Clinical Trial Regulation expected to apply from January 31, 2022
The European Medicines Agency (EMA) has announced a new expected go-live date of the Clinical Trials Information System (CTIS): 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.
So far, the go-live date for CTIS has been postponed several times. When the European Commission has determined the final go-live date, this decision will be published in the Official Journal of the European Union. Six months later 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.