After two years of working with the Medicines and Healthcare Products Regulatory Agency (MHRA), the statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 has been placed before Parliament. These changes are set to come into play in early 2026.
Updating this crucial law started in 2022 with a public consultation which asked for feedback on how the regulation of clinical trials could be improved and strengthened in the UK.
The new legislation is intended to support more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens whilst protecting the interests of trial participants.
The key updates are as follows:
- The regulations puts Combined Review - the way research teams seek approval from a Research Ethics Committee and the MHRA for new clinical trials into law for the first time - to create a single process, reducing the wait time of approvals.
- Under the regulations, it will be a requirement to register clinical trials in a World Health Organisation (WHO) public register and to publish a summary of results within 12 months of the end of the trial to ensure full transparency.
- The regulations also include the ability to use simplified methods of seeking and recording consent in “lower-risk” trials (i.e. those trials involving medicines that have already been approved and therefore post minimal risks to participants).
- The regulations also provide guidance that will ensure clinical trials reflect a diverse population, with a focus on public engagement in trial design.
These changes will contribute to the UK’s clinical research industry, which adds over £7 billion annually to the economy. The government is also investing £100 million of public-private funds in 20 new research hubs revolutionise and improve access to treatments.
Sharado Parbhoo, Paralegal Consultant says: “Clinical trials are based on trust and the new regulations set out clearly what researchers should do to give trial participants the confidence to choose to take part in a clinical trial. The regulations aim to make UK clinical trials more efficient, transparent, and inclusive, benefiting both patients and researchers.”
Reference:
New clinical trials regulations laid in parliament today - Health Research Authority
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