The Netherlands to expand VHP participation from January 2017

From January 2017, the Netherlands will be expanding its participation in the Voluntary Harmonisation Procedure (VHP), in anticipation of the upcoming EU Clinical Trials Regulation 536/204. Apart from the CCMO, the following twelve METCs will be participating in the VHP: the eight MRECs linked to university medical centres in the Netherlands, the MREC of the BEBO foundation, the MEC-U, the AVL MREC, and the MREC Brabant.

The VHP assessment will also be used for a pilot in order to allow the testing committee to gain experience with an assessment that is largely governed by the EU Regulation. In light of this development, the participating testing committees will discuss their assessments with one another during the pilot stage. The experience gained during the pilot will be used to optimise the new working procedure for testing drug trials.