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 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
- 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 (MPA, Sweden)
- The mentor of the group at the level of HMA is Xavier De Cuyper (FAMHP, Belgium)
The secretariat of the group is shared by Ireland and Italy. The HMA contact is Massimiliano Sarra, PhD, from the Italian Medicine Agency (AIFA)
- 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
Clinical Trials Authorisations (CTAs)
The Voluntary Harmonised Procedure (VHP)
- Guidance document for a Voluntary Harmonised Procedure for the assessment of multinational Clinical Trial Applications, June 2016 | pdf
- VHP-plus: List of Participating National Competent Authorities, January 2018 | pdf
- List of participating member states in VHP, January 2017 | pdf
- Results of the Voluntary Harmonisation Procedure 2009 - 2017 | pdf
- VHP metrics note, 2015 - 2017 | pdf
- Best Practice Guide for sponsors of transition multinational clinical trials | pdf
- Recommendations related to contraception and pregnancy testing in clinical trials, September 2014 | pdf
- Q and As on GLP, March 2017 | pdf
- 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