News 03/05/2023

EMA has opened a public consultation to review the PDF icon transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an online form by midnight (CET) on 28 June 2023.

The review of the CTIS transparency rules seeks to stimulate the discussion on the best possible approaches to balance clinical trial transparency with confidentiality requirements while simplifying the modalities of use of CTIS to improve user experience and reduce the risk of data breaches. 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 of CTIS, but they will not entail decreased protection of personal data and commercially confidential information. Following the public consultation, any revision to the transparency rules will be presented to EMA’s Management Board for approval and implementation before the end of 2023.

Interim guidance on the protection of personal data and commercially confidential information while using the current transparency rules for CTIS has been modified following public consultation and 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.

The CTR strengthens Europe as an attractive location for clinical research, by streamlining the processes for applying for authorisation and supervision of clinical trials, no matter where clinical trial sponsors are located and which national competent authority or national ethics committee they are dealing with.

The streamlined processes introduced by the Regulation are enabled by the CTIS, the single entry point for the submission and assessment of applications for clinical trials for sponsors and regulators. The system includes a public searchable database for healthcare professionals, patients and the general public to deliver the high level of transparency foreseen by the regulation.

The authorisation and oversight of clinical trials is the responsibility of EU / European Economic Area (EEA) Member States while EMA is responsible for maintaining the CTIS. The European Commission oversees the implementation of the CTR.