FINAL APPROVAL EU PORTAL AND DATABASE BY EMA’s MANAGEMENT BOARD
Great news upcoming!
Yesterday, EMA’s Management Board confirmed that the clinical trial EU Portal and Database, is now fully functional and on track to go live by 31 January 2022.
In order to comply with the schedule, the European Commission must verify that all Clinical Trial Regulation have been met and publish the outcome in the Official Journal of the European Union on 31 July 2021. Six months after this publication, the Clinical Trial Regulation will start to apply and CTIS will go live.
When CTIS is available, it will be the single entry point for clinical trial applications in European Union. Furthermore, sponsors will be able to apply for a clinical trial in all countries of the European Economic Area (EEA) at the same time rather than to apply in every country.
More information can be found here: https://www.ema.europa.eu/en/news/clinical-trials-information-system-reaches-major-milestone-towards-go-live-application-clinical.