The European Commission (EC) has asked EU law makers to delay the implementation of the incoming Medical Device Regulation (MDR), which is due to apply from 26 May 2020. Read more “European Commission adopts one year delay to MDR”
Category: Regulation
Regulatory news and updates
Regulis offers COVID-19 regulatory support to Public Sector
With global regulators adapting guidelines in response to the pandemic, Regulis has offered assistance with ventilator development and registration, and development and registration of other devices and medicines relevant to the fight against COVID-19. Read more “Regulis offers COVID-19 regulatory support to Public Sector”
EMA publish Regulatory Science Strategy to 2025
The strategy outlines the European Medicines Agency’s (EMA) plan for advancing regulatory science over the next five years. Read more “EMA publish Regulatory Science Strategy to 2025”
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”
MDCG rolls out host of new guidances and updates with MDR looming
With 26th May fast approaching, the Medical Device Co-ordination Group (MDCG) has published three new guidances, two updated guidances and an implementation/preparedness plan for the incoming Medical Device Regulation (MDR). Read more “MDCG rolls out host of new guidances and updates with MDR looming”
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”
Revised medical device risk management standards and European regulatory requirements
Understanding the current expectations of a medical device risk management system is a critical element of meeting the new regulatory requirements. Read more “Revised medical device risk management standards and European regulatory requirements”
MHRA demonstrate flexibility in national application procedure with quick vaccine approval
A high dose Trivalent Influenza Vaccine was granted a UK licence within seven months, compared to the standard twelve month review time for national approvals. Read more “MHRA demonstrate flexibility in national application procedure with quick vaccine approval”
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”
10 recommendations to unlock the potential of big data in medicines regulation
The European Medicines Agency (EMA) and Head of Medicines Agency (HMA) have released a joint report with recommendations to unlock the potential of data in medicines regulation and improve public health. Read more “10 recommendations to unlock the potential of big data in medicines regulation”