Following the April 2017 adoption of the new Belgian law on clinical trials with medicines for human use, which implements the new Clinical Trial Regulation (Regulation (EU) No 536/2014), and a first call for applicants for a pilot project in January 2017, the Federal Agency for Medicines and Health Products (FAMHP) has now adopted guidelines for the pilot (see previous update Belgium adopts law to prepare for Clinical Trials Regulation implementation). The guidelines, which will be adapted as the pilot progresses, include timelines for the procedures in the pilot and an update of the documents that need to be submitted. In addition, the FAMHP announced that a second wave of pilot projects will start in September 2017 inviting sponsors of clinical trials to participate.

The pilot is in accordance with the Law of 7 May 2004 on experiments on humans, but follows the spirit of the Clinical Trial Regulation and the newly adopted Belgian law. The selection of the Ethics Committee (EC) will be made by the college to be established in accordance with the new law on clinical trials, and the joint assessment (by the national contact point and the EC) will be conducted with the use of new European templates.

The purpose of the pilot is to: (i) develop processes and procedures for the joint assessment of clinical trial applications and for the compilation of an assessment report; (ii) evaluate such processes and procedures; and (iii) adjust them accordingly. It gives the FAMHP, the future College and the ECs a chance to test the short timelines for Phase I mono-national trials within the framework of the Clinical Trial Regulation. For sponsors, on the other hand, the participation in the pilot provides an opportunity of adjusting and testing their own processes with regard to the timelines and procedures of the Clinical Trial Regulation.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2017 Issue (Thomson Reuters).