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CTIS: EMA Consults On Transparency Rules & Simplifications For Clinical Trials Portal

 
• By Neena Brizmohun

The European Medicines Agency says that any changes it makes to its transparency rules on the information that is submitted through the Clinical Trials Information System will be implemented before the end of 2023.

Young businessman thinks over the steps for successful growth: Clinical trial
The Clinical Trials Regulation ushered in strict transparency requirements • Source: Shutterstock

The European Medicines Agency is seeking feedback on the best possible approaches it can use to balance clinical trial transparency with confidentiality requirements in the publication of information that is submitted through the EU’s Clinical Trials Information System (CTIS).

Specifically, the agency wants to learn how to achieve this balance “while simplifying the modalities of use of CTIS to improve user experience and reduce the risk of data breaches.”

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