Important change on the EU clinical trial market is expected by 31 January 2022 – updated EU Clinical Trial Regulations will come into effect.

According to the European Commission, the EU portal and the EU database fulfilled the conditions of full functionality, and the systems meet the required functional specifications to build up the unique Clinical Trials Information System (CTIS).

The CTIS will be the single-entry point for submission, authorisation and supervision of the clinical trials in the EU, and in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway – up to 30 countries in total, which is a huge step towards harmonisation of the country-specific rules and regulations.

Among other advantages, CTIS will allow Sponsors and CROs to easily expand trials to other EEA countries and facilitate cross-border collaboration and knowledge sharing.

However, CTIS will not be the system designed only for Sponsors and medical specialists – it will have a public website where anyone can find the information on all the clinical trials (including their outcomes) conducted in the EU. Thus, the system will contribute to transparency and easier access to information not only to the specialists involved, but also to the patients and other interested parties, so basically to everyone.

For Sponsors and CROs to get used to CTIS and probably to mitigate teething troubles of the system, a 3-year transition period is offered. EMA also created an extensive training program for Sponsors, local regulatory authorities, and ethics committees.

Sounds huge and very promising, so hopefully this will contribute to serious reduction and increased predictability of trial start-up timelines, improvement of data quality and overall harmonisation of country-specific requirements.