Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

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Download document Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product
Reference number EMA/CHMP/SWP/620008/2012
Status draft: consultation open
First published 16/09/2013
Last updated 16/09/2013
Consultation start date 15/09/2013
Consultation end date 28/02/2014
Email address for submissions swp-h@ema.europa.eu

Summary

This reflection paper discusses the data requirements for nano-sized colloidal intravenous iron-based preparations developed as a treatment for iron deficiency with reference to a nano-sized colloidal innovator products. For the comparison of iron-based nano-sized colloidal products developed with reference to an innovator medicinal product, current scientific knowledge and regulatory experience for characterisation of nano-sized colloidal preparations indicate that quality characterisation on its own would not provide sufficient assurance of the similarity between the two products, even if the quality tests performed show similarity. In the context of such iron-based preparations, a 'weight-of-evidence approach' including data from quality, non-clinical and human pharmacokinetic studies is required.