Following public consultation, MHRA to streamline clinical trial approvals in biggest overhaul of trials regulation in two decades

Last updated:16 August 2023

See updates at the end of the post.

The UK MHRA will introduce a series of new measures with support from partners to make it faster and easier to gain approval and to run clinical trials in the UK.

These changes:

  • which follow a public consultation in partnership with the Health Research Authority (HRA) and the Department of Health in Northern Ireland, have been made possible with the help of the public and the research community.
  • represent the biggest overhaul in UK clinical trials regulation in over 20 years and will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers.

Under the new framework:

  • clinical trials application processes in the UK will be more proportionate, streamlined and flexible without compromising on safety, helping to cement the UK as an attractive destination for trials, including global “multi-site” trials e.g. 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, will be embedded into the new regulation.
  • a timeline will be implemented for completion of an application review within a maximum 30 days in general, with a maximum 10 calendar days for a decision to be granted once the regulator has received any final information.
  • for transparency,  a legal mandate will be introduced to register the trial in a World Health Organisation (WHO) public register, and a requirement to publish a summary of results within 12 months of the end of the trial. Sharing trial findings with participants in a timely manner and suitable format will also be required by law.

The legislative changes will result in a regulatory framework that is as future-proof as possible, responsive to different types of trials and innovative designs, and supportive of new ways of carrying out trials such as decentralised trials.

  • Comprehensive new guidance, co-designed with these stakeholder groups, will be introduced to accompany the new legislative measures.
  • This will ensure that UK clinical trials truly work in partnership with patients and the public and are representative of the diversity of people who may benefit from the medicine if the data generated ultimately lead to regulatory approval.
  • The guidance will outline how to include patients meaningfully into the design and conduct of trials, and how to achieve diversity in trials in a way that is proportionate and achieves the best results.
Is there a timeline available of the proposed changes to the UK regulatory framework for clinical trials?

Yes there is and you can view it in this post.

Source: MHRA

16 Aug 2023Following section added:

Is there a timeline available of the proposed changes to the UK regulatory framework for clinical trials?