Xenogeneic cell-based medicinal products

Current effective version

PDF iconAdopted guideline

Reference number CHMP/CPWP/83508/09
Published 30/11/2009
Effective from 01/01/2010
Keywords Xenogeneic, cell therapy, quality, nonclinical, clinical, transgenic animals
Description 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.


Document history

First version

Current version

PDF iconAdopted guideline

 

PDF iconDraft guideline

 

PDF iconConcept paper

In operation: 01/01/2010–present

 

Published: 27/02/2009

 

Published: 17/12/2003


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