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:
- pharmaceutical data needed as evidence of product similarity between test and reference products to support comparative safety and efficacy
- consideration to the types of non-clinical and clinical studies that are required to support the quality data in order to demonstrate similarity
Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product
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
Feedback on the draft reflection paper can be submitted to swp-h@ema.europa.eu until the 28 February 2014.
‡ Reflection paper
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.
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