Guidance on changes to the clinical trials regulations

On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved 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 updated legislation will come into force on 28 April 2026. For further information on the changes we recommend you access the dedicated guidance published on the MHRA and HRA website.