Voluntary Harmonization Procedure (VHP)
Voluntary Harmonization Procedure (VHP)
Please note: the Voluntary Harmonization Procedure (VHP) is no longer in use. It was discontinued as the EU Clinical Trials Regulation (CTR, Regulation (EU) No 536/2014) came into application, and has been replaced by the Clinical Trials Information System (CTIS).
The Voluntary Harmonization Procedure (VHP) was an optional route that allowed a sponsor planning a clinical trial in two or more EU member states to obtain a coordinated, harmonized assessment of a single Clinical Trial Application, rather than submitting separately to each Competent Authority. It was developed by the Clinical Trials Facilitation Group (CTFG) in 2009 to address inconsistencies in how individual countries had implemented the EU Clinical Trials Directive into national law.
Under the VHP, the sponsor submitted one application for review by the participating Competent Authorities (at least two). The aim was to ensure a consistent assessment of the quality of the investigational medicinal product (IMP) and the safety of trial subjects across member states. Because this coordinated review took place before the national Clinical Trial Applications were filed, the subsequent national submissions were simplified and shortened.
What replaced the VHP
The VHP was phased out in line with the entry into application of the EU Clinical Trials Regulation (CTR) on 31 January 2022. The final date for VHP submissions was 15 October 2021. Multinational clinical trial applications in the EU are now managed through the Clinical Trials Information System (CTIS), the single portal that supports coordinated assessment and supervision under the CTR. Unlike the VHP, which was voluntary, submission through CTIS is mandatory for clinical trials in the EU. Trials originally authorized under the former Clinical Trials Directive had to transition to the CTR by 31 January 2025.
Sponsors planning or running clinical trials in the EU should now follow the CTR and use CTIS. VCLS supports clients with EU clinical trial strategy and submissions under the current framework.