Nanomedicine is the use of nanotechnology in medicine to develop new medicinal products, diagnostic procedures and medical devices. Nanotechnology is expected to be used to a greater extent in the development of medicinal products and medical devices in the future.

Applicants wishing to market a medicinal product in Europe must demonstrate its quality, efficacy and safety as well as a favourable risk-benefit ratio.

For nanomedicines the structure of the active ingredients and the formulation can be highly complex. In order to characterize them comprehensively, a combination of various innovative analytical methods is necessary. Also after a medicinal product has been granted marketing authorisation, the experience gained during its use is continuously and systematically collected and evaluated.

In order to meet the new challenges posed by the use of nanotechnology, a working group (nanomedicine working group) was established at the Federal Institute for Drugs and Medical Devices (BfArM) to deal with these new/innovative technologies.

Since the term nanomedicine has not yet been harmonised at European level, the working group has committed itself to the following definition: Nanomedicine is the application of mostly synthetically produced substances and structures which, due to their size (< 100 nm), have new specific properties and which are intended for medical purposes such as diagnosis and treatment of diseases in the sense of the European Legislation for medicinal products and medical devices.

According to the EU Commission's definition of nanomaterials, certain pharmaceuticals and medical devices can also be classified as nanomedicine if the final product is designed in such a way that it exhibits properties, such as chemical or physical characteristics specific to the product class, which are attributable to its dimension(s), even if these dimensions are outside the nanometer range.

The interdisciplinary working group brings together BfArM internal expertise with the aim of ensuring proper handling of tasks relating to pharmaceutical and medical products whose application falls under the definition of nanomedicine, e.g.:

• Approval of clinical trials,
• Marketing authorisation applications,
• Medicinal product monitoring/pharmacovigilance
• Risk assessment of medical devices

Within the working group, it is determined for the BfArM which medicinal products and medical devices are to be classified under the term nanomedicine and whether specific requirements for product safety are to be imposed if necessary. This is done in compliance with the applicable EU regulations for medicinal products and medical devices.

The working group follows current developments in the field of nanomedicine and cultivates the exchange with external experts and committees and actively participates in the discussion on the harmonization of the term nanomedicine in the corresponding EU and global committees.

Contact: nanomedizin@bfarm.de