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  • Regulatory House

Public consultation on the revision of the transparency rules for CTIS

The aim of the review of these rules is to stimulate the discussion on the best possible approaches to balance the transparency of clinical trials with confidentiality requirements (maintaining a high level of personal data protection), while simplifying the ways of using the CTIS in order to reduce the administrative burden for public authorities and sponsors of CTIS.

Following a public consultation, a possible revision of the transparency rules will be submitted to the EMA Management Board for approval and implementation by the end of 2023.

For this reason, interested parties can make their comments via the online form available at this link https://www.ema.europa.eu/en/news/review-transparency-rules-eu-clinical-trials-information-system-ctis until 28 June 2023.

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