The UK’s medicines regulator, the MHRA, is readying a new notification scheme to allow the approval of low-risk clinical trials without the need for a full regulatory assessment. It is based on the principle of ensuring participant safety through risk proportionality.
The notification scheme will ensure that the participant risk is either equal to, or lower than, in standard clinical care, or takes account of information arising from the trial being already underway, completed or approved to commence in the US or the EU, according to the MHRA’s
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