UK MHRA to streamline clinical trial approvals in significant overhaul of trial regulation

Medicines and Healthcare products Regulatory Agency hopes legislative changes will help make UK one of the best countries in the world to conduct clinical research – for patients and researchers.

A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster and easier to gain approval and to run clinical trials in the UK.

My take on this: Similarly to the FDA in the US, the MHRA is the medical regulatory body in the UK responsible for the licensing of medications depending on their efficacy following clinical trials. The agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.

The MHRA, in collaboration with the Health Research Authority (HRA) and the Department of Health in Northern Ireland, looked at 2,000 responses from individuals and organisations from the UK and across the world received through the public consultation on proposals for legislative changes for clinical trials. The upcoming changes implements as a result of this consultation represent the biggest overhaul in UK clinical trials regulation in over 20 years and the MHRA hopes they will help to make the UK one of the best countries in the world to conduct clinical research, both from a research and a patient perspective.

Under the new framework, clinical trials application processes in the UK will be more proportionate, streamlined and flexible without compromising on safety; the MHRA says this will help to cement the UK as an attractive destination for trials, including global “multi-site” trials. It cites, as an example, the integration of the regulatory and ethics reviews of clinical trial applications, which in pilot phase halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days; this new approach will be embedded into the new regulation.

Get to know more about these changes being brought about by the MHRA, HERE.

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