Clinical Trials Facilitation and Coordination Group (CTFG)

Introduction/Overview/Mandate

CTFG Introduction/Overview

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).
 

Members and Representatives

CTFG Members and representatives

  • 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)

Contact

CTFG Contact

The secretariat of the group is managed by Italy. The HMA contact is Massimiliano Sarra, PhD, from the Italian Medicines Agency (AIFA).

Contact: m.sarra@aifa.gov.it

Activities and achievements

CTFG Activities and achievements

  • 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

Key documents list

CTFG Key documents list

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

Clinical Trials Authorisations (CTAs)
The Voluntary Harmonised Procedure (VHP)

Guidance

National fees/information

Clinical Trials Safety

 

 

News and events

CTFG News and events

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

 


Save-the-date-information

CTFG Meeting with Stakeholders 28 October 2019
hosted by the Swedish Medical Products Agency, Uppsala, Sweden

Final Program


CTFG will arrange a one-day stakeholder meeting, hosted by the Swedish Medical Products Agency in Uppsala, Sweden.
More information will follow by the end of July.

The aim of the meeting will be to exchange on topics of interest concerning clinical trials, including:

  • Interplay between legislation on in vitro diagnostics (IVDs) and clinical trials
  • Follow-up of CTFG’s Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials  
  • Burning issues and horizon scanning
     

Invitation to the CTFG Meeting with Stakeholders - 28 October 2019, Uppsala

Invitation | pdf

 


CTFG Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials

Please be informed that the Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials has been published on the HMA website under CTFG section "Key document list/Guidance".