When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose to go through the Voluntary Harmonization Procedure (VHP) as an alternative to the classical separate Clinical Trial Application to each Competent Authority.
Voluntary Harmonization Procedure in the EU
The VHP was developed by the Clinical Trials Facilitation Group (CTFG) in 2009 to address difficulties in the implementation of the EU directive into national laws and to harmonize the Competent Authority decisions on the clinical trials.
The VHP allows the sponsor to submit a Clinical Trial Application at once to several Competent Authorities in the European Union (at least 2). The main objectives are to ensure a harmonized and consistent assessment of the quality of the IMP and the safety of the trial subjects across the member states. This procedure takes place before the submission of the Clinical Trial Application to each Competent Authority, which is then simplified and shortened.
The VHP is voluntary (from the sponsor’s and from the competent authority’s point of view) and is possible when at least 2 member states are planned.
The VHP decision applies only to Competent Authorities, but some Ethics Committees can also be involved in the review of the core documents.
It is also possible to submit substantial amendments via the VHP.