Currently applicable legislation
Legislation sets out how clinical trials of investigational medicinal products (CTIMPs) are approved, conducted, monitored and reported.
- The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
- Human Medicines Regulations (Early Access to Medicines Scheme - EAMS)
Clinical trials regulations reform
The UK's clinical trials regulations have changed.
In April 2025 a series of proposed updates to the UK's clinical trials regulations were approved. This marked the start of a 12 month implementation period with the updated regulations coming into force on 28 April 2026.
Where possible the HRA, in collaboration with the other UK nations, has aligned the updates to clinical trials and other health and social care research which are not regulated under the clinical trials regulations.
Resources
- clinical trials regulations reform
- GOV.UK guidance on authorisation of CTIMPs
- GOV.UK guidance on regulation of ATMPs
- GOV.UK guidance on legal requirements for children’s medicines