This guideline outlines the approaches to be followed for declaring the quantitative composition / 27 labelling of medicinal products that include modified proteins as their active substance, taking into 28 account the product class and the clinically established declared value (e.g. international unit, mass 29 unit) for the non-modified product, the method of assay (biological or physico-chemical), and 30 relevance of the potency assay (i.e. correlated with clinical efficacy). For product labelling, it is 31 considered important that the chosen unitage will not be confusing in clinical practice. The product 32 information for healthcare professionals and patients must clearly differentiate the modified product 33 from the non-modified product. This document also discusses the use of the activity unit to define a 34 quality attribute during product manufacture and control.


Document details

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 open
First published 25/03/2013
Last updated 25/03/2013
Consultation start date 25/03/2013
Consultation end date 01/10/2013
Email address for submissions


Posted on the EMA website on 25 March 2013