October 2021: Voluntary Harmonisation Procedure Update

Update from Heads of Medicines Agencies (HMA) on the Conclusion of Voluntary Harmonisation Procedure (VHP)

The full implementation of the new Clinical Trials Regulation 536/2014 is planned for January 31, 2022. Therefore, all voluntary harmonisation procedures (VHP) are planned to be finalized in January 2022. In order to organize a smooth transition of the VHP processes into CTIS and the CTR, the last day for any VHP submission is October 15, 2021. Submission after the deadline (15 October midnight) will not be accepted without further notice (neither initial application, nor substantial amendment nor addition of Member State).

VHP is voluntary and applies to multi-national clinical trials conducted in the EU. It allows the sponsor to submit a single clinical trial application at once to 2 or more national competent authorities in the EU. The Heads of Medicines Agencies (HMA) is a network of the heads of the national competent authorities, the agencies responsible for the regulation of human and veterinary medicines in the individual countries of the European Economic Area (EEA). Additional information can be found here.