UK To Launch Notification Scheme For Low-Risk Trials
The UK regulator’s new clinical trials notification scheme will allow researchers to proceed with low-risk studies without the need for further assessment.
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The Medicines and Healthcare products Regulatory Agency says it is in “everyone’s best interest” if clinical trial sponsors seeking UK approval for low-risk Phase III and IV studies make use of its new notification scheme that will cut the 30-day statutory evaluation timeline by more than half.
The UK medicines regulator says the loss of experienced staff and the need to recruit and train new assessors resulted in temporary delays to clinical trial applications, but the crisis measures it put in place to address the situation mean it has now turned the corner.
The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.