EUROPEAN MEDICINES AGENCY - Transparency rules in CTIS

The public consultation on the CTIS transparency rules, which was launched on 3 May 2023, concluded on 28 June 2023. Over 200 responses were received from CTIS users and stakeholders. The feedback reflects diverse views on the use of deferrals and redaction functionalities, with agreement on the need for simplification.

date: 13/09/2023

The comments received have been reviewed and proposals for changes to the transparency rules are being finalised with the aim of presenting the revised CTIS transparency rules for endorsement to the EMA Management Board in October 2023. Following the adoption of the revised rules, the functionalities of the CTIS public website will be amended accordingly.

Additionally, the final guidance document on the protection of personal data and commercially confidential information while using the current transparency rules for CTIS has been published under "Related documents" on the ACT EU website page Implementation of the Clinical Trials Regulation.