FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Testing of EMA’s New Clinical Trials Database Continues

Dec. 20, 2017

The European Medicines Agency is making progress toward its new portal and database of clinical trials information. A partially-completed version has undergone testing by representatives of the European Commission, member states, academia, industry and contract research organization associations over November, while technical testing and additional development continues.

A more-final version, delivering end-to-end processes, is moving forward and will be presented for a new round of testing, with a final audit planned for next year, the EMA said. After the audit is completed, timelines will be set for launch. The EMA called the IT endeavor its most ambitious pharmaceutical project so far.

The EMA postponed the implementation of its Clinical Trials Regulation earlier this summer, pushing it back from October 2018 to 2019 at the earliest, following technical difficulties. The web portal will serve as a single point for public information for all clinical trials conducted in the European Union, from first review to results publication.

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