Gene therapy product quality aspects in the production of vectors and genetically modified somatic cells - Scientific guideline

This document provides quality recommendation for gene therapy products derived by biotechnology/high technology and intended for human use. It aims to facilitate the collection and submission of data to support applications for marketing authorisation.

Keywords: Recominant, DNA, rDNA, somatic cells, vectors

Current effective version

Gene therapy product quality aspects In the production of vectors and genetically modified somatic cells

Adopted Reference Number: 3ab6a Legal effective date: 01/07/1995