Entry into Application of EU Clinical Trial Regulation Postponed to 2019

The EU clinical trial portal and database supports the ambitious modernisation of the processes for authorisation and oversight of clinical trials in the EU

The European Medicines Agency (EMA) Management Board discussed at its June 2017 meeting the progress made regarding the development of the EU clinical trial portal and database. Due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed.

EMA is working closely with its IT service provider to ensure that corrective measures are implemented and will closely monitor progress. The EMA Management Board was informed about the mitigation measures taken and the revised plan from the developer.

The Agency 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.

EMA’s priority is to ensure that a high quality and functional system is delivered to the EU regulatory network and its stakeholders.

The EU clinical trial portal and database supports the ambitious modernisation of the processes for authorisation and oversight of clinical trials in the EU laid down in the EU Clinical Trial Regulation. The system will provide a single portal for submission and maintenance of clinical trial applications and authorisations, and support coordinated assessment and supervision. The portal and database will also serve as the source of public information on the full lifecycle of all clinical trials conducted in the EU, from their initial review up to the publication of their results.

This is the most ambitious IT system required by the EU legislation in the last decade, involving a complete EU-wide system to be used for clinical trial applications, urgent safety measures and other notifications to regulators before, during and after the conduct of clinical trials.