The new proposed MHRA changes are in keeping with the 27 recommendations that emerged from that 2023 review of the UK trials landscape, further emphasised in Lord Darzi‘s Independent Investigation of the NHS in England. Alongside the O’Shaughnessy review, the government published an interim response that made five headline commitments, backed by up to £121 million, and, in September 2023, the MHRA met the target of all studies receiving regulatory approval within 60 days.

Health and Social Care Secretary Steve Barclay commented that the changes “come after the government announced additional funding of £10 million for the MHRA to accelerate the delivery of cutting-edge treatments including cancer vaccines” and that they “support a wider coordinated programme of work that has been developed to ensure the 'recovery, resilience, and growth' of UK clinical research, as set out in the Government’s bold vision for The Future of UK Clinical Research Delivery.”

Marc Bailey, the MHRA’s own chief science and innovation officer, stated of the UK: “Our world-first COVID-19 approvals showed how important it is to ensure that regulation is flexible and agile. This overhaul of the clinical trials legislation will do just this – it will move us away from a one-size-fits-all approach to the regulation of clinical trials and help to streamline approvals by removing granular and duplicative regulatory requirements.”

Additionally, a timeline will be implemented for completion of an application review within a maximum of 30 days in general, with a maximum 10 calendar days for a decision to be granted once the regulator has received any final information. Aiming for a regulatory framework that is as ‘future-proof’ as possible, it takes into consideration multiple different types of trials and innovative designs, and supportive of new methods, such as decentralised clinical trials (DCTs).

These changes follow a public consultation held January to March 2022, in partnership with the Health Research Authority (HRA) and the Department of Health in Northern Ireland. Over 2,000 responses from individuals and organisations from the UK and across the world were received and carefully considered and the MHRA will now work collaboratively with patients and the research community to ensure these changes are implemented as quickly as possible.

Dr Matt Westmore, chief executive of the HRA, perhaps said it most simply: “Good clinical trials can speed up diagnosis, improve treatment, and enable the NHS to provide world-class care.” Thus, the reforms aim to:

• Promote public health and ensure protection of participants remains at the heart of legislation
• Facilitate the evaluation and development of new or better medicines to benefit patients and society, and improve public health
• Remove obstacles to innovation, whilst maintaining robust oversight of the safety of trials
• Streamline the regulation of clinical trials and reduce unnecessary burden to those running trials by taking a risk-based approach
• Ensure the legislation enables trial sponsors to work across countries so that the UK remains a preferred site to conduct multi-national trials.

In January 2025, Informa Connect reported that the proposed changes to the rules that govern clinical trials in the UK would require sponsors to register on a World Health Organization (WHO) public database within 90 days of gaining regulatory approval or when they recruit the first participant (whichever happens sooner) and share results with participants. There will then be the legal requirement to publish a summary of results within 12 months of the end of the trial.

Commenting on the government’s announcement of the new legislation to create a more efficient, streamlined, and adaptable regulatory framework for clinical trials, Matthew Alderton, partner in the health and life sciences team at UK and Ireland law firm Browne Jacobson, said the “new legislation will be welcomed with open arms by the life sciences industry, which has for a long time been calling for measures to streamline the slow and cumbersome clinical trials process.”

Alderton added: “By removing granular and duplicative requirements in the proposed new framework, standardising the approvals and contracting process to reduce set-up times, and providing more flexibility at a broader level to the clinical research environment, there is real hope this can drive new inward investment and international market entrants into UK life sciences.”

For patients, Alderton noted that “breaking down barriers to participation in clinical trials could also have a profound impact on tackling health inequalities, as widening and diversifying the pool of participants will ensure new treatments are being tested on people from all walks of life, rather than a narrow sample.”

Separately under consultation at the moment until 31st March – and further evidence of the MHRA’s awareness of the need for modernisation of some of its processes – is guidance on personalised cancer vaccines, with the main question being ‘What change is allowed?’. Speaking at RNA Therapeutics 2025 in London, Ka-Wai Wan, pharmaceutical assessor at the MHRA, noted the need for “a platform to fit all.” Yet, understanding of nuance – for example, the difference between an infectious disease and a personalised cancer vaccine – is important and flexibility crucial.

Clinical trials are, she said, a controlled population, and whilst how patients will use products cannot be controlled, discovery, approval, and monitoring can be carried out fastidiously: ‘risk-to-benefit balance’ is ever a key concern.