The Heads of Medicines Agencies (HMA) agreed in 2004 to establish a clinical trials facilitation group (CTFG) to coordinate the implementation of the EU clinical trials directive 2001/20 EC across the member states.

In relation to clincial trials, the Clinical Trials Facilitation and Coordination Group (CTFG) acts as a forum for discussion to agree on common principles and processes to be applied throughout the European medicines regulatory network (EMRN). It also promotes harmonisation of clinical trial assessment decisions and administrative processes across the national competent authorities (NCAs).
 

• Representatives from the national competent authorities for the authorisation of clinical trials on human subjects, the European Commission and the European Medicines Agency
• Representatives from other interested parties may be invited to attend the CTFG meetings on an ad hoc basis if deemed valuable and consensual and in agreement with the HMA rules on
  observers
• The Chair is elected amongst the members for a period of two years
• Currently chaired jointly by two Co-chairs: Elke Stahl, Ph.D (BfArM, Germany) and Ann Marie Janson Lang, MD, Ph.D (Swedish MPA, Sweden)
• The mentor of the group at the level of HMA is Xavier De Cuyper (FAMHP, Belgium)

The secretariat of the group is managed by Italy. The HMA contact is Giovanni Affronti from the Italian Medicines Agency (AIFA).

Contact: ctfg.secretariatnoSpam@noSpamaifa.govnoSpam.it

• Stakeholder information: HMA VHP for clinical trials - 1000th procedure
• Publication of updated Q&A documents e.g. on follow-up of patients after clinical trials, DSUR reporting.
• Enlargement of the Voluntary Harmonisation Procedure in the number of initial applications, substantial amendments and distribution of Sponsors (worldwide: EU;USA, Canada, Australia, Singapore).
• Liaising between the EMA, CHMP and CTFG on specific topics where the decision on a marketing authorisation has an impact on clinical trials in Europe.
• Continuation of work sharing e.g. DSUR, exchange of opinions or assessment on critical topics/ national Clinical Trial Applications.
• Supporting and analysing the new Clinical Trials Regulation

Brexit

UK/EU transition period will end on December 31 2020.

Technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials following the withdrawal of the United Kingdom from the EU | pdf

CTFG Activity Report

• CTFG Activity Report 2008 - 2009 | pdf
• CTFG Activity Report 2010 - 2011 | pdf

Clinical Trials Authorisations (CTAs)

• Conclusion of the Voluntary Harmonization Procedure project, July 2021 | pdf
• VHP - Brexit and Christmas Break, October 2020 | pdf
• Results of the Voluntary Harmonisation Procedure 2009 - 2020, February 2021 | pdf
• VHP procedures in preparation and in case of a no-deal Brexit | pdf
• European Union Member States national pilot projects in support of the transition to the new Clinical Trial Regulation EU 536/2014, October 2020 | pdf
• European Union Member States participation in VHP and VHP-related activities, October 2020 | pdf
• Guidance document for sponsors for a Voluntary Harmonised Procedure for the assessment of multinational Clinical Trial Applications, Version 5, October 2020 | pdf

Guidance

• Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic | pdf
  Update of the guidance 28 April 2020 available here
• Link to National guidance on CT management during the COVID-19 pandemia | pdf
  Updated on 31 March 2020
• Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials | pdf
• Best Practice Guide for sponsors of transition multinational clinical trials | pdf
• Q and As on GLP, March 2017 | pdf
• Recommendations related to contraception and pregnancy testing in clinical trials, version 1.1 | pdf
  Update to document has been adopted and implemented on 21/09/2020
  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.

National fees/information

• Overview of the fees charged by NCAs for submission of different types of clinical trial or amendments, January 2012| pdf
• Q and As - Frequently asked questions on CTs, updated January 2012| pdf

Clinical Trials Safety

• DSUR Q and As, 2012| pdf
• Q&A document – Reference Safety Information, November 2017| pdf
• Covering Note - Q&A Reference Safety Information, March 2018 | pdf

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