The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.
The assessment is conducted and coordinated between the national competent authorities (medicines agencies) of the countries in which the trial is to take place following which the application is submitted to the countries involved. It is an offer through which sponsors can obtain a harmonised assessment of an application. The actual trial must still be authorised at national level, and it is therefore not a centralised authorisation. Provided that the VHP assessment reaches consensus, 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.
In March 2010, version 2 of the VHP guidance document was released
The changes refer to:
- Changed inclusion criteria: All trials in which at least three EU countries participate may be assessed in this coordinated procedure,
- Deletion of the ”Pre-procedural step” or “Request for VHP” phase in the procedure,
- Amendments to trials having undergone a VHP can also be submitted under the coordinated procedure.
Please find the updated VHP guidance document in the factbox to the right.
The VHP has been developed and launched by the Clinical Trial Facilitating Group (CTFG). The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements. The VHP was launched as a pilot project in February 2009. Link to CTFG: http://www.hma.eu/77.html
Applications for assessment under the VHP should be submitted to the VHP secretariat. You can read more about the procedure in the factbox to the right.
Danish Medicines Agency, last updated 23 April 2010