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Clinical Trials of Investigational Medicinal Products (CTIMPS)

Last updated on 16 Oct 2018

Currently applicable legislation 

Legislation sets out how drug trials are approved, conducted, monitored and reported. 

Resources 

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 

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