The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year. This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding to the COVID-19 outbreak. According
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MHRA announces a risk-based prioritisation of on-site Good Practice inspections during COVID-19
By Marie Doyle-Rossi on
Posted in Food & Drug Regulatory
On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19. The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as office-based assessments and information-exchange with…
TechForce19: UK Government promises up to £25,000 for innovator companies that develop digital support solutions for COVID-19
By Sarah Cowlishaw on
Posted in Uncategorized
On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19. The DHSC is making £500,000 available, with funding of up to £25,000 per company. The challenge, named TechForce19, aims to increase community support for the elderly, vulnerable…
EMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic
By Grant Castle, Robin Blaney & Marie Doyle-Rossi on
Posted in Food & Drug Regulatory, Medicinal Products
On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance). The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).
The Guidance provides information on changes and protocol deviations that…
MHRA issues specification for a “Rapidly Manufactured Ventilator System” for use in hospitals during the COVID-19 outbreak
By Sarah Cowlishaw on
Posted in Food & Drug Regulatory, Medical Devices
The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a specification for a “Rapidly Manufactured Ventilator System” (“RMVS”), setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the “RMVS Specification”). The purpose of the RMVS Specification is to meet the UK healthcare system’s increased demand…
DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19
By Brian Kelly, Katharina Ewert & Hannah Berry on
On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers.
The Department of Education and Cabinet Office has published guidance on key workers for COVID-19. The guidance…