Clinical Trial Facilitation Group (CTFG)
In 2004 the Heads of Medicines Agencies (HMA) agreed 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.
The CTFG consists of clinical trials professionals from the EU/EEA Medicines Agencies (NCAs). In relation to clinical 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).
Activities and achievements
- 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
Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications
The Voluntary Harmonisation Procedure (VHP) was developed and launched by the Clinical Trial Facilitating Group (CTFG).
With the procedure it is possible to obtain a coordinated assessment of an application for a clinical trial that is to be conducted in several European countries. At the beginning the procedure was voluntary for national competent authorities/medicines agencies, but since December 2014 the participation is mandatory.
The application for a clinical trial is sent to the VHP coordinator, naming the countries in which the trial is going to be conducted. The assessment is conducted and coordinated between the national competent authorities of the concerned countries. I.e. one medicines agency acts as Reference national competent authority the others as Participating national competence authority. After an approval via VHP the trial must still be authorised at national level, it is not a centralised authorisation. The scientific content of the application must not be changed when submitted to the national competent authorities. However, it may be adapted to meet national requirements.
Which documents are to be submitted under a national VHP?
When a clinical trial has been approved via VHP the application must be submitted to IMA for authorisation within 20 days.
IMA must issue a decision within 10 days of valid application. A confirmation that documents submitted are the same as approved in VHP procedure needs to be submitted with the application.