European Medicines Agency Consultation: Concept paper on potency declaration / labelling for biological medicinal products which contain modified proteins as active substance

The European Medicines Agency has recently published a draft concept paper on potency declaration/labelling for biological medicinal products which contain modified proteins as active substance

This concept paper aims to provide the rationale for drafting a guidance document for potency assignment of modified proteins for which an International Standard exists or where a clinical recognised unit exists (without an International Standard established) for the non-modified product.

The document is available for consultation on the following webpage:

http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/...

Comments related to this draft concept paper should be provided using this template. The completed comments form should be sent to brigitte.neugebauer@ema.europa.eu.

Please note that the deadline for comments for this draft concept paper is 17 May 2011.

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