Background

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates the available medicines, medical devices and blood components for transfusion in the UK. They use science and data to:

• Ensure safety, quality and effectiveness.
• Ensure a secure and safe supply chain.
• Advocate for international standardisation and harmonisation.
• Educate public and healthcare professionals regarding risks and benefits.
• Enable beneficial innovation, research and development.
• Collaboration with (inter)national partners to allow easy and early access to products.

MHRA directs regulatory policies, securing public health and are constantly striving for improvement. They are recognized globally as an authority in its field.

Streamline Clinical Trial Approvals

In the biggest shake-up of over 20 years in UK clinical trials regulation, the MHRA will introduce new measurements to make clinical trials more proportionate, streamlined and flexible without compromising on safety. These changes will lead to a faster and easier gain of approvals and make it easier to run clinical trails in the UK.

An example of this, is combining the regulatory and ethics review in the pilot phase of the clinical trial application. This will lead to a 50% reduction of the approval time for studies and reduce the time from application to recruitment of the first patient by 40 days. Another example is the implementation of legislative changes that will support a wider range of trail types and innovative designs, moving away from the previously one-size-fits-all approach.

Summary

The overhaul of the UK clinical trials regulation by MHRA will help make the UK an attractive place to conduct clinical research. It will speed up the trials and help develop better treatments for patients.

For more information on this topic please click the link below

MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years – GOV.UK (www.gov.uk)