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Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

 
• By Vibha Sharma

Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.

Belgium’s Federal Agency for Medicines and Health Products is preparing to launch a pilot later this year under which it plans to review clinical trial applications in parallel with national ethics committees and within the strict timeframes specified in the upcoming EU Clinical Trials Regulation.

The FAMHP explained that while the voluntary pilot would be conducted under Belgium’s current national clinical trials legislation of May 7, 2004, the evaluation of clinical trial dossiers included in the pilot “would follow the spirit” of the CTR that is set to come into force in October 2018

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