June 2021: EMA Management Board Meeting

EMA published the highlights from June 2021 Management Board meeting on June 18, 2021. Below is the update posted regarding EU CTIS:

Progress on EU IT systems required by the Clinical Trial Regulation

The Board welcomed the progress in the development and preparations for ‘go-live’ of the Clinical Trial Information System (CTIS). Following the independent audit reported in April 2021 and the endorsement on full functionality of CTIS by the Board, the publication of the Commission decision is anticipated for 31 July 2021 in the Official Journal of the European Union and go-live is currently on track for 31 January 2022.

The development of CTIS continues as planned and EMA, together with Member States and sponsor experts, are heavily engaged in working on the agreed functionalities for the go-live version of the system.

More information can be found here.

Leave a Reply