New regulations for clinical trials of investigational medicinal products (CTIMPs) came into effect on 28 April 2026.
The amended clinical trials regulations do not cover changes to clinical trials that test the safety and effectiveness of patient interventions such as medical devices, surgical techniques, public health measures and behavioural therapies research and other types of health and social care research. These types of studies are referred to as non-CTIMPs.
The HRA, working in partnership with other UK organisations that support research, has introduced changes to how non-CTIMPs are processed and managed to align with the updated clinical trials regulations.
These are not legal changes but help make sure there's better process alignment between CTIMPs and non-CTIMPs and promote consistency across all UK clinical research.
The changes apply across all 4 nations of the UK (England, Wales, Scotland and Northern Ireland) from 28 April 2026.
These changes reflect UK-wide expectations and, while not enforceable by law, this guidance sets out how they should be followed to support transparency, patient safety and research integrity. For other types of research this guidance clarifies where aligning with policy changes is encouraged.
Our guidance outlines the following changes:
- updates to ‘amendment’ terminology for non-CTIMPs
- the approvals process for non-CTIMPs
- the approvals process for non-CTIMP modifications (amendments)
- research transparency requirements for non-CTIMP clinical trials
It does not detail any other review processes that non-CTIMPs may need, such as HRA and Health and Care Research Wales (HCRW) Approval.
For more information about the changes to CTIMPs, read our clinical trials regulations guidance.