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 shared by Ireland and Italy. The HMA contact is Massimiliano Sarra, PhD, from the Italian Medicine 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

News and events

CTFG News and events

Save-the-date-information

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

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

 

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".