Currently applicable legislation
Legislation sets out how drug trials are approved, conducted, monitored and reported.
- GOV.UK guidance on authorisation of CTIMPs
- GOV.UK guidance on regulation of ATMPs
- GOV.UK guidance on legal
requirements for children’s medicines
- European Commission clinical trials guidelines
The new EU Clinical Trials Regulation will:
the electronic submission and assessment process
collaboration, information-sharing and decision-making between and within EU member states
transparency of information on clinical trials
the highest standards of safety for all participants in clinical trials
- guidance for sponsors who have agreed to test developments with us is available on our combined ways of working pilot page.
We are preparing for the new Regulation while the UK is still an EU Member State, alongside working with partners to maximise the opportunities of different Brexit negotiation outcomes.