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

• DOI: 10.3389/fpubh.2023.1125577
• Publication Date: 2023-03-06T07:53:51Z
• Authors: Wahiba Oualikene-...; Valérie Sautou; Eric Ezan; Henri Bastos; Eric Bellissant; Laëtitia Belgodère; Patrick Maison; Joël Ankri
• Keywords: Harmonization; Uncertainty; Health Technology

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