Clinical Trial Regulation to apply from January 31, 2022

The European Medicines Agency (EMA) has confirmed that the development of the Clinical Trials Information System (CTIS) is on track to go live on January 31, 2022. From that moment on, the European Clinical Trial Regulation (CTR) will apply as well.

CTIS is being built for the implementation of the CTR (EU no 536/2014) and will be the central portal for the submission and review of research with a medicinal product in the European Union.

As a next step the European Commission will announce in the Official Journal of the European Union, no later than July 31, 2021, that CTIS meets the conditions set by the CTR. Six months later, on January 31, 2022, CTIS will go live and the CTR will apply.

Once the CTR is applicable, a transitional period of three years will come into effect. During the first year of this period, the sponsor can still choose to either submit and have research with a medicinal product reviewed according to the current legislation, or according to the CTR through CTIS.

A training programme for CTIS is available on EMA’s website.