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. 2023 Jul 14:10:1212949.
doi: 10.3389/fmed.2023.1212949. eCollection 2023.

Classification system for nanotechnology-enabled health products with both scientific and regulatory application

Francisco D Rodríguez-Gómez  1   2 , Oriol Penon  1 , Dominique Monferrer  1 , Pilar Rivera-Gil  2
Affiliations

Classification system for nanotechnology-enabled health products with both scientific and regulatory application

Francisco D Rodríguez-Gómez et al. Front Med (Lausanne). .

Abstract

The lack of specific regulatory guidelines for nanotechnology-enabled health products (NHPs) is hampering development and patient access to these innovative technologies. Namely, there is an urgent need for harmonized regulatory definitions and classification systems that allow establishing a standardized framework for NHPs regulatory assessment. In this work, a novel classification system for NHPs is proposed. This classification can be applied for sorting nano-based innovations and regulatory guidelines according to the type of NHPs they address. Said methodology combines scientific and regulatory principles and it is based on the following criteria: principal mode of action, chemical composition, medical purpose and nanomanufacturing approach. This classification system could serve as a useful tool to sensor the state of the art of NHPs which is particularly useful for regulators to support strategy development of regulatory guidelines. Additionally, this tool would also allow manufacturers of NHPs to align their development plans with their applicable guidelines and standards and thus fulfill regulators expectations.

Keywords: classification; nanomedicines; nanotechnology enabled health products; regulatory science; regulatory uncertainties.

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Conflict of interest statement

Authors FDRG, OP, and DM were employed by company Asphalion SL. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Analysis of literature search for nanonotechnology-enabled-healthcare-product-related manuscripts. (A) It shows the number of publications referring to NHPs has always followed an increasing trend over the last 20 years. (B) Regarding the top 20 countries with the highest number of scientific publications, EEA, China and the USA, are the regions with the highest number of publications in ascending order. Scopus database, literature search carried out in May 2023 by using search string ‘nanomedicine OR “nanomedical device” OR (nano* AND health)’.
Figure 2
Figure 2
Valley of death in nanotechnology-enabled health products (NHPs) development. The number of nanotechnology-enabled health products (NHPs) at an early-medium stage of research and development is represented by the number of scientific publications and patents related to NHPs. Additionally, the number of clinical studies with NHPs is a marker of the number of applications reaching the latest stages of clinical development, close to regulatory approval. When comparing both markers with the number of NHPs currently in use, a valley of death can be noticed.
Figure 3
Figure 3
Materials classified as nanomaterials depending on the applicable legislative framework or regulatory guidance.
Figure 4
Figure 4
Proposed nanotechnology-enabled health products classification system.
Figure 5
Figure 5
Percentage of regulatory documents according to their number of defined criteria. Regulatory documents listed in the created regulatory database have been classified according to the number of defined criteria as an indicator of their degree of specificity. This means that regulatory documents with none of their classification criteria defined are general, non-specific with regards to NHPs. On the side, regulatory documents with all their classification criteria defined are specific as they address NHPs with concrete features as defined according to the classification system.
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