Public consultation on how the transparency rules of the EU Clinical Trial Regulation (no. 536/2014) (“Regulation”) are to be applied in the new database for clinical trial information has been launched by the European Medicines Agency. Participants have until Wednesday 18 February 2015 to comment.
The Regulation is intended to apply from May 2016 and aims to ensure consistency in the approach to clinical trials throughout the EU. The aim is for there to be more transparency on authorisation, conduct and results which will in turn change the level of publically available information. The database will be an important tool for clinical trial applicants.
The consultation is available on the EMA website at www.ema.europa.eu/ema.