EMA releases potency labelling advice

Published: 21-Apr-2014
Regulatory

Manufacturers should consider product class, mass unit and assay methods


The European Medicines Agency (EMA) has released guidance on declaring quantitative composition and potency labelling regarding biological medicinal products with modified proteins as an active substance.

The advice says manufacturers should take into account the product class, mass unit and assay methods. For product labelling, chosen unit systems must avoid prompting confusion in clinical practice, it said.

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