Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product - Scientific guideline

This document assists in the generation of relevant quality, non-clinical and pharmacokinetic clinical comparative data to support a marketing authorisation for an intravenous iron-based nano-colloidal product developed with reference to an innovator product.

Keywords: Nano-sized colloidal intravenous iron preparation, similarity, reference medicinal product, pharmaceutical, non-clinical, clinical, characterisation, tissue bio-distribution

Current effective version

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

Adopted Reference Number: EMA/CHMP/SWP/620008/2012

Document history - First version (current)

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

Adopted Reference Number: EMA/CHMP/SWP/620008/2012

Overview of comments received on Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

Reference Number: EMA/179672/2014

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

Draft: consultation closed Consultation dates: 15/09/2013 to 28/02/2014 Reference Number: EMA/CHMP/SWP/620008/2012 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.

Document history - Superseded document

Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications

Adopted Reference Number: EMA/CHMP/SWP/100094/2011