11 October 2023

Enhanced Transparency: EMA’s Revised Rules for Clinical Trials

The European Medicines Agency (EMA) has recently updated its transparency rules regarding the publication of clinical trial information through the Clinical Trials Information System (CTIS). A key change in these rules is removing the deferral mechanism, which allows sponsors to delay data publication for up to seven years to protect personal and confidential information.


This update balances awareness with safety, with benefits for patients, clinical trial sponsors, and health care providers. Patients now have easier access to relevant clinical trial information, allowing them to make informed decisions. Sponsors of clinical trials find the process streamlined, reducing operational complexity. Healthcare providers will benefit from the user-friendly system, which will simplify access to information and patient enrolment.


These changes were driven by stakeholder feedback and experiences following the implementation of the system. The revised rules will take effect following their technical implementation in the CTIS, including the completion of its public version in the third quarter of 2024. The effective date will be communicated to users in advance to ensure a seamless transition.