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EU Explains How Info Requests Will Be Managed Under Clinical Trials Regulation

Only One Consolidated Request Is Likely

 
• By Vibha Sharma

Updated guidance on the upcoming EU Clinical Trials Regulation deals with requests for information from the regulators and how strict timelines for evaluating clinical trial applications will be adhered to. 

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Guidance On EU Clinical Trials Regulation Has Been Revised • Source: Shutterstock

The European Commission has revised its draft questions & answers document on the EU Clinical Trials Regulation to clarify, among other things, that sponsors would likely receive only one consolidated request for information (RFI) from the member states if there are outstanding concerns about their clinical trial-related applications.

This is designed to help ensure that all stakeholders can comply with the strict evaluation timelines specified in the CTR for the assessment of initial clinical trial applications, applications for...

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