Clinical Trials of Investigational Medicinal Products (CTIMPS)

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
  
• European Commission clinical trials guidelines
  

Future developments 

The new EU Clinical Trials Regulation will:

• harmonise the electronic submission and assessment process
  
• improve collaboration, information-sharing and decision-making between and within EU member states
  
• increase transparency of information on clinical trials
  
• ensure 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.

Resources 

• European Commission information about the EU Clinical Trials Regulation