MHRA

News

MHRA's AI as medical device pilot opens for applicants

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regul

News

UK first country in Europe to clear Leqembi, but NICE says n...

The UK drugs regulator has approved Eisai and Biogen's Alzheimer's disease therapy Leqembi, shortly after an EU committee turned it down on the grounds that its modest efficacy did not outw

Digital

AI is coming and regulators are getting prepared

The UK’s MHRA recently published its guidance on its approach to both regulating the use of AI for drug and medical devices, and how it can utilise the technology to improve its regulating

R&D

Case Study: MHRA

Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.

News

MHRA ‘sandbox’ to pilot AI regulation will go live soon

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said it will launch a pilot programme in the coming weeks to see how it can evolve the regulation o

Patients