Proposals for legislative changes for clinical trials - GOV.UK

"The Medicines and Medical Devices Act 2021 provides the powers to update the legislation for clinical trials. This brings the opportunity, having left the European Union, to design a world-class sovereign regulatory environment for clinical trials that will support the development of innovative medicines and ensure that the UK retains and grows its reputation as world leading base for life sciences, generating opportunities for skilled jobs in the UK. This consultation outlines a set of proposals, capitalising on this opportunity, to reframe the UK legislation for clinical trials, responding to the needs of the sector to deliver a more streamlined and flexible regulatory regime, whilst protecting the interests of patients and trial participants.

This consultation specifically relates to clinical trials and the medicinal products used in clinical trials (Investigational Medicinal Products, ‘IMPs’). These proposals are to update the current UK legislation that governs clinical trials, The Medicines for Human Use (Clinical Trials) Regulations 2004” (SI 2004/1031), as amended, which transposes the EU Clinical Trials Directive 2001/20 EC into UK law.

Through the legislative proposals in this consultation, we aim to enable a thriving clinical research environment in the UK, reflecting innovative trial design and delivery and supporting the wider programme of work being taken forward as part of the UK vision for the future of clinical research delivery in Saving and Improving Lives: The Future of UK Clinical Research Delivery and its implementation as well as the Life Sciences Vision. These proposals also take steps to remove bureaucracy to support an efficient and effective clinical trials environment, in line with recommendations from the Taskforce for Innovation, Growth and Regulatory Reform (TIGRR) and support faster access to new, innovative treatments for patients.

We are seeking the views of clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, healthcare professionals, and the wider public to help shape improvements to the legislation for clinical trials...."