EMA Publishes revised CTIS Transparency Rules

Recommendation

27-29 February 2024

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Management, Supply and Quality Assurance of Clinical Trials

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.

Key Changes

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:

• Early publication of key clinical trial information, that patients flagged as being most relevant for them.
• Process simplifications for clinical trial sponsors who have to protect CCI and personal data.
• More user-friendly system for healthcare professionals, facilitating access to information about clinical trials and enrolment in clinical trials, and also increasing awareness of possible treatment options.

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.

More information is available in the Revised CTIS transparency Rules, which have been published on EMA website together with the news announcement.