Currently applicable legislation
Legislation sets out how drug trials are approved, conducted, monitored and reported.
- UK Clinical Trials Regulations
- Human Medicines Regulations (Early Access to Medicines Scheme - EAMS)
Clinical trial regulations reform
The UK's clinical trial regulations are changing.
In April 2025 a series of proposed updates to the UK's clinical trial regulations were approved. This marked the start of a 12 month implementation period with the updated regulations coming into force in April 2026.
During the implementation period we will be publishing guidance to explain what has changed and what you need to do to be prepared.
Resources
- GOV.UK guidance on authorisation of CTIMPs
- GOV.UK guidance on regulation of ATMPs
- GOV.UK guidance on legal requirements for children’s medicines