EMA issues revised transparency rules for the EU clinical trials information system

6 October 2023

The European Medicines Agency (EMA) today revealed it has adopted r evised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS).

The EMA noted that the simplifications introduced will give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way.

One of the key changes of the revised rules is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect personal data and commercially confidential information (CCI).

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