Potency declaration/labelling for biological medicinal products which contain modified proteins as active substance - Scientific guideline

This document reflects the need for a guideline for potency assignment of modified proteins. It shall apply to proteins for which an International Standard exists or where a clinical recognised unit exists (without an International Standard established) for the non-modified product.

Keywords: Modified proteins, potency, international standard

Current effective version

Concept paper on potency declaration / labelling for biological medicinal products which contain modified proteins as active substance

Draft: consultation closed Consultation dates: 17/02/2011 to 17/05/2011 Reference Number: EMA/CHMP/BWP/776563/2010 Summary:

This concept paper aims to provide the rationale for drafting a guidance document for potency

24 assignment of modified proteins for which an International Standard exists or where a clinical

25 recognised unit exists (without an International Standard established) for the non-modified product.