FDAnews Drug Daily Bulletin

EMA Postpones Clinical Trials Regulation, Expects Relocation Decision by October

June 21, 2017

The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties.

The EMA plans to modernize its entire clinical trials IT system for the endeavor, in order to provide a single portal for the submission and maintenance of applications. It will also serve as a single point for public information for all clinical trials conducted in the European Union, from first review to results publication. The agency’s management board plans to provide an update, including a new delivery timeframe, at its next meeting, scheduled for this October.

The board also delivered an update on the EMA’s preparations for Brexit, which will be made official March 30, 2019. Primarily, the agency plans to have a final decision by this October on the relocation of its London headquarters to one of the other 27 EU countries.

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