EU CTIS Proposed Go-Live Date December 2021

At the EMA Management Board June 11th meeting, the Board endorsed the methodology and next steps to develop further the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation ‘go-live’ plan.

A group including representatives of the Member States, sponsors, as well as representatives from EMA and the European Commission will be responsible for prioritising all outstanding issues to the CTIS governance. For the prioritisation exercise, as a working assumption, it is proposed to fix the go-live date of CTIS to December 2021.

The Board noted that further operational assessments of various elements of CTIS were carried out in May, including the public portal and the publication of documents, and that the supplier progressed in the development of CTIS.

In view of the upcoming start of the audit in December 2020, a key milestone for CTIS, the Board decided to extend the monitoring of agreed key performance indicators until after the CTIS audit.

The CTIS go-live date of December 2021 is slightly earlier than had been forecast (January/February 2022), and it should come as a major relief for drug companies as it offers clarity that the Clinical Trials Regulation (CTR) can finally start applying from that date.