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EMA to review CTIS transparency rules

EMA to review CTIS transparency rules

Public consultation seeks the best methods for balancing transparency with confidentiality in the EU Clinical Trials Information System, says the European Medicines Agency.

The European Medicines Agency (EMA) has opened a public consultation to review the transparency rules for information submitted through the EU Clinical Trials Information System (CTIS).

The review aims to generate discussion on the best approaches to balance clinical trial transparency with confidentiality requirements. At the same time, the EMA’s objective is to simplifying the modalities of use of CTIS to improve user experience and reduce the risk of data breaches.

Changes to CTIS transparency rules

Any changes in the CTIS functionalities that might follow post-consultation will maintain the high benchmark for transparency provided by the Clinical Trials Regulation (CTR), the regulator noted.

Simplification of the rules is meant to reduce the burden of administration for CTIS public authorities and sponsors. However, they will not lower protection of personal data and commercially confidential information.

The EMA stated that interim guidance on the protection of personal data and commercially confidential information while using the current transparency rules for CTIS has been modified. 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.

Benefits of the Clinical Trials Regulation 

According to the EMA, 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. This is 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 to deliver the high level of transparency foreseen by the regulation.

Stakeholders are invited to send their comments on the CTIS transparency rules by midnight (CET) on 28 June 2023.

Any proposed revision to the transparency rules Clinical Trials Information System will be presented to EMA’s Management Board for approval. Implementation is expected before the end of 2023.

5 May 2023


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