EMA’s view on coated nanomedicines general issues published

16-8-2013 — /EuropaWire/ — The European Medicines Agency has published a reflection paper on general issues for consideration regarding the parenteral administration of coated nanomedicines today.

The reflection paper describes general issues to consider during the development of nanomedicines that have a coating, including:

• the effect of the coating on the stability, the pharmacokinetics and the biodistribution of the medicine;
• the potential interaction of the coating with other molecules in the biological environment and the potential consequences of such interactions.

Surface coating is often used to minimise aggregation and improve the stability of medicines.

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.

In medicine, nanotechnology has the potential to open up new possibilities for the improvement of the properties of medicines, such as their solubility or stability, and the development of more efficient ways to deliver medicines and target them accurately in the body.

The document published today is one of 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. These documents cover the development both of new nanomedicines and of nanosimilars (nanomedicines that are claimed to be similar to a reference nanomedicine), since the first generation of nanomedicines, including liposomal formulations, iron-based preparations and nanocrystal-based medicines, are now coming off patent.

The other three guidance documents are:

• a final reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product, which was published in February 2013;
• a draft reflection paper on the development of block-copolymer-micelle medicines, jointly developed by the Agency and the Japanese Ministry of Health, Labour and Welfare, whose six-month public consultation phase closed in July 2013;
• a draft reflection paper on the data requirements for intravenous iron-based nanocolloidal products developed with reference to an innovator medicine, which will be released for a six-month public consultation later this year.

An overview of the initiatives taken by European Union (EU) regulators in relation to the development and evaluation of nanomedicines and nanosimilars has recently been published in the scientific journal Nanomedicines. This article, next-generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines, describes the regulatory challenges and perspectives in this field.

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