[co-author: Vicky Vlontzou]

On 12 June 2020, the management board of the European Medicines Agency (EMA) announced December 2021 as the date of entry into application of the EU Clinical Trials Information System (CTIS). This date is slightly earlier than was anticipated. It means that the Clinical Trials Regulation (CTR) may finally begin to apply.

On 12 June 2020, the management board of the European Medicines Agency's announced its proposal to set December 2021 as the date of application of CTIS.

The system was originally intended to apply in September 2018 after the performance of an independent audit in 2017 to confirm the system's full functionality. Following technical difficulties, however, the audit was postponed to December 2020 with anticipation that the date of application of the CTIS would be postponed to January or even February 2022.

Although the CTR was originally adopted in 2014, its application depends on the completion of the CTIS audit and the necessary follow-up. The date of December 2021 has been welcomed by pharmaceutical companies. This means that the CTR may finally begin to apply form that date.

The CTIS, which will include a submissions portal database, will be a single-entry point for companies to submit all clinical trial information in the EU.

The management board of the EMA has endorsed the methodology and next steps to further develop the CTIS plan for application. According to the highlights of the EMA's management board meeting, a group will be responsible for prioritizing all outstanding issues related to the CTIS governance and matching the items remaining after the audit to the capacity available before the date of application and thereafter. This group will include representatives of EU Member States, product owners, sponsors as well as representatives from the EMA and the European Commission.

[View source.]