The long-awaited EU Clinical Trial Portal has hit a snag, and its launch has been postponed until 2019.
In December 2015, the European Medicines Agency (EMA) said the database and portal would be available for independent audit by August 2017. It was envisaged that the system would come into effect “by October 2018 at the latest”. However, the agency now says it will be 2019 before the portal is operational.
“Due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed,” the agency said in a statement. “EMA is working closely with its IT service provider to ensure that corrective measures are implemented and will closely monitor progress.”
The situation was raised at the EMA Board meeting last week. It is expected that an update will be discussed at the October meeting, when a new delivery time frame is likely to be agreed.
The EU clinical trial portal and database is part of a plan to improve oversight of clinical trials in the EU, which is laid down in the EU Clinical Trial Regulation. The system will provide a single portal for licence applications and a public source of information on all clinical trials conducted in the EU.