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.


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