Sponsors should plan to transition existing clinical trials into the new Clinical Trial Information System (CTIS) portal by 30 January 2025, Anabela Marcal, of the European Medicines Agency (EMA), told attendees at RAPS Convergence 2023.
Marcal, who serves at the EMA liaison to the US Food and Drug Administration (FDA), provided an update on the CTIS, along with practical regulatory considerations for planning and conducting clinical trials in Europe
.
The CTIS portal, which launched in 2022, replaced the EudraCT portal in January 2023. Clinical trial sponsors are now required to use the portal to apply for authorization to run a new trial. The deadline for transitioning ongoing trials to the new portal is 30 January 2025.
In the meantime, EMA has also released new transparency rules governing the protection of commercially confidential relationships under the Clinical Trials Regulation. These new rules aim to simplify the reporting for CTIS users…
