A collaboration between the European Commission (EC), European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has led to the publication of key principles regarding the use of electronic product information (ePI) in the European Union (EU). Read more “Key principles of electronic product information for human medicines in the EU”
Category: Product information
The latest updates on a variety of pharmaceutical products
Regulators issue warnings for use of malaria drugs for COVID-19
Chloroquine and hydroxychloroquine have been touted as potential treatments for COVID-19 patients, however clinical data is still very limited and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Read more “Regulators issue warnings for use of malaria drugs for COVID-19”
Expanding the availability of critical ventilator devices to fight COVID-19
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”
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”
Highlights from the February CHMP meeting 2020
From their meeting in February, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the February CHMP meeting 2020”
The purple book
The US Food and Drug Administration (FDA) has launched its first searchable database of biological product information, called the Purple Book. Read more “The purple book”
Did you know that Bluetooth-related flaws are threatening hundreds of smart medical devices?
Smart medical devices, including medical tools, implants and pacemakers are being exposed to cyber-attack, due to vulnerabilities in their Bluetooth Low Energy (BLE) protocol. Read more “Did you know that Bluetooth-related flaws are threatening hundreds of smart medical devices?”
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”
A harmonised approach to electronic product information (ePI)
In 2017, the European Commission (EC) identified electronic product information (ePI) as a means of improving how EU citizens access information about medicines. They have now released a set of principles to harmonise this approach. Read more “A harmonised approach to electronic product information (ePI)”
Highlights from the December CHMP meeting 2019
From their meeting in December, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the December CHMP meeting 2019”