The amended regulatory framework will speed up trial approvals and encourage innovation in trial design without compromising patient safety
New legislation is being laid 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 the UK a more attractive place for innovators to conduct important 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, and will support taking trials to the patient.
The new legislation, which once made into law will come into force following a 12-month implementation period to ensure readiness, 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.
These changes are being introduced with support from health system partners including the Health Research Authority (HRA), academia and researchers.
Dr June Raine, MHRA Chief Executive said:
A major milestone for clinical trials regulations has been achieved today.
After extensive public consultation and expert input, we're introducing regulations that eliminate unnecessary duplication and accelerate approvals.
These reforms protect the safe development of pioneering new treatments for the benefit of patients and the NHS, setting the UK as one of the best places in the world to conduct research for patients, researchers and innovators.
Dr Matt Westmore, HRA Chief Executive said:
Good clinical trials can speed up diagnosis, improve treatment and enable the NHS to provide world-class care. This legislation will make it easier to do clinical trials with and for everyone, making the UK a world-leading destination to do clinical research and ensuring everyone benefits.
The new regulations signal the UK's high expectations for how clinical trials should be conducted and set clear requirements for research transparency. When the new law comes into force, supporting guidance will ensure that everyone understands what is expected and how to do it.
These reforms 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.
The reforms were developed through a series of stakeholder workshops, seeking the views of a wide range of organisations and individuals from across the clinical research sector, including patient representatives. A public consultation took place in January to March 2022, to which over 2,000 responses were received, and the Government response was published in March 2023.
Alongside the regulations, the MHRA and HRA are producing guidance to embed meaningful public involvement in clinical trials and increase the diversity of people taking part in research trials. This will ensure that research findings can improve everyone's care, helping address health inequalities, because the UK is one of the best places in the world to do research that people can trust.
Modernising the regulatory framework will strengthen the UK's standing as a prime destination for conducting groundbreaking, safe clinical trials. This aligns with recommendations from the Lord O'Shaughnessy Review , further emphasised in Lord Darzi's Independent Investigation of the NHS in England, to make the UK more attractive for commercial clinical trials.
To prepare the clinical trial community for the upcoming changes and facilitate a smooth transition to the new regulations, guidance will be developed through engagement with a wide range of stakeholders and will be published during the implementation period.
Notes
- Since September 2023 regulatory assessments of clinical trials applications have been completed by the MHRA within statutory timeframes (30 days or less).
- The MHRA announced its notification scheme for the lowest risk trials in October 2023 and has published a case study on this.
- The MHRA announced its notification scheme for the lowest risk trials in October 2023 and has published a case study on this.
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
