Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins

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Download document Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
Reference number EMA/275542/2013
Status draft: consultation open
First published 25/03/2014
Last updated 25/03/2014
Consultation start date 25/03/2014
Consultation end date 30/06/2014
Email address for submissions bmwp.secretariat@ema.europa.eu

Summary

The Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins, CHMP/BMWP/42832/2005 laid down general recommendations for the performance of a systematic immunogenicity assessment from a marketing authorisation perspective.