What is the procedure?
In 2014, new European regulations on drug research were adopted (EU no. 536/2014). These are expected to take effect on 1 January 2022. In the Netherlands, a pilot is being conducted with the new regulations, via the Voluntary Harmonization Procedure (VHP). This is being done in collaboration with the Central Committee on Research involving Human Subjects (CCMO).
The VHP concerns the review of several documents from a research file by several EU countries at the same time, before it is presented to the reviewing committees per country (in the Netherlands: at a MREC for assessment against the WMO). This involves the assessment of the following documents: Protocol, Investigator’s Brochure, and IMPD. The aim is to identify serious deficiencies prior to the official submission that could lead to the rejection of the study. In the Netherlands, a MREC is always involved in a VHP. In total, a VHP takes about 60 days.
What should I submit?
- We request that you inform us in case you plan to register a VHP. There might be a waiting period at the BEBO Foundation, but we will try to align the VHP with the national review. We also ask you to indicate whether the BEBO Foundation will be listed as leading or co-reporter (because of the difference in time investment on our part).
- In addition, you must register the VHP with the Clinical Trials Facilitation Group (CTFG). You can indicate your preference for the BEBO Foundation as the review committee for the Netherlands in the cover letter to the CTFG. You can send the registration to VHP-CTFG@VHP-CTFG.eu.
- For more information and to submit a research file for participation in the VHP, also see the Guidance document of the CTFG (see p. 16).
- In addition, there is information on the website of the CCMO: Voluntary Harmonisation Procedure (VHP).
What should I pay attention to?
At the moment, the VHP submission has no formal status: the VHP is an informal procedure without an official decision. The submitter cannot derive any rights from it, but will receive a (preliminary) review by several EU countries at the same time and can practice using the new method. The official (national) review by the BEBO Foundation will done after the VHP. Then the documents specific to the Netherlands such as the ABR, ICF and insurance will be reviewed.