Last updated: 19 December 2024
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New clinical trials draft legislation (Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024) was laid in Parliament today, 12 December 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.
Once it becomes law, when will the new legislation come into force?
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.
What are the expected benefits of the new legislation and regulatory framework for clinical trials?
These reforms 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.
- 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.
What are some of the key amendments expected to be introduced?1
Some of the key amendments expected to be introduced include:
- Proportional regulation of lower risk clinical trials (deemed ‘notifiable trials’), including low risk trials that (together with other requirements) have been approved by a licensing authority in the European Union, an EEA state or the USA.
- Notifiable trials will require only a notification to the MHRA and not an approval.
- Research Ethics Committee approval will still be required.
- Other flexibilities to lower risk clinical trials include simplified means for seeking and recording consent and a risk-adapted approach for labelling.1
- The combined review process for both MHRA and Research and Ethics Committee approval will be introduced into law.1
- New transparency requirements will apply requiring registration of clinical trials in the WHO recognised public register, and publication of trial results in this public register within 12 months of the end of the trial. It will be possible to apply for deferral of the publication requirements for a period of up to 30 months to protect commercially confidential information.1
- Archiving periods for trial master files will be extended from 5 years to 25 years.1
- The introduction of a sunset period on approvals whereby clinical trial approvals will lapse after a proposed sunset period of two years if no participants have been enrolled.1
- The introduction of requirements for non-investigational medicinal products including that they are manufactured in accordance with good manufacturing practice (GMP) and meet certain labelling requirements.1
How were these reforms developed?
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.
Will there also be new guidance published in addition to the new clinical trials legislation?
Yes, 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.
Statement made in parliament by Baroness Merron
Here is a link to the statement made in parliament by Baroness Merron on 12 Dec 2024 concerning laying of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 before Parliament.
References
1. Framework amending the UK clinical trial regulations laid before Parliament, Jane Summerfield et al, 17 December 2024, Hogan and Lovells