The Belgian Federal Agency for medicines and health products (FAMHP) and the Federal Agency for public health are seeking comments to a public consultation on a clinical trial involving talimogene laherparepvec, a genetically modified medicine. The medicine, produced by Amgen, is used treat hepatocellular carcinoma or metastatic liver tumours, and the clinical trial has been designed to evaluate its safety after it has been injected into a liver tumour. The clinical trial will take place in various hospitals throughout the country.
The website of the Federal Agency for public health contains additional information on talimogene laherparepvec and the specific clinical trial including, amongst other things, the technical file and safety related information.
The consultation closes on 7 December 2016.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, November 2016 Issue (Thomson Reuters).