CTFG News and events

19/07/2021

Conclusion of VHP Procedure
Deadline for submissions to VHP in the context of the Christmas Break 2021/2022 and transition to CTIS/CTR starting with the CTR application

The CTFG informs the Sponsors that the full implementation of the CTR 536/2014 is planned for the 31 January 2022. In order to organise a smooth transition of the VHP-Processes into CTIS and the CTR, especially in the light of the VHP-Christmas break the following deadlines were defined.   
The VHP Christmas break 2021/2022 will take place between 22 December 2021 and 7 January 2022 (including). All VHPs procedures should be finalised in January 2022. In order to achieve this goal and to offer clear guidance the last day for any VHP submission (initial, substantial amendment, 2nd round) will be 15 October 2021.

Additional details are available here.

21/01/2021

Conclusion of the Voluntary Harmonization Procedure project

The CTFG informs the Sponsors that the Voluntary Harmonization Procedure (VHP) project will be closed contextually with the implementation of the EU regulation 536/2014 on clinical trials. Sponsors are therefore informed that, starting 60 days before the effective date of the new regulation, initial clinical trial applications and substantial modifications applications via VHP will no longer be accepted and processed by the VHP administrator.

9/10/2020

Press release relating to the organisation of the CTFG meeting with Stakeholders

The CTFG would like to inform stakeholders that due to the health emergency situation related to Covid-19 and the subsequent measures taken by  countries, the meeting, initially scheduled for the fourth quarter of 2020, will instead now be held in the second half of 2021. The CTFG believes that the real value of meetings with stakeholders is the possibility of exchange between people and therefore the CTFG have chosen to postpone the meeting rather than organise a virtual one, in order to encourage the interaction between stakeholders who belong to the world of clinical trials. However, exchange with stakeholders is of importance for the CTFG, thus we plan to have a virtual meeting in 2021 if a face to face meeting will not be possible.

21/09/2020

An update has been adopted and implemented to CTFG document “Recommendation related to contraception and pregnancy testing in clinical trials“.

The changes are as follows:

• after the relevant systemic exposure to the medicinal product has ended for exposure to other types of genotoxicants than aneugenic compounds, the duration for applying highly effective contraception measures for women of childbearing potential, has been extended from 1 month to 6 months (one folliculogenesis cycle).
• the need for informing participants to seek advice about donation and cryopreservation of germ cells in line with this guidance prior treatment if applicable, has been added to the section on the need for sexual counseling of study subjects, e.g. in adolescents, which should be reflected in the protocol.
   

Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

Update of the guidance 28 April 2020 available here