Creutzfeldt-Jakob disease and advanced therapy medicinal products - Scientific guideline

This document considers the risk of transmitting Creutzfeldt-Jakob disease (CJD) or variant CJD agents via the advanced therapy medicinal products.

Keywords: Creutzfeldt-Jakob disease, gene therapy, cell therapy and tissue engineering medicinal products, donor selection criteria, tissue and blood donation

Current effective version

CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced-therapy medicinal products

Adopted Reference Number: EMA/CHMP/BWP/353632/2010 Summary:

In the European regulation advanced therapy medicinal products (ATMP) include those based on gene therapy, cell therapy and tissue engineering. Although they are considered biological medicinal products as described in the directive 2001/83/EC, specific legislation has also been developed (Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products).

Document history - First version (current)

CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced-therapy medicinal products

Adopted Reference Number: EMA/CHMP/BWP/353632/2010 Summary:

In the European regulation advanced therapy medicinal products (ATMP) include those based on gene therapy, cell therapy and tissue engineering. Although they are considered biological medicinal products as described in the directive 2001/83/EC, specific legislation has also been developed (Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products).

Overview of comments received on 'CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced-therapy medicinal products'

Reference Number: EMA/CHMP/BWP/782739/2010

Draft CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products

Draft: consultation closed Consultation dates: 24/06/2010 to 30/09/2010 Reference Number: EMA/CHMP/CAT/BWP/353632/2010