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EU Offers More Clarity On Complying With Upcoming Clinical Trials Regulation

 
• By Vibha Sharma

The European Commission has updated its guidance on the technical aspects of the Clinical Trials Regulation to clarify expectations on topics such as expanding authorized trials to additional EU member states and complying with safety reporting requirements.

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EU Clinical Trials Regulation Is Expected To Apply From Dec 2021 • Source: Shutterstock

The European Commission has updated its draft Q&A guideline on the EU Clinical Trials Regulation to clarify a range of issues, such as documentation and processes to be addressed in cases when a sponsor requests to extend an authorized clinical trial to another EU member state.

The draft guideline, which includes Q&As discussed progressively since December 2014, aims to support the implementation of the CTR (No 536/2014) by addressing frequently asked questions on technical aspects of...

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