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
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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 -
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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 -
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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
- Biologicals: active substance
- Multidisciplinary: cell therapy and tissue engineering
- Directive 2009/120/EC
- Regulation EC no 1394/2007
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Safety and efficacy follow up - risk management of advanced therapy medicinal products
- Human cell-based medicinal products
- ICH Q5A (R1) Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
- Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
- Production and quality control of animal immunoglobins and immunosera for human use
- Quality, preclinical and clinical aspects of gene therapy medicinal products
- Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
- Scientific requirements for the environmental risk assessment of gene-therapy medicinal products