EU Clinical Trial Sponsors Reassured On Member State Dossier Requirements

 
• By Vibha Sharma

The European Commission wants to ensure that the content of dossiers filed under the EU Clinical Trial Regulation is harmonized to simplify the trial approval process. Any national requirements imposed by member states should have a clear legal basis. 

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The responsibility to evaluate, authorize and supervise clinical trials rests with the EU Member States and European Economic Area countries. • Source: Shutterstock

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