Comments invited on draft reflection paper on data requirements for iron-based nanocolloidal products developed with reference to an innovator medicine

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07/10/2013

Comments invited on draft reflection paper on data requirements for iron-based nanocolloidal products developed with reference to an innovator medicine

The European Medicines Agency has published a draft reflection paper on the data requirements for intravenous iron-based nanocolloidal products developed with reference to an innovator medicine for public consultation.

Comments should be sent using the submission form no later than 28 February 2014, to swp-h@ema.europa.eu.

Nanotechnology, or the use of tiny structures, is an emerging field in science that can be used in a wide range of applications, from consumer goods to health products.

Intravenous iron-based nanocolloidal preparations are used for the treatment of iron deficiency and contain nano-sized iron complexes.

This reflection paper is intended to guide companies in generating relevant comparative quality, non-clinical and pharmacokinetic data to support a marketing authorisation for an intravenous iron-based nanocolloidal product claiming to be similar to another one already on the market.

The reflection paper released today for consultation is the last in a series of four reflection papers on nanomedicines, which the Agency’s Committee for Medicinal Products for Human Use (CHMP) began to develop in 2011 to provide guidance to sponsors developing medicines in this emerging scientific area.

The other three guidance documents are: