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

Public Health

Wahiba Oualikene-Gonin¹  Laëtitia Belgodère¹  Patrick Maison²  Henri Bastos³  Eric Ezan⁴  Eric Bellissant⁵  Valérie Sautou⁶  Joël Ankri⁷ 

[1] Agence nationale de sécurité du médicament et des produits de santé, Saint-Denis, France;Agence nationale de sécurité du médicament et des produits de santé, Saint-Denis, France;EA 7379, Faculté de Santé, Université Paris-Est Créteil, Créteil, France;CHI Créteil, Créteil, France;Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, Maisons-Alfort, France;Commissariat à l'énergie atomique et aux énergies alternatives, Institut national de recherche pour l'agriculture, l'alimentation et l'environnement, Département Médicaments et Technologies pour la Santé (DMTS), Université Paris-Saclay, Gif-sur-Yvette, France;Service de Pharmacologie, Centre Régional de Pharmacovigilance, de pharmaco-épidémiologie et d'information sur le médicament, CHU de Rennes, UMR INSERM 1085 - Institut de Recherche en Santé, Environnement et Travail (IRSET), Université de Rennes 1, Rennes, France;Université Clermont Auvergne, CHU Clermont Ferrand, Clermont Auvergne INP, CNRS, ICCF, Clermont-Ferrand, France;Université de Versailles St Quentin- Paris Saclay, Inserm U1018, Versailles, France;

关键词: nanomaterials;    public health;    regulatory science;    nanomedicines;    innovative drugs;    medical devices;    medicines;    excipients;   

DOI  :  10.3389/fpubh.2023.1125577

 received in 2022-12-16, accepted in 2023-02-14,  发布年份 2023

来源: Frontiers

【 摘 要 】

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 Sécurité du Médicament et des produits de santé (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.

【 授权许可】

Unknown   
Copyright © 2023 Oualikene-Gonin, Sautou, Ezan, Bastos, Bellissant, Belgodère, Maison, Ankri and the Scientific Advisory Board of the ANSM.