The EU Clinical Trial Regulation implementation was foreseen in October 2018. Due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed. The European Medicines Agency (EMA) will provide an update at the next meeting of the Management Board in October 2017 where a new delivery time frame will be discussed once progress with development has been confirmed. Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled.
22 June 2017