27-29 February 2024
Following the public consultation on the revision of the transparency rules for the Clinical Trials Information System (CTIS), the European Medicines Agency (EMA) has now endorsed the revised transparency rules. According to the agency, the simplifications introduced will give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way.
One of the key changes of the revised rules is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect personal data and commercially confidential information (CCI).
According to the EMA, the updated rules strike a balance between transparency of information and CCI protection. The following goals have been achieved:
The revised transparency rules will apply after their technical implementation in CTIS, including its public portal, which is expected to be finalized in the second quarter of 2024. The effective date of completion of the process and the entry into application of the new rules will be communicated to the users of the system before they become applicable.