On October 5, 2023, the EMA adopted revised rules on transparency for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS). [Source: EMA – Revised Transparency Rules]

The public consultation, conducted in May and June 2023, aimed to analyze and review the transparency rules for CTIS. This process considered feedback from stakeholders and the initial experiences of system users. The goal is to publish clinical trial information for the benefit of patients, supporting access to treatments and innovation.

Changes to CTIS, based on public consultation feedback, will simplify transparency rules, making the system more efficient and user-friendly while ensuring compliance with CTR requirements. The revisions include:

  • Publishing relevant clinical trials information (structured data fields and documents) for the public in the EU/EEA.
  • Implementing changes to help the public easily identify information on the CTIS public website.
  • Rationalizing the published documents to reduce complexity and workload, while maintaining essential information for patients and researchers.
  • Removing the deferral mechanism for every trial category, leading to earlier publication of key documents, including protocols.

These transparency rules will apply after their technical implementation in CTIS, expected to be finalized in the second quarter of 2024. The effective date of completion and the entry into application of the new rules will be communicated to system users before they become applicable.

Regarding CTIS:

Starting on January 31, 2023, the use of CTIS becomes mandatory for new clinical trial applications, serving as the single-entry point for submission by sponsors and for regulatory assessment. It facilitates interactions between clinical trial sponsors and regulatory authorities in EU Member States and EEA countries throughout a clinical trial’s lifecycle. [Source: EMA – Revised Transparency Rules]

Roxana Darie, MBL
Managing Director / Legal Affairs EU