European Union “Clinical Trials Regulation” concerned with establishing a harmonised application dossier and common authorisation process for clinical trials performed within the EU. EU 536/2014 requires transparent reporting of clinical trial results (including a summary for lay persons) – with mandatory publication via the EU Portal and EU Database – a publicly available, free-of-charge site, conforming to the international clinical trials registry platform of the World Health Organization (WHO ICTRP). The process of trial authorisation is defined by EU 536/2014 to be the responsibility of a single EU Member State – the “Reporting Member State”. The Regulation, which was signed on 16th April 2014 and entered into force on 16th July 2014, will come into full effect from 28th May 2016.
Menu