Changes to regulatory framework for clinical trials will benefit patients, the NHS and the Life Sciences sector

The amended regulatory framework will speed up trial approvals and encourage innovation in trial design without compromising patient safety.

New legislation has been approved in Parliament today that will address the research sector’s need for a more efficient, streamlined and adaptable regulatory framework for clinical trials. 

It will make Wales and the UK a more attractive place to conduct research and will help to get potentially life-changing new treatments to patients and the NHS as quickly as possible.

This marks an important milestone in the Medicines and Healthcare products Regulatory Agency’s biggest overhaul of the clinical trial regulations in 20 years.. 

The new legislation aims to reduce unnecessary administrative burdens on trial sponsors without compromising patient safety. It will see duplicative requirements removed and processes streamlined, with the introduction of the combined review and notification scheme for some clinical trial initial applications and amendments embedded into law.

This reform will:

• 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 addition, the International Council for Harmonisation, (ICH) guidelines on Good Clinical Practice is being updated. The UK Clinical Trial Regulations incorporate the changes in GCP to ensure we are working to the highest standard globally.

Dr Nicola Williams, National Director of Support and Delivery at Health and Care Research Wales, said: 

The approval of these regulatory changes are just one step in our national efforts to make Wales and the UK as attractive as possible to conduct and deliver high quality research studies to time and on target."

“We’re working closely with support and delivery staff in Wales to share guidance on how to implement these new trial regulations and our training courses are being updated to reflect these latest changes. 

“Over the next 12 months, the training and approval teams at Health and Care Research Wales will be on hand to support the changes before they are in place and legally binding in Spring 2026.”

In addition, the MHRA and HRA are producing detailed guidance designed to provide more detail on the amended Clinical Trial regulations in May. 

The guidance explains what will change in terms of processes, legal requirements and expectations to help researchers and sponsors prepare for when the regulations come into force in April 2026 and how to embed meaningful public involvement in clinical trials and increase the diversity of people taking part and shaping in research.

HRA is looking for feedback to ensure the final guidance is clear and easy to understand what you need to do. 

If you would like to be involved in reviewing the draft guidance before it is published in May, you can download a copy of the draft guidance and  complete an online survey. 

You don’t have to share feedback on every section of the draft guidance, just skip to the relevant sections in the survey and add your comments. 

The deadline for sharing your feedback is 17:00 on Wednesday 23 April 2025.