Nanotechnology

Nanotechnology is the use of tiny structures – less than 1,000 nanometres across – that are designed to have specific properties. Nanotechnology is an emerging field in science that is used in a wide range of applications, from consumer goods to health products.

In medicine, nanotechnology has only partially been exploited. It is being investigated as a way to improve the properties of medicines, such as their solubility or stability, and to develop medicines that may provide new ways to:

• deliver medicines to the body;
• target medicines in the body more accurately;
• diagnose and treat diseases;
• support the regeneration of cells and tissues.

Activities at the European Medicines Agency 

The European Medicines Agency follows the latest developments in nanotechnology that are relevant to the development of medicines. Recommendations from the Agency’sCommittee for Medicinal Products for Human Use (CHMP) have already led to the approval of a number of medicines based on nanotechnology. These include medicines containing:

• liposomes (microscopic fatty structures containing the active substance), such asCaelyx (doxorubicin), Mepact (mifamurtide) and Myocet (doxorubicin);
• nano-scale particles of the active substance, such as Abraxane (paclitaxel), Emend(aprepitant) and Rapamune (sirolimus).

The development of medicines using newer, innovative nanotechnology techniques may raise new challenges for the Agency in the future. These include discussions on whether the current regulatory framework is appropriate for these medicines and whether existing guidelines and requirements on the way the medicines are assessed and monitored are adequate.

The Agency also needs to consider the acceptability of new testing methods and the availability of experts to guide the Agency’s opinion-making.

An overview of the initiatives taken by European Union (EU) regulators in relation to the development and evaluation of nanomedicines and nanosimilars was published in the scientific journal Nanomedicines. The article describes the regulatory challenges and perspectives in this field:

• Next-generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines

Ad hoc expert group on nanomedicines

In 2009, the CHMP established an ad hoc expert group on nanomedicines.

This group includes selected experts from academia and the European regulatory network, who support the Agency’s activities by providing specialist input on new scientific knowledge and who help with the review of guidelines on nanomedicines. The group also helps the Agency’s discussions with international partners on issues concerning nanomedicines.

The group held the first ad hoc expert group meeting on nanomedicines on 29 April 2009.

Reflection papers on nanomedicines

In 2011, the CHMP began to develop in 2011 a series of four reflection papers on nanomedicines to provide guidance to sponsors developing nanomedicines.

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, have started to come off patent:

• joint Ministry of Health, Labour and Welfare / European Medicines Agency reflection paper on the development of block-copolymer-micelle medicinal products, published for a six-month public consultation in January 2013;
• reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product, published in February 2013;
• reflection paper on surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products, published in August 2013.

The fourth document, a draft reflection paper on the data requirements for intravenous iron-based nanocolloidal products developed with reference to an innovator medicine, will be released for a six-month public consultation in 2013.

International workshops on nanomedicines

The Agency organises workshops on nanomedicines to explore the scientific aspects of nanomedicines and enable the sharing of experience at an international level, in order to assist future developments in the field:

• First international workshop on nanomedicines (02-03/09/2010)