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 trials regulations reform
The UK's clinical trials regulations are changing from 28 April 2026.
We have published guidance explaining what the changes are 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