Regulatory basis for the safety assessment of nanotechnology-based drug products
DOI:
https://doi.org/10.22239/2317-269X.01358Keywords:
Nanomedicine, Safety, Toxicology, Regulation, AnvisaAbstract
Introduction: Nanotechnology is a transdisciplinary technology that is being developed and applied in several areas, including health, especially in terms of therapy and diagnosis. However, the relationship between some of their physicochemical properties and their toxicological effects remains unclear. Therefore, it is necessary to understand whether the regulatory requirements, in terms of toxicological evaluation, for the registration of a nanotechnology-based drug, are able to identify the possible risks arising from this new technology. Objective: To compare the regulatory approach of US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Brazilian Health Regulatory Agency (Anvisa) with respect to nanomedicine evaluation compared to conventional drugs evaluation. Method: Qualitative bibliographic research was performed in different databases and regulatory agencies websites. Results: Many limitations of the currently recommended tests have been demonstrated, and several are under review for better adaptation to the effect that may suffer by the evaluated nanoparticles themselves. Conclusions: Toxicological tests currently recommended by the regulatory agencies of the United States of America, the European Union and Brazil, although aligned, are not specific for the evaluation of nanomedicines.
Downloads
Downloads
Published
Issue
Section
License
Copyright (c) 2020 Health Surveillance under Debate: Society, Science & Technology (Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnología) – “Visa em Debate”
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
