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In brief

New transparency rules related to the Clinical Trials Information System (CTIS), adopted by the Management Board of the European Medicines Agency (EMA) in October 2023, became applicable on 18 June 2024.


Key takeaways

These rules aim at striking a balance between transparency and the protection of commercially confidential information for the benefit of patients, who will have early access to key clinical trial information, of healthcare professionals, who will enjoy simplification in accessing to trial information and enrollment, and of trial sponsors, who will interface with a more user-friendly system.

Among the various changes made to the aforementioned rules, it is to underline the removal of the deferral mechanism, which previously allowed clinical trial sponsors to delay the publication of certain data and documents for up to seven years, starting from the end of the trial, in order to protect personal data and commercially confidential information.

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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