Welcome to the April 2024 issue of Clinical Trials Highlights.

The revised CTIS transparency rules will become applicable on 18 June 2024, following their adoption by the EMA Management Board in October 2023. 

The updated rules strike a balance between transparency of information and protection of commercially confidential information. They benefit patients, ensuring key clinical trial information, that patients flagged as being most relevant for them, is published early. They also introduce process simplifications that benefit clinical trial sponsors who have to protect commercially confidential information and personal data.

Sponsors are advised to adapt their business processes to align with the revised rules. More information and resources are available on the ACT EU website.

The European Medicines Regulatory Network (EMRN) continues to work to support sponsors and ensure the successful implementation of the CTR, aiming to improve the EU environment for clinical trials.

-       EMA Clinical Trials Team