Stem cell-based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) - Scientific guideline

Current version - Revision 1

Questions and Answers on allogenic stem cell-based products for veterinary use: Specific questions on extraneous agents - Revision 1

Adopted Reference Number: EMA/CVMP/ADVENT/803494/2016-Rev.1

The guidance, in the form of questions and answers, addresses concerns raised by manufacturers and authorities regarding the appropriate measures for demonstrating freedom from extraneous agents of stem-cell based products for veterinary use. The manufacture of stem cell-based products usually does not include terminal sterilisation of the product or removal or inactivation steps for viruses and parasites and, therefore, it is important to define acceptance criteria for starting and raw materials derived from human or animal origin taking into consideration their intended use. The guidance was developed following a review of scientific and regulatory information in the veterinary and human fields in relation to stem-cell products intended for veterinary use.

Keywords: Stem cell-based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)

Document history

Questions and Answers on allogenic stem cell-based products for veterinary use: Specific questions on extraneous agents

Adopted Reference Number: EMA/CVMP/ADVENT/803494/2016

Stem cell -based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)

Draft: consultation closed Consultation dates: 27/06/2016 to 30/09/2016 Reference Number: EMA/CVMP/ADVENT/174610/2016 Summary:

Cell-based medicinal products (CBMP) are heterogeneous with regard to the origin and type of cells and to the complexity of the product.