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Following consultation with the Multi-stakeholder platform Advisory Group, new documents have been published to support sponsors in the implementation of the Clinical Trials Regulation (CTR).
500 authorised multinational clinical trials to be added over five years
COMBINE “all-in-one” coordinated assessment pilot: call open for expressions of interest until 31 August 2025.
Designation facilitates data sharing, promotes transparency and trust in clinical research
The Clinical Trials Information System now supports submission, assessment and oversight of all trials in the EU
The ACT EU workplan for 2025-2026 outlines the initiative's areas of focus, which reflect feedback from stakeholders.
The enhanced portal aims to benefit the public by making it easier to search for publicly available information on clinical trials in the EU and EEA.
Revised rules for Clinical Trials Information System (CTIS) become applicable.
Pilots are part of ACT EU collaboration to foster high-quality clinical research in the EU.
The revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal.
