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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.
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU).
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
The ACT EU workplan for 2023-2026 is now available, with updated priorities to improve the clinical trials environment in Europe.
Interested stakeholders may express their interest in becoming a member of the Multi-stakeholder platform Advisory Group by 24 November 2023.
EMA revised rules to give faster access to information in the EU Clinical Trials Information System (CTIS).
The summary report has been published as an outcome of the first ACT EU MSP workshop held in June 2023.
A workshop report outlines proposed actions for improved clinical trials in the EU during public health emergencies.
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU).
