Clinical Trials: Application of the CTR confirmed as of 31 January 2022

It is now officially confirmed: On 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) will become applicable. This means some significant changes for clinical trials in Europe with regard to the processes and procedures for authorizing, conducting and terminating clinical trials. 

What GMP / GCP changes are coming in connection with the CTR?

On 31 July 2021, the EU Commission confirmed the full functionality of the CTIS (Clinical Trials Information System) by decision in the Official Journal of the EU. This means that six months remain until the Clinical Trials Regulation (CTR) EU 536/2014 will come into application. This will be followed by a consecutive transition period of three years, during which both the contents of the CTR and the current legislation on clinical trials will apply.

The EU Commission has also published several documents, whose applicability is also linked to the first-time application of the CTR, including:

Draft documents of the EMA in connection with the CTR

Current draft documents from the European Medicines Agency (EMA) related to the CTR include:

The EU Commission’s Decision (EU) 2021/1240 can be found in the Official Journal of the European Union dated 31 July 2021.