Over the course of this blog series, we have deliberately created space for voices beyond the MHRA to challenge, reflect and help shape our thinking ... This series has brought together a rich set of perspectives from outside and within the MHRA.
). Over the course of this blog series, we have deliberately created space for voices beyond the MHRA to challenge, reflect and help shape our thinking ... This series has brought together a rich set of perspectives from outside and within the MHRA.
This was a collaborative project led by the MHRA in collaboration with National Institute for Health and CareExcellence (NICE) to clarify the regulation and evaluation of DMHTs that qualify as software as a medical device (SaMD).
MHRA guidance on clinical investigations clarify when clinical studies involving medical devices need to be reported to the MHRA as a clinical investigation ... event reporting obligations to the MHRA.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved catumaxomab (Korjuny) to treat malignant ascites in adults when standard treatment of their cancer is no longer feasible.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved catumaxomab (Korjuny) to treat malignant ascites in adults when standard treatment of their cancer is no longer feasible.
Alongside the response, the MHRA is opening the call for applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices, with testing themes directly informed by the Commission's recommendations.
Within days of announcing its MHRA registration for its AI-powered ... “Our recent MHRA registration for the Renalyx haemodialysis system opened an important door for us in the UK & Uk allied markets.
The MHRA has today joined international medicines regulators in a joint statement calling for alternatives to animal testing throughout the lifecycle of human medicines to be advanced and implemented, wherever and as soon as possible.
The MHRA has today joined international medicines regulators in a joint statement calling for alternatives to animal testing throughout the lifecycle of human medicines to be advanced and implemented, wherever and as soon as possible.
Press release - Zepzelca® (lurbinectedin) in combination with atezolizumab approved by the MHRA as first-line maintenance therapy for extensive-stage small cell lung cancer in the United Kingdom.