New law in France for cell and genetic therapies:
This article was originally published in Clinica
New rules have been introduced in France governing clinical trials of cells, cell therapies and genetic therapies. A decree published in the Journal officiel of April 9 demands detailed information concerning the quality of the sourced and finished materials and the microbiological safety review. It also calls for an analysis of the potential risks of the materials (toxicity, carcinogenicity etc) and for detailed information concerning the clinical trial protocol.