Implementing Horizon Scanning as a tool for the strategic development of regulatory guidelines for nanotechnology-enabled health products

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  • dc.contributor.author Rodríguez-Gómez, Francisco D.
  • dc.contributor.author Monferrer, Dominique
  • dc.contributor.author Penon, Oriol
  • dc.contributor.author Rivera Gil, Pilar, 1976-
  • dc.date.accessioned 2024-03-19T07:32:31Z
  • dc.date.available 2024-03-19T07:32:31Z
  • dc.date.issued 2023
  • dc.description.abstract Strategic regulatory development is essential to ensure that new innovations in nanotechnology-enabled health products (NHPs) successfully reach the market and benefit patients. Currently, the lack of specific regulatory guidelines for NHPs is considered one of the primary causes of the so-called "valley of death" in these products, impacting both current and future advancements. In this study, we have implemented a methodology to anticipate key trends in NHP development and compare them with the current regulatory landscape applicable to NHPs. This methodology relies on Horizon Scanning, a tool commonly used by policymakers to foresee future needs and proactively shape a regulatory framework tailored to those needs. Through the application of this methodology, different trends in NHP have been identified, notably NHPs for drug delivery and dental applications. Furthermore, the most disruptive elements involve NHPs that are multicomposite and multifunctional, harnessing nano-scale properties to combine therapeutic and diagnostic purposes within a single product. When compared with the regulatory landscape, current regulations are gradually adapting to accommodate emerging trends, with specific guidelines being developed. However, for the most disruptive elements, multicomposite and multifunctional NHPs, their novelty still poses significant regulatory challenges, requiring a strategic development of guidelines by regulatory agencies to ensure their safe and effective integration into healthcare practices. This study underscores the importance of proactive regulatory planning to bridge the gap between NHP innovation and market implementation.
  • dc.description.sponsorship This work was supported by the Industrial Doctorates Plan of the Department of Research and Universities of the Generalitat de Catalunya (grant no 202015). PRG acknowledges the Ministry of Science, Innovation and Universities (MICINN-AEI) (AEI-PID2019-106755RB-I00 and AEI-PID2022-140423NB-I00) and the AGAUR (2021 SGR 00175 and 2021 PROD 00041) for financial support.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Rodríguez-Gómez FD, Monferrer D, Penon O, Rivera-Gil P. Implementing Horizon Scanning as a tool for the strategic development of regulatory guidelines for nanotechnology-enabled health products. Front Med (Lausanne). 2024 Jan 11;10:1308047. DOI: 10.3389/fmed.2023.1308047
  • dc.identifier.doi http://dx.doi.org/10.3389/fmed.2023.1308047
  • dc.identifier.issn 2296-858X
  • dc.identifier.uri http://hdl.handle.net/10230/59477
  • dc.language.iso eng
  • dc.publisher Frontiers
  • dc.relation.ispartof Front Med (Lausanne). 2024 Jan 11;10:1308047
  • dc.relation.projectID info:eu-repo/grantAgreement/ES/2PE/PID2019-106755RB-I00
  • dc.relation.projectID info:eu-repo/grantAgreement/ES/3PE/PID2022-140423NB-I00
  • dc.rights © 2024 Rodríguez-Gómez, Monferrer, Penon and Rivera-Gil. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (http://creativecommons.org/licenses/by/4.0/). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by/4.0/
  • dc.subject.keyword Horizon scanning
  • dc.subject.keyword Nanomedicine
  • dc.subject.keyword Nanotechnology-enabled health product
  • dc.subject.keyword Regulatory guideline
  • dc.subject.keyword Regulatory science
  • dc.title Implementing Horizon Scanning as a tool for the strategic development of regulatory guidelines for nanotechnology-enabled health products
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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