Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products

Wahiba Oualikene-Gonin (1) , Valérie Sautou (2, 3, 4) , Eric Ezan (5) , Henri Bastos (1) , Eric Bellissant (6, 7) , Laetitia Belgodère (1) , Patrick Maison (8, 9, 1) , Joël Ankri (10)

1 ANSM - Agence nationale de sécurité du médicament et des produits de santé [Saint-Denis]
2 CHU Louise Michel [Clermont-Ferrand]
3 ICCF - Institut de Chimie de Clermont-Ferrand
4 INP Clermont Auvergne - Institut national polytechnique Clermont Auvergne
5 Université Paris-Saclay
6 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
7 Irset - Institut de recherche en santé, environnement et travail
8 EpiDermE - Epidemiology in Dermatology and Evaluation in Therapeutics
9 CHI Créteil
10 CESP - Centre de recherche en épidémiologie et santé des populations

Nanomaterials are present in a wide variety of health products, drugs and medical devices and their use is constantly increasing, varying in terms of diversity and quantity. The topic is vast because it covers nanodrugs, but also excipients (that includes varying proportions of NMs) and medical devices (with intended or not-intended (by-products of wear) nanoparticles). Although researchers in the field of nanomedicines in clinical research and industry push for clearer definitions and relevant regulations, the endeavor is challenging due to the enormous diversity of NMs in use and their specific properties. In addition, regulatory hurdles and discrepancies are often cited as obstacles to the clinical development of these innovative products. The scientific council of the Agence Nationale de Securite du Medicament et des produits de sante (ANSM) undertook a multidisciplinary analysis encompassing fundamental, environmental and societal dimensions with the aim of identifying topics of interest for regulatory assessment and surveillance. This analysis allowed for proposing some recommendations for approximation and harmonization of international regulatory practices for the assessment of the risk/benefit balance of these products, considering as well the public expectations as regards efficacy and safety of nanomaterials used in Health products, in terms of human and environmental health.

Mots clés: nanomaterials; public health; regulatory science; nanomedicines; innovative drugs; medical devices; medicines; excipients

Domaines: Sciences du Vivant [q-bio]; Santé publique et épidémiologie

Wahiba Oualikene-Gonin, Valérie Sautou, Eric Ezan, Henri Bastos, Eric Bellissant, et al.. Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products. Frontiers in Public Health, 2023, 11, pp.1125577. ⟨10.3389/fpubh.2023.1125577⟩. ⟨hal-04058998v2⟩