BIA welcomes revised Voluntary Harmonisation Procedure

BIA-logoThe Bio-Industry Association (BIA) has issued a statement welcoming the latest revision of the Voluntary Harmonisation Procedure (VHP), which was issued in April 2013.

Steve Bates, BIA Chief Executive Officer, said: “This voluntary system agreed by national regulatory authorities makes running multinational clinical trials across the EU simpler and cheaper. The BIA has advocated for these changes for a number of years and is delighted that they are making a practical difference to companies. I want to make sure all companies are aware of this procedure and use it – especially if the proposed EU Regulation on clinical trials is delayed for any reason.”

The work-sharing aspects of the latest VHP assessment procedure look very similar to how the clinical trial authorisation procedure is shaping up in the proposed EU Regulation on clinical trials following amendments suggested by the EU Council Working Party. The new version of the VHP guidance introduces:

  • 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.

The latest performance metrics on VHPs (2009 -2012) can be found here.