• Regulatory House

Six-month countdown to go-live for the Clinical Trials Information System (CTIS)

EMA and SÚKL has informed on their website that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022. On this day, regulation No. 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use will also enter into force. At the same time, from 31 January 2022 the so-called transitional period will start.

From 31 January 2025, all clinical trials will be authorized and will take place exclusively in accordance with Regulation No. 536/2014.