Update on the new Clinical Trial Regulation pilot

date: 08/05/2017

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


FAMHP experts have written a guidance document to assist in this process. In this guidance document you can find amongst other things the timelines for the procedures in the pilot and an update on the documents to be submitted. An empty submission dossier is also available.

This guidance document will be adapted as the pilot progresses.


The FAMPH invites sponsors of clinical trials to express their intent to be involved in the second wave of pilot projects that will start in September 2017.


To express your intent, please fill out this form and send it to CTRpilot@fagg-afmps.be


More information:

Pilot projects for the new Clinical Trial Regulation


Last updated on 08/05/2017