Nanotechnology-based medicinal products for human use - EMA Report

The EMA released this report in January 2025 – Read the introduction and download the full 33 pages report down on the page

Introduction

Nanotechnology is a rapidly evolving scientific research field with a wide applicability. It is showing successful and beneficial uses in the fields of diagnostics, disease treatment and prevention.

In the context of medical science, it is expected that nanotechnology will contribute to unlock a broad range of applications for innovative medicinal products such as controlled drug release, targeted cancer therapies, medical imaging including theranostics, tissue engineering, etc. and will most likely be disruptive for the diagnosis and therapy of diseases in unforeseen ways.

Nanotechnology has found widespread application across various fields. In biomedical research, its utilization primarily evolves around designing and developing drug delivery systems and medical diagnosis. Nanotechnology-based drug delivery systems offer numerous advantages, including enhanced targeting of therapeutic drugs, protection against degradation during in vivo transport and controlled release at specific sites or cells in response to signals. This not only improves the therapeutic efficacy but also minimizes side effects (e.g. liposomal doxorubicin) (1). Among other advantages, the utilization of nanotechnologies in medicine can help minimizing the dosage regime (and thus mitigate adverse effects) and improve stability of active ingredients, as demonstrated by the approved mRNA COVID-19 vaccines in the form of lipid nanoparticles (2).

The European Commission (EC) first adopted a definition of a nanomaterial in 2011 (3) and a final recommendation on the definition of nanomaterial was published on 14th of June 2022 (4). According to this definition, ‘Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number-based size distribution fulfil at least one of the following conditions:

(a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
(b) the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
(c) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm. In the determination of the particle number-based size distribution, it is not necessary to consider particles with at least two orthogonal external dimensions larger than 100 μm. However, a material with a specific surface area by volume of < 6 m2/cm3 shall not be considered a nanomaterial.

The EU definition of nanomaterial is also mentioned in Regulation (EU) 2017/745 on medical devices. Nevertheless, it is important to notice that while some European legislations (e.g. REACH, Biocidal Products Regulation and Medical Devices Regulation) follow the above-mentioned definition of nanomaterial, such general legal definition is not strictly binding for medicinal products (3).

Nanotechnology-based medicinal products, nanomedicine products or nanomedicines, the medical application of nanotechnology and nanoformulations, are typically medicinal products (fulfilling the definition of the medicinal product according to European legislation), in which at least one component is at nano-scale size (e.g. active substance or excipient), resulting in definable specific properties and characteristics, related to the specific nanotechnology application and characteristics for the intended use (route of administration, dose) and associated with the expected clinical advantages of the nano-engineering (e.g. preferential organ/tissue distribution). They are used in both systemic and topical use. Major therapeutic areas are: oncology, infectious diseases (e.g. vaccines), neurology, psychiatry and genetic disorders.

However, we would like to highlight that the definition of nanomedicines could vary slightly between regions and that there is not a unique definition of nanomedicines in EU.

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Nanotechnology-based medicinal products for human use

Source: Nanotechnology-based medicinal products for human use, EU-IN Horizon Scanning Report, January 2025, EMA/20989/2025, www.ema.europa.eu, EMA/20989/2025