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EMA issues draft reflection paper for iron-based nano-colloidal products Posted 18/10/2013

On 7 October 2013, the European Medicines Agency (EMA) announced the publication of a draft reflection paper‡ to discuss the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicine. The draft reflection paper has been released for a five-month consultation period.
The draft reflection paper is intended to guide companies in generating relevant comparative quality, non-clinical and pharmacokinetic data to support a marketing authorization for an intravenous iron-based nano-colloidal product claiming to be similar to another one already on the market. Iron-based products are used to treat iron deficiency. They consist of a polynuclear iron core, generally present in the iron (III)-oxyhydroxide form, stabilized by a complex carbohydrate coating which leads to nano-sized colloidal aggregates. 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 characterization of nano-sized colloidal preparations indicate that quality characterization on its own would not provide sufficient assurance of the similarity between the two products, even if the quality tests performed show similarity. Therefore, EMA is proposing in this reflection paper that for the comparison of such iron-based colloidal products, data from quality, non-clinical and human pharmacokinetic studies is required. The reflection paper released for consultation is one of a number of reflection papers on nanomedicines, which EMA’s Committee for Medicinal Products for Human Use (CHMP) has been developing since 2011 to provide guidance to sponsors developing medicines in this emerging scientific area. EMA is hoping that this document will facilitate a decision on the following issues:
Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product Feedback on the draft reflection paper can be submitted to swp-h@ema.europa.eu until the 28 February 2014.
‡ Reflection paper Related articles EU guidelines for nanosimilars Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.
Date: 25 July 2013
End of consultation: 28 February 2014
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/09/WC500149496.pdf
A reflection paper is developed to communicate the current status of discussions or to invite comment on a selected area of medicinal product development or a specific topic. It can provide a framework for discussion or clarification, particularly in areas where scientific knowledge is quickly evolving or experience is limited. A reflection paper does not provide direct scientific, technical or regulatory guidance, but may contribute to future development of such guidelines or related documents, as it provides clear statements on current expectations from the regulator. Therefore, it becomes possible for researchers to define the potential weak or controversial points and further clarify these with the regulators.
Source: EMA
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