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Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?

Recent years have seen the establishment of several radionuclides as medicinal products in particular in the setting of theranostics and PET. [(177)Lu]Lutetium Chloride or [(64)Cu]Copper Chloride have received marketing authorization as radionuclide precursor, [(68)Ga]Gallium Chloride has received r...

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Detalles Bibliográficos
Autores principales: Decristoforo, Clemens, Neels, Oliver, Patt, Marianne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8192700/
https://www.ncbi.nlm.nih.gov/pubmed/34124109
http://dx.doi.org/10.3389/fmed.2021.678452
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author Decristoforo, Clemens
Neels, Oliver
Patt, Marianne
author_facet Decristoforo, Clemens
Neels, Oliver
Patt, Marianne
author_sort Decristoforo, Clemens
collection PubMed
description Recent years have seen the establishment of several radionuclides as medicinal products in particular in the setting of theranostics and PET. [(177)Lu]Lutetium Chloride or [(64)Cu]Copper Chloride have received marketing authorization as radionuclide precursor, [(68)Ga]Gallium Chloride has received regulatory approval in the form of different (68)Ge/(68)Ga generators. This is a formal requirement by the EU directive 2001/83, even though for some of these radionuclide precursors no licensed kit is available that can be combined to obtain a final radiopharmaceuticals, as it is the case for Technetium-99m. In view of several highly promising, especially metallic radionuclides for theranostic applications in a wider sense, the strict regulatory environment poses the risk of slowing down development, in particular for radionuclide producers that want to provide innovative radionuclides for clinical research purposes, which is the basis for their further establishment. In this paper we address the regulatory framework for novel radionuclides within the EU, the current challenges in particular related to clinical translation and potential options to support translational development within Europe and worldwide.
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spelling pubmed-81927002021-06-12 Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit? Decristoforo, Clemens Neels, Oliver Patt, Marianne Front Med (Lausanne) Medicine Recent years have seen the establishment of several radionuclides as medicinal products in particular in the setting of theranostics and PET. [(177)Lu]Lutetium Chloride or [(64)Cu]Copper Chloride have received marketing authorization as radionuclide precursor, [(68)Ga]Gallium Chloride has received regulatory approval in the form of different (68)Ge/(68)Ga generators. This is a formal requirement by the EU directive 2001/83, even though for some of these radionuclide precursors no licensed kit is available that can be combined to obtain a final radiopharmaceuticals, as it is the case for Technetium-99m. In view of several highly promising, especially metallic radionuclides for theranostic applications in a wider sense, the strict regulatory environment poses the risk of slowing down development, in particular for radionuclide producers that want to provide innovative radionuclides for clinical research purposes, which is the basis for their further establishment. In this paper we address the regulatory framework for novel radionuclides within the EU, the current challenges in particular related to clinical translation and potential options to support translational development within Europe and worldwide. Frontiers Media S.A. 2021-05-28 /pmc/articles/PMC8192700/ /pubmed/34124109 http://dx.doi.org/10.3389/fmed.2021.678452 Text en Copyright © 2021 Decristoforo, Neels and Patt. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). 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.
spellingShingle Medicine
Decristoforo, Clemens
Neels, Oliver
Patt, Marianne
Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?
title Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?
title_full Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?
title_fullStr Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?
title_full_unstemmed Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?
title_short Emerging Radionuclides in a Regulatory Framework for Medicinal Products – How Do They Fit?
title_sort emerging radionuclides in a regulatory framework for medicinal products – how do they fit?
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8192700/
https://www.ncbi.nlm.nih.gov/pubmed/34124109
http://dx.doi.org/10.3389/fmed.2021.678452
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