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:

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European Medicines Agency Consultation: draft concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

The European Medicines Agency has recently published a draft "Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues".

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Human Medicines Highlights: Issue 25 - February 2011

This newsletter is addressed to patients, consumers and healthcare professionals' organisations and is intended to provide a monthly update on key information on human medicines produced and published by the European Medicines Agency.

The information contained in each issue has been selected based on recommendations from consulted patients, consumers and healthcare professionals and is not intended to comprise a full set of the Agency's information.

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