airway pressure ventilation) or invasive mechanical ventilation.
Please see the Central Alerting System website for more information.
Propofol emulsion for infusion and injection (all strengths) supply disruption
The Department of Health & Social Care and NHS England and Improvement issued an alert to confirm that due to the significant increase in demand for propofol to support the UK’s COVID-19 response, there are limited supplies of high volume propofol presentations listed below in the supply chain:
- Propofol 1% 100ml vials
- Propofol 1% 50ml vials and
- Propofol 2% 50ml vials
Further deliveries are expected over the coming weeks, however intermittent supply issues across this range of propofol presentations and concentrations are likely to occur for several weeks.
The alert contains advice on the management of affected patients.
Please see the Central Alerting System 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 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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