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Italy: European Medicines Agency public consultation to review the Clinical Trials Information System transparency rules

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In brief

On 3 May 2023, the European Medicines Agency (EMA) launched a public consultation in order to review the rules on the publication of clinical trial information submitted through the Clinical Trials Information System (CTIS). The CTIS is the dedicated web portal for the submission of authorizations relating to clinical trials and their management in Europe, aimed at streamlining clinical trial applications and the supervision of clinical trials pursuant to forth in Regulation (EU) 536/2014.

Key takeaways

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.

Following the public consultation, which will end on 28 June 2023, any revision to the transparency rules will be presented to EMA’s Management Board for approval and implementation before the end of 2023.

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Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Author

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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