On 28 April 2025, the United Kingdom (UK) Parliament and Northern Ireland Assembly approved the The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
These new regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004 which currently govern the regulation of clinical trials involving investigational medicinal products (CTIMPs) in the UK.
The changes to the regulations are based on feedback from a public consultation in 2023, which included input from various stakeholders on beneficial changes to the existing legislation.
While Parliament has approved the updates, the new regulations will not come into force until 28 April 2026. This means that CTIMPs will continue to follow the Medicines for Human Use (Clinical Trials) Regulations 2004 until 27 April 2026.
The existing guidance on the HRA website will give you up to date information on how you should submit, manage and conduct CTIMPs in compliance with the 2004 regulations.
When the new regulations do come into force, they will apply across all four nations of the UK (England, Wales, Scotland and Northern Ireland). All clinical trials taking place in the UK will be required to comply with the updated regulations.
To help you understand and prepare for the new requirements, we have developed guidance that outlines the changes:
- definitions and terminology
- research transparency requirements for clinical trials
- the approvals process for clinical trials
- Research Ethics Committees that review clinical trials
- simplified arrangements for consent in clinical trials
- pharmacovigilance
This guidance sets out the changes to the REC and MHRA review process for CTIMPs in line with the new clinical trials regulations.
It does not detail any other review processes CTIMPs may need, such as HRA and Health and Care Research Wales (HCRW) Approval, or how the review process for non-CTIMPs will change.
This is because only the REC and MHRA review process for CTIMPs is within the remit of the clinical trials regulations and is directly impacted by the new legislation.
If changes are made to the processes and timelines for other reviews of CTIMPs, or to the review processes and requirements for non-CTIMP applications, we’ll share separate guidance and information with you.
MHRA guidance
We also recommend you read the guidance produced by the Medicines and Healthcare products Regulatory Agency (MHRA) to help you understand what will change when the new regulations come into force.
Good clinical practice (GCP) for clinical trials
The updates to the clinical trials regulations will include changes to Part 4 (GCP and the conduct of clinical trials) of the existing legislation.
This will include introducing a legislative requirement for CTIMPs to comply with the conditions and principles in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice.
These changes will apply to all CTIMPs from 28 April 2026, regardless of whether they were submitted before or from this date.
The MHRA will be producing detailed guidance further explaining the changes relating to GCP conduct for clinical trials in the coming months.
Share your feedback
If you have any feedback on this guidance, please complete our online survey.
All feedback is welcomed and will be considered when planning our future work and guidance changes relating to the new regulations.
If you would prefer to provide your feedback on how our guidance is written by email, or you have any questions, please email the HRA's engagement team.