Update on the new Clinical Trial Regulation pilot project

date: 01/03/2019

The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium, with the introduction of a new option for sponsors willing to participate : the VHP plus.

Since 2017, the FAMHP has started a pilot project for clinical trials in Belgium in collaboration with the new college charged with the designation of the ethics committee for the evaluation of clinical trials, the current ethics committees and the sponsors of clinical trials.

FAMHP experts and the college have developed a guidance document to assist sponsors in this process. In this guidance document you will find, among others, the timelines for the procedures in the pilot project and the list of documents to be submitted.

This guidance document is adapted as the pilot project progresses: here is the version 6.0 of the guidance document for clinical trials sponsors which replaces the previous versions and is directly applicable.

An addendum to this main guidance, specifically related to the pilot process VHP plus, is also published today. This is version 1.0 of the VHP plus addendum.

If you wish to participate in this pilot project, please fill in the form and send it to CTRpilot@fagg-afmps.be.

More information
Call for action the participate in pilot projects


Last updated on 01/03/2019