July 2021: EMA Management Board Meeting on CTIS Audit

European Medicines Agency (EMA) published a document on the minutes of the management board meeting on the Clinical Trial Information System (CTIS) audit on July 14, 2021.

The meeting was held virtually on April 21, 2021. The main aim of this meeting was to confirm if the EU clinical trials Portal and Database (EUPD) are fully functional and meet the functional specification. EUPD is one of the deliverables and a key component of the Clinical Trials Information System (CTIS).

Publication of the European Commission (EC) notice confirming full functionality of the EUPD will start as soon as the Management Board letter of endorsement is received. The Commission will draft an act that is intended to be published on 31 July 2021, so that the Clinical Trials Regulation can start to apply 6 months later. Also, a Joint Action for clinical trials will be launched by the EC in 2021. Additionally, the EC declared that they would be providing the legal support required for the national implementation of Regulation (EU) No 536/2014.

The timelines of the CTIS application were reemphasized in the meeting. The system is set to go live by 31 January 2022 and in the first year after CTIS is live, the sponsor will have a choice to select the old or new system. From 31 January 2023, all the new applications will be submitted to the new system, and the old system will be available only for ongoing studies. From 31 January 2025, all the ongoing studies will need to move on to the new system and the EU Directive will no longer apply.

The document also provides a summary of EUPD independent audit methodology and findings, project release plan for go-live and post-go-live, CTIS training and communication programs and confirmation on EUPD functionality as per the Clinical Trial Regulation.

Detailed information on the above-mentioned points can be found here.

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