Update Clinical Trial Regulation: new delivery date EU portal and EU database
The Board of the European Medicine Agence (EMA) has published a delivery time frame for the EU portal and EU database.
The timeframe endorsed by the Board enables the robust development and testing of the system and allows resolving unforeseen difficulties and potential issues.
The timeframe foresees that the database and portal are available for independent audit by August 2017.
If the system gets a green light from the audit, the EU Clinical Trial Regulation (EU nr 536/2014) will come into effect by October 2018 at the latest.
See for more information the EMA website.