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Clinical Trials Facilitation Group (CTFG)

Introduction

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

In relation to clincial trials the 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).

CTFG Members and Representatives

The CTFG is composed of representatives from the NCAs, European Commission (EC) and the European Medicines Agency (EMA).

CTFG is currently chaired by Dr. Elke Stahl (BfarM) and Dr. Martyn Ward (MHRA). The secretariat for the group is provided by Kristof Bonnarens (fagg-afmps):

  • Official contact points of the Competent Authorities
    January 2012
    Click here

CTFG Mandate

CTFG's Mandate and Terms of Reference were adopted on the 4 January 2008 by HMA. Click here

The CTFG has the following work-plan ambitions and aims:

  • Sharing of scientific assessment of multi-national clinical trials
  • Harmonising processes, practicies and assessment relating to clinical trials mainly in the fileds of clinical trial applications (CTAs), clinical trial amendments and safety procedures
  • Developing data sharing and participating in improvemnt of information systems
  • Developing communication with stakeholders and co-operating with other EU working groups

CTFG Workplan

  • CTFG Work plan

CTFG Public meetings (Presentations)

  • International CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of Multi-national Clinical Trial Applications, 30 April 2010, Bonn
  • International CTFG Meeting on "Strengthening of worksharing on clinical trials in Europe", 11 June 2010, Paris
  • CTFG Meeting on "Clinical Trials: from European perspectives to National implementation", 19 November 2010, Brussels

CTFG Activity Report

  • CTFG Activity Report 2008 - 2009
    Click here
  • CTFG Activity Report 2010 - 2011
    click here

Clinical Trials Authorisations (CTAs)

  • The Voluntary Harmonised Procedure (VHP)
    • Guidance document for a Volunatary Harmonised Procedure for the assessment of mult-national Clinical Trial Applications, June 2013 click here
    • UPDATE - Results of the Voluntary Harmonisation Procedure (VHP), January 2014 Click here
  • National fees/information
    • Overview of the fees charged by NCAs for submission of different types of clinical trail or amendments, January 2012
      Click here

  • CTA Assessment by NCA and Ethics Committees in Member States, January 2012
    Click here
  • Q and As - Frequently asked questions on CTs
    updated January 2012
    Click here

Clinical Trials Safety

  • DSUR Q and As
    2012
    Click here
  • Reference Safety Information
    2013
    Click here
  • Reference Safety Information : Questions and Answers document
    2013
    click here