EMA starts Review of Transparency Rules for the CTIS

The European Medicines Agency (EMA) had launched a public consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS). Stakeholders were invited to send their comments via an online form by end of June 2023. According to the Agency, the consultation intended to collect views from system users and stakeholders and stimulate discussions on the best possible approaches to balance transparency of clinical trials data in CTIS with confidentiality requirements, while also simplifying the modalities of use of the new system.

Protection of Personal Data and Commercially Confidential Information

Any changes in the CTIS functionalities that might be required following the public consultation will maintain the high benchmark for transparency provided by the Clinical Trials Regulation (CTR). The simplification of the rules is meant to reduce administrative burden for public authorities and sponsors, but they will not entail decreased protection of personal data and commercially confidential information (CCI). Following the public consultation, any revision to the transparency rules will be presented to the Agency’s Management Board for approval and intended implementation before the end of 2023.

Interim Guidance Document

In addition to the public consultation an interim guidance document and its annex have been published. The interim guidance document and the annex are intended for CTIS users and have been revised following the public consultation carried out in 2022. It is available to assist clinical trial sponsors and authorities in fulfilling the obligations set out in the CTR. Finalisation of this guidance based on the current transparency rules is expected in the third quarter of 2023.

For more information please see EMA's Review of transparency rules for the EU Clinical Trials Information System (CTIS) website.