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

20.09.2013
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.