Clinical Trial Regulation (CTR) applicable from 31 January 2022, VHP concludes on 15 October 2021

On 31 July, the European Commission has announced in the Official Journal of the European Union that the Clinical Trial Information System (CTIS) meets the requirements as stipulated in the CTR. This means that the European Regulation 536/2014 will definitely be applicable from 31 January 2022. Also, CTIS will go live  on this date.. Once the CTR is applicable, a transition period of three years applies. During the first year, the sponsor may choose to submit the study and have it assessed according to the current legislation or according to the CTR via CTIS.

The publication of this decision also means that the Voluntary Harmonisation Procedure (VHP) in Europe will come to an end. 15 October 2021 is the last day on which VHP submissions will be accepted. For more information, please consult the website of the Clinical Trials Facilitation and Coordination Group.

A training programme for CTIS  is available on the EMA website. A sponsor handbook is available to help clinical trial sponsors prepare for using CTIS.