Xenogeneic cell-based medicinal products - Scientific guideline
Table of contents
This document addresses the scientific requirements for medicinal products that contain viable animal cells or tissues as an active substance (xenogeneic cell-based medicinal products). It provides general principles for the development and assessment of xenogeneic cell-based products without prejudice to medical practice or national legislation, which may be applicable.
Keywords: Xenogeneic, cell therapy, quality, nonclinical, clinical, transgenic animals
-
List item
Guideline on xenogeneic cell-based medicinal products (PDF/122.87 KB)
Adopted
First published: 01/12/2009
Last updated: 01/12/2009
EMEA/CHMP/CPWP/83508/2009 -
List item
Draft guideline on xenogeneic cell-based medicinal products (PDF/130 KB)
Draft: consultation closed
First published: 27/02/2009
Last updated: 27/02/2009
EMEA/CHMP/CPWP/83508/2009 -
List item
Points to consider on xenogeneic cell therapy medicinal products (PDF/298.36 KB)
First published: 17/12/2003
Last updated: 17/12/2003
CPMP/1199/02