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

Current effective version

PDF iconAdopted guideline

Reference number 3AB6A
Published 31/12/1994
Effective from 01/07/1995
Keywords Recominant, DNA, rDNA, somatic cells, vectors
Description 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.

Related content

How useful was this page?

Add your rating