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Changes to studies to align with new clinical trials regulations
The Health Research Authority (HRA), working in partnership with colleagues in Scotland, Wales and Northern Ireland, is introducing changes to how other types of health and social care research (non-CTIMPs) are processed and managed to align with the updated clinical trials regulations
This will promote consistency across all UK clinical research and will streamline the regulatory process, making it simpler for sponsors and researchers to earn approvals.
The HRA has published new guidance about the changes to non-CTIMPs.
Sponsors and researchers are encouraged to start preparing for the changes and to update their policies, processes and procedures ahead of the implementation date.
Amended clinical trials regulations come into force across the UK for clinical trials involving medicines (CTIMPs) on 28 April 2026. The HRA haver published a news article explaining the changes in detail.
Publication date: 3rd February 2026
