Regulatory News

Application of EU Clinical Trial Regulation Delayed to 2019

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

"Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled," EMA said Friday.

The agency says it will provide an update at the next meeting of the Management Board in October 2017, following closer work with its IT service provider to ensure corrective measures are implemented.

The EU clinical trial portal and database are part of a modernization of the processes for authorizing and overseeing clinical trials in the EU.

The new system will eventually offer a single entry point for clinical trial submissions and the maintenance of applications, as well as authorizations. The portal and database will also serve as the source of public information on the lifecycle of clinical trials conducted in Europe, from initial review to the publication of 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," EMA said.

EMA Management Board: highlights of June 2017 meeting