With an urgent need for the rapid manufacture of life-saving ventilator systems for hospitals to fight the current pandemic, the Medicines and Healthcare products Regulatory Agency (MHRA), along with their international counterparts, have outlined how they intend to expand the availability of such devices. Read more “Expanding the availability of critical ventilator devices to fight COVID-19”
Category: International
The first in-human trial for a coronavirus vaccine!
The first dose of a potential coronavirus vaccine has been administered to a clinical trial participant in the US. Read more “The first in-human trial for a coronavirus vaccine!”
COVID-19: Asia-Pacific Regulatory roundup
Catch up with the latest COVID-19 related regulatory interventions in the Asia-Pacific region. Read more “COVID-19: Asia-Pacific Regulatory roundup”
A potential plasma-derived therapy for COVID-19
Development has been initiated for an anti-SARS-CoV-2 polyclonal hyper-immune globulin (H-IG) to treat high-risk individuals with COVID-19. Read more “A potential plasma-derived therapy for COVID-19”
Coronavirus-induced drug and device shortages
As the novel coronavirus outbreak continues to spread across the globe, Europe and the US are bracing for disruption to the medicine supply chain. Read more “Coronavirus-induced drug and device shortages”
FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic
The Centres for Disease Control and Prevention’s (CDC) 2019-nCov Real-Time RT-PCR Diagnostic Panel has been approved for use across the US. Read more “FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic”
China green-lights new reagent test kit for the novel coronavirus
A batch of nucleic acid reagent test kits have been approved with a medical device registration certificate, to help tackle the deadly novel coronavirus (2019-nCoV) outbreak. Read more “China green-lights new reagent test kit for the novel coronavirus”
Key actions to be taken by the FDA to advance development of coronavirus medical countermeasures
The US Food and Drug Administration (FDA) has announced critical actions to expedite the development and availability of medical products needed for the diagnosis, treatment and prevention of the coronavirus and related future outbreaks. Read more “Key actions to be taken by the FDA to advance development of coronavirus medical countermeasures”
A reference list of the various drug and medical device regulators in Europe
For some countries the regulatory functions are performed by the ministry of health. As you will see, some regulatory agencies will not have a working website. Read more “A reference list of the various drug and medical device regulators in Europe”
WHO warns that lack of new antibiotic drug development is threatening the fight against drug-resistant bacteria
“The threat of antimicrobial resistance has never been more immediate and the need for solutions more urgent.” Read more “WHO warns that lack of new antibiotic drug development is threatening the fight against drug-resistant bacteria”