One of the features of the EU Clinical Trials Regulation No 536/2014 (external link) is the creation of the EU portal and the EU database for clinical trials. The Regulation and systems infrastructure provided by the portal and database are intended to simplify and harmonise the submission, assessment and reporting of clinical trials. As a result, this systems infrastructure will be used by everyone who is affected by application of the Regulation including applicants for the clinical trial, Member States and members of the public.
The EU Clinical Trials Regulation will only apply after an audit of the EU portal and the EU database has shown these systems are fully functional. This audit will be based on the agreed functional specifications.
The European Medicines Agency (EMA) has prepared a draft of these functional specifications in collaboration with the Member States and the European Commission.
The EMA have launched a public consultation on this draft functional specification (external link). Stakeholders are invited to review the document and provide comments to the EMA by 31 October 2014.
EU Clinical Trials Regulation No 536/2014 (external link)