Xenogeneic cell-based medicinal products

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Current effective version

Adopted guideline

Reference numberCHMP/CPWP/83508/09
Published30/11/2009
Effective from01/01/2010
KeywordsXenogeneic, cell therapy, quality, nonclinical, clinical, transgenic animals
DescriptionThis 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

Adopted guideline


Draft guideline


Concept paper

In operation: 01/01/2010–present


Published: 27/02/2009


Published: 17/12/2003


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