ABPI response to MHRA clinical trials framework
The Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with the Health Research Authority (HRA), has announced a new regulatory framework for clinical trials in the UK.
New measures include a legislative requirement to publicly register clinical trials and share summary results with research participants, as well as new guidance to help researchers involve people with lived experience in clinical trials and recruit a diverse cohort of participants.
Richard Torbett, ABPI Chief Executive, said: “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centred on patient safety and the benefits of participating in research. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.
“We welcome the MHRA and HRA’s commitment to work with our industry to co-develop new regulatory guidance and their pragmatic approach to patient & public involvement and trial diversity. We look forward to working with them to make the UK an attractive destination for clinical trials.”.