EMA board confirms the EU clinical trial portal and database is fit for purpose

The European Medicines Agency (EMA)’s Management Board has announced that the clinical trial EU portal and database is now fully functional and on track to go live by 31 January 2022. This was confirmed during an extraordinary meeting held on 21 April, following an independent audit of the new system.

The portal and database are one of the main deliverables of the 2014 Clinical Trial Regulation (Regulation (EU) No 536/2014), which was enforced to harmonise the assessment and supervision processes for clinical trials throughout the EU. This is supposed to be achieved using a Clinical Trials Information System (CTIS), which will contain the centralised EU portal and database for clinical trials.

“The findings from the audit have reassured the Management Board that the EU Portal and Database now meet the functional specifications drawn up by EMA in collaboration with the European Commission and the Member States. We are all prepared to start working with the system,” said Christa Wirthumer-Hoche, chair of EMA’s Management Board. “The implementation of the Clinical Trial Regulation and CTIS will increase efficiency in the registration, conduct and supervision of clinical trials in the EU, particularly those taking place in multiple Member States, while ensuring utmost transparency for the public. This is one of the most complex and ambitious IT developments carried out by EMA and we look forward to its go-live in early 2022.”

“The EU is an attractive location for investment in clinical research and this development will further enhance its value as a large and dynamic clinical research area, enabling authorities and researchers to cooperate more effectively across Member States,” added Xavier De Cuyper, Director of the Belgian medicines agency, speaking for the Heads of Medicines Agencies clinical trial network. “It also means we can further enhance the benefits for our citizens of new medicines, and better use of existing medicines, and provide them with access to increased public information on clinical trials as they are ongoing and their results when the trials are completed.”

The board will now inform the European Commission (EC) of its conclusion and, once the EC is satisfied the conditions set by the regulation have been met, it will publish a notice in the Official Journal of the European Union and six months after this publication, the Clinical Trial Regulation will start to apply and CTIS will go live. To meet the 31 January 2022 deadline, the notice would need to be published by the end of July 2021.