Medicines and Healthcare products Regulatory Agency (MHRA) publish their response to the consultation on clinical trials regulation

Written By Luke Brewer

The MHRA have published their response to the consultation on UK clinical trials regulation, which ran between January and March 2022. The MHRA (and partners the Health Research Authority [HRA] and the Department of Health in Northern Ireland) received over 2000 responses to the consultation and have responded with a report outlining their proposals. These proposed changes will be the most substantial shift in UK clinical trials processes for 20 years.

As per the summary information, the MHRA will ‘take forward legislation to reform of the UK clinical trials regulatory framework that will:

  • Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone

  • Create a proportionate and flexible regulatory environment

  • Cement the UK as a destination for international trials

  • Provide a framework that is streamlined, agile and responsive to innovation”

The full response can be downloaded from the consultation page here.

Luke Brewer
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