February 3, 2015
The European Clinical Trial Regulation aims to ensure consistency in conducting clinical trials throughout the EU as well as bring a great amount of transparency to the clinical trial process by making information publicly available. The Regulation will apply to clinical trials that are registered once the Regulation is in operation. A public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database is launched by the European Medicines Agency (EMA) today. Stakeholders are invited to send their comments before 18 February 2015. This document asks stakeholders to review and comment on the proposals laid out by the EMA to bring expanded transparency to the clinical trial process in the EU.
Stakeholders are invited to send comments using this template to CTReg@ema.europa.eu by close of business on 18 February 2015.