On 19 December 2019, the Belgian Federal Agency for Medicines and Health Products (FAMHP) issued updated guidance for clinical trials sponsors. This document (and each of its previous versions) was adopted in the context of a pilot project that aims to prescribe the procedures and rules for the collaboration between the FAMHP, the Belgian Clinical Trial College and Ethics Committees (as defined under Article 2 of the Clinical Trials Regulation ((EU) 536/2014)) in preparation for the Regulation becoming applicable. New elements included in the updated guidance concern, among other things, the deadlines for the different procedures under the pilot project and the modalities for sponsors to file documents.
This article was co-authored by Claire Caillol.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2020 Issue (Thomson Reuters).