Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance

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Download document Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance
Reference number EMA/CHMP/BWP/85290/2012
Status draft: consultation closed
First published 25/03/2013
Last updated 25/03/2013

Summary

This guideline outlines the approaches to be followed for declaring the quantitative composition / labelling of medicinal products that include modified proteins as their active substance, taking into account the product class and the clinically established declared value (e.g. international unit, mass unit) for the non-modified product, the method of assay (biological or physico-chemical), and relevance of the potency assay (i.e. correlated with clinical efficacy).