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Dear colleague,
This email updates you on details of recently published guidance on the coronavirus (COVID-19) pandemic aimed at supporting healthcare partners contributing to the essential global action needed to protect public health at this challenging time.
We welcome your feedback on what other information you would find useful – please email engagement@mhra.gov.uk.
Warning on temperature screening products for COVID-19 detection
We issued a warning that thermal cameras and other such temperature screening products, some of which make direct claims to screen for COVID-19, are not a reliable way to detect if people have the virus.
See our website for more information.
Publication of an interim clinical commissioning policy: Remdesivir for patients hospitalised with COVID-19 (adults and children of 12 years and older)
Following confirmation of a Conditional Marketing Authorisation (CMA) by the European Medicines Agency (EMA) for the use of remdesivir in the treatment of COVID-19, the scientific opinion given for remdesivir via the Early Access to Medicines Scheme (EAMS) put in place on 26th May 2020 has now lapsed.
From 3 July 2020, an interim clinical commissioning policy has been put in place to define routine access to remdesivir in the treatment of COVID-19 across the UK. The policy reflects the conditions of the CMA, but also includes secondary criteria to be used should there be limitations in the supply of remdesivir in the UK.
Further information can be found on Central Alerting System website.
Yellow Card reporting during the COVID-19 response
We are continuing to request 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. The Yellow Card scheme continues to operate as normal and we want to encourage reporting as there has been a decline in reporting during the pandemic.
We also request that reports for any suspected adverse drug reactions or side effects from medicines and adverse incidents involving medical equipment relating to COVID-19 treatment be reported on the tailored COVID-19 Yellow Card reporting site.
We have updated and added new terms related to COVID-19, allowing us to better capture clinical detail across the Yellow Card reporting methods. The COVID-19 Yellow Card reporting site forms part of our ongoing work to protect the public through enhanced COVID-19 vigilance and in preparation for large-scale use of potential new or repurposed medicines, medical devices, diagnostic tests and future vaccines. The site is not for reporting symptoms of COVID-19.
Anyone can now report an adverse incident with a medical device through the Yellow Card app. Relevant fields from the new medical device industry reporting standard have been chosen and presented in the Yellow Card app as user friendly questions to complete. This helps the reporter and also improves the quality of the reports sent to the manufacturer for their investigations into the cause.
In addition, for the first time, users can add barcode numbers of devices and healthcare providers can select the device problem type from a drop down based on international standardised terminology. We hope that being able to report on a mobile will encourage the quick reporting of adverse incidents involving medical devices.
We also have a new form in the Yellow Card app to collect information on suspected side effects caused by medicines used to treat COVID-19. This new form within the Yellow Card app includes customised questions to collect specific information in relation to COVID-19, including whether you have tested positive for the virus.
Clinical Practice Research Datalink (CPRD) data during COVID-19
CPRD, an MHRA centre, is making COVID-19 research a top priority by fast-tracking protocols. 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.
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 or phone us.
For more information please visit 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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