Pilot project for new Clinical Trial Regulation

date: 11/01/2017

In October 2018 the new clinical trial regulation 536/2014 (CTR) is foreseen to enter into force. This important change in legislation targets administrative simplification and harmonization in Europe.

An important, preparatory step is a pilot project to obtain experience and align processes between all participants.  The CTR pilot is organised in collaboration with the ethics committees. The procedure to authorise the trial will follow the national legislation of 7th May 2004 but the dossier to be sent and its evaluation will follow the spirit of the new regulation and the draft Belgian law.

Sponsors of trials are invited to express their intent to become a candidate for the pilot. Sponsors are helping famhp to recognize obstacles and to streamline the procedure and will off course obtain useful experience prior to the entering in force of the new regulation. If you are willing to express your intent please fill out this form and send it to CT.RD@fagg-afmps.be. Beginning of February the sponsors will be contacted to plan further steps based upon available resources.

More information


Last updated on 11/01/2017