Improved voluntary harmonization procedure delivers significant benefits for multinational clinical trials in Europe

The new Voluntary Harmonization Procedure (VHP), a voluntary procedure agreed by the Clinical Trials Facilitation Group (CTFG), a working group of the EU Heads of Medicines Agencies, provides a major breakthrough in getting a harmonized regulatory decision on a clinical trial to be performed in more than one European Union member state.

The new version of the VHP guidance (Version 3) represents an important evolution of the VHP process, which was introduced initially as a pilot in 2009 and revised in March 2010. Among the key aspects introduced are:

• A Reference National Competent Authority responsible for the scientific assessment, consolidation of questions and grounds for non-acceptance, and the reassessment of the sponsor's response in collaboration with the National Competent Authorities (NCAs) concerned by the trial and participating in the VHP.
• “Second-wave VHP” of clinical trial applications allowing sponsors to include additional Members States following a positive VHP and taking account of the original assessment.