From 28 April 2026, new regulations for clinical trials of investigational medicinal products (CTIMPs) will come into effect.
In October 2025 we issued final guidance to support researchers and sponsors ahead of legal changes to how CTIMPs are run in the UK.
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.
However the HRA, in collaboration with the other UK nations, has been considering how non-CTIMP applications can be better processed and managed based on the changes brought in by the updated regulations.
These are not legal changes but will help make sure there's better process alignment between CTIMPs and non-CTIMPs and promote consistency across all UK clinical research.
The changes will 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, we will set out how they should be followed to support transparency, patient safety and research integrity. For other types of research we will clarify where aligning with policy changes is encouraged.
To help you understand and prepare for the changes, we have developed guidance that outlines the following:
- 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.