Evidence map›Paper›PMID 36935690›Full record

ArticleFrontiers in public health2023

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, Valérie Sautou, Eric Ezan, Henri Bastos, Eric Bellissant, Laëtitia Belgodère, Patrick Maison, Joël Ankri, Scientific Advisory Board of the ANSM

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In one paragraph

Article in Frontiers in public health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed.

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  20. CAR T Cell Nanosymbionts: Revealing the Boundless Potential of a New Dyad.International journal of molecular sciences · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Wahiba Oualikene-GoninAgence nationale de sécurité du médicament et des produits de santé, Saint-Denis, France.
Valérie SautouUniversité Clermont Auvergne, CHU Clermont Ferrand, Clermont Auvergne INP, CNRS, ICCF, Clermont-Ferrand, France.
Eric EzanCommissariat 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.
Henri BastosAgence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, Maisons-Alfort, France.
Eric BellissantService 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.
Laëtitia BelgodèreAgence nationale de sécurité du médicament et des produits de santé, Saint-Denis, France.
Patrick MaisonAgence nationale de sécurité du médicament et des produits de santé, Saint-Denis, France.
Joël AnkriUniversité de Versailles St Quentin- Paris Saclay, Inserm U1018, Versailles, France.
Scientific Advisory Board of the ANSM

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

IndustryPublic HealthHumansexcipientsinnovative drugsmedical devicesmedicinesnanomaterialsnanomedicinespublic healthregulatory science

Identifiers

PMID36935690
PMCPMC10018019

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.