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Navigating The EU's Revised Clinical Trial Disclosure Rules

Interim Measures Provide Options For Early Adoption Of The Updated Requirements

 
• By Vibha Sharma

The European Medicines Agency is preparing to roll out simplified transparency rules for its Clinical Trials Information System in mid-2024. This article looks at what will change and the impact on the thousands of trials that are already in the system.

Glasses View
Instead of publishing almost the entire clinical trial dossier, the revised transparency rules focus on data and documents of key interest • Source: Shutterstock

Nearly two years after a new portal was launched for submitting EU clinical trial applications to support the implementation of the Clinical Trials Regulation (CTR), the focus is now on simplifying compliance with one of the most complex aspects of the legislation – its transparency provisions.

New simplified transparency requirements for the Clinical Trials Information System (CTIS) portal were agreed in October 2023, but these will not be formally rolled out in the system until the second or third quarter of 2024

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