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Review
. 2025 Mar 5:12:1544393.
doi: 10.3389/fmed.2025.1544393. eCollection 2025.

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

Francisco D Rodríguez-Gómez  1   2 , Dominique Monferrer  1   3 , Oriol Penon  1 , Pilar Rivera-Gil  2
Affiliations
Review

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

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

Abstract

The integration of nanotechnology into healthcare has introduced Nanotechnology-Enabled Health Products (NHPs), promising revolutionary advancements in medical treatments and diagnostics. Despite their potential, the regulatory navigation for these products remains complex and often lagging, creating barriers to their clinical application. This review article focuses on dissecting the regulatory landscape for NHPs, particularly in the European Union and the United States, to identify applicable requirements and the main regulatory guidelines currently available for meeting regulatory expectations.

Keywords: European Union; United States; healthcare innovation; medical regulations; nanotechnology-enabled health products; regulatory pathways.

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Conflict of interest statement

FRG, 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. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

Figures

Figure 1
Figure 1
Types of nanomaterials based on the number of dimensions within the nanoscale.
Figure 2
Figure 2
Increased surface area in nanomaterials.
Figure 3
Figure 3
Examples of applications of nanotechnology-enabled health products. Adapted from ‘Figure 1’ of Acebes-Fernández et al. (101).
Figure 4
Figure 4
Electronic Common Technical Dossier (eCTD) format [taken from (34)].
Figure 5
Figure 5
Extract from SCENIHR guidance for the determination of potential of internal exposure to nanomaterials in medical devices.
Figure 6
Figure 6
State of the art from a regulatory perspective.
See this image and copyright information in PMC

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