EU regulation 536/2014 implementation postponed to 2019

As part of the new EU regulation 536/2014, the European Medicines Agency (EMA) has been tasked with creating an EU Portal and Database. The EU Portal will be a single entry point for submission of data and information relating to clinical trials required by the Regulation, including Lay Summaries of clinical trials. This EU Database will contain all data and information submitted via the EU Portal.

The EU Portal and Database will be the backbone of the new framework for clinical trials in Europe. It will facilitate the application for clinical trials authorisation; the assessment carried out by national authorities; and access to clinical trials information by the general public.

The EMA together with EU countries and the Commission are currently working in order to set up the portal and database. On 14 December 2014 the EMA Management Board endorsed the Functional specifications of the EU portal and EU database to be audited.

EMAs Management Board endorsed a timeframe for the delivery of the Portal and Database in December 2015. However, due to technical difficulties with the development of the IT systems, the portal’s go-live date has had to be postponed and therefore the EU Clinical Trial Regulation will come into application during 2019 instead of October 2018, as previously scheduled.

On a positive note, this gives clinical trial sponsors more time to put in place strategies to develop their clinical trial lay summaries!