TranslateUpdate on the EU Clinical Trials Regulation (EU) No 536/2014
Date: 25 January 2016
The application of the forthcoming EU Clinical Trials Regulation is linked to the full functionality of the EU portal and database under development by the European Medicines Agency (EMA).
In the EMA meeting in December 2015, the EMA Management Board provided an update on the development of the clinical trial portal and database.
The Board foresees that the database and portal will be available for independent audit by August 2017.
If the portal and database get a green light from the audit, the Regulation will come into effect by October 2018 at the latest.
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- Summary:The application of the forthcoming EU Clinical Trials Regulation is linked to the full functionality of the EU portal and database under development by the European Medicines Agency.