The European Medicines Agency (EMA) had revised its transparency rules for the Clinical Trials Information System (CTIS) and was effective from October 2023. These changes aim to simplify processes, enhance transparency, and protect sensitive information, benefiting patients and clinical researchers across the EU. Initially launched in January 2022 under the Clinical Trials Regulation (EU) No 536/2014, CTIS faced challenges due to the complexity of its deferral mechanism. Feedback from stakeholders highlighted the need for clearer publication rules and improved user experience. The revised rules focus on publishing structured data fields and key documents earlier, simplifying the deferral mechanism, and maintaining high levels of data protection. The implementation of these changes is expected to improve user experience, enhance public access to clinical trial information, and reduce administrative burdens for sponsors.
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