Clinical Trials Facilitation Groups
The meeting saw the participation, including AIFA, of the following Member States' Medicine Agencies: Austria, Belgium, Bulgaria, Denmark, Finland, France, Germany, Ireland, Latvia, Norway, Poland, Portugal, Romania, Sweden, Spain, and United Kingdom. The CTFG has been instituted in 2004 by the Heads of Medicines Agencies (HMA) in to coordinate the implementation of the clinical trials European Directive 2001/20 across the Member States.
Within the working group's mandate, among others activities, of a particular importance is to harmonize the procedures and decisions relevant to clinical trials and to share scientific assessment. The group particularly discussed the following topics: Legislation revision proposals on clinical trials and guidelines development Voluntary harmonized and coordinated procedure for the trials approval by the European Competent Authorities (Voluntary Harmonized Procedure VHP) Coordination and optimisation of resources during the authorization process, the safety monitoring and GCP-inspection activities IT system development (EudraCT, EU ClinicalTrial Register) Working plan for the next 2 years focused on the preparation of the revision of the clinical trials European.
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