Search for:

In brief

On 5 October, the European Medicines Agency (EMA) amended its transparency rules on the publication of information on clinical trials submitted through the Clinical Trials Information System. This adjustment was made at the end of the public consultation, launched between May and June, to record stakeholders’ impressions and opinions a few months after European Regulation no. 536/2014 on clinical trials came into effect.

Key takeaways

The new rules, which will come into force after the implementation of the new public portal in the second quarter of 2024, aim to provide access to clinical trial information to stakeholders in a faster and more efficient manner and ensure an increasing balance between data transparency and the protection of business confidential information. One of the most significant changes is the removal of the deferral mechanism, which previously allowed sponsors of clinical trials to postpone the publication of certain data and documents for up to seven years after the end of the trial, in order to protect personal data and confidential business information.


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.


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


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Write A Comment