Clinical Trials Regulation in the EU

by | Jan 27, 2022 | Regulatory Affairs, Regulatory Intelligence | 0 comments

Clinical Trials Regulation in the EU

The Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into application on 31 January 2022 and the Clinical Trials Information System (CTIS) is due to go live on this date. 

What are the aims of the new Clinical Trials Regulation?

  • To create an environment that is favourable to conducting clinical trials in the EU and ensure the highest standards of safety for participants; through ensuring consistent rules for conducting clinical trials throughout the EU
  • To increase transparency of trial information; information on the authorisation, conduct and results of each clinical trial is to be publicly available

What are the benefits of the new Clinical Trials Regulation?

  • For EU Member states:
    • harmonised electronic submission and assessment process
    • improved collaboration, information-sharing and decision-making
  • For the public and patients:
    • increased transparency of information
    • highest standards of safety for all participants

What is the Clinical Trials Information System (CTIS)?

CTIS will be the single entry point (regulatory and ethics) for submitting clinical trial information in the EU, which will be stored in the system. European Medicines Agency (EMA) will make information stored in CTIS publicly available subject to transparency rules.
CTIS will have 3 sections:
  • Sponsor workspace – A secure workspace that will assist clinical trial sponsors in preparing and compiling data to submit to the system for assessment by Member States.
  • Authority workspace – A secure workspace that will support the activities of Member States and the European Commission in overseeing clinical trials.
  • Public website – Members of the public can access detailed information on all clinical trials conducted in the EU, in all official EU languages. 

What training is available for CTIS?

The following training is available to help you prepare for using CTIS:

Are you ready for the Clinical Trials Regulation (Regulation (EU) No 536/2014)?

If you would like to discuss how Fusion Pharma can support you with Clinical Trial Applications, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.