Cargando…
Regenerative technologies to bed side: Evolving the regulatory framework
There are high expectations for the clinical application of regenerative medicine technologies to treat musculoskeletal disorders. However, there are still big hurdles in bringing cell-based products to the market, mainly due to strict regulatory frameworks to approve these. Recently, the Japanese P...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Chinese Speaking Orthopaedic Society
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5822969/ https://www.ncbi.nlm.nih.gov/pubmed/29662794 http://dx.doi.org/10.1016/j.jot.2017.02.001 |
_version_ | 1783301791816876032 |
---|---|
author | Sakai, Daisuke Schol, Jordy Foldager, Casper B. Sato, Masato Watanabe, Masahiko |
author_facet | Sakai, Daisuke Schol, Jordy Foldager, Casper B. Sato, Masato Watanabe, Masahiko |
author_sort | Sakai, Daisuke |
collection | PubMed |
description | There are high expectations for the clinical application of regenerative medicine technologies to treat musculoskeletal disorders. However, there are still big hurdles in bringing cell-based products to the market, mainly due to strict regulatory frameworks to approve these. Recently, the Japanese Pharmaceuticals and Medical Devices Agency adopted new regulations under legislature. The translational potential of this article is to inform on the regulations to bring experimental phase regenerative concepts to market approval in the United States and Europe, and highlight the opportunities granted by Japanese regulatory framework. Furthermore, we discuss the perspectives on the quickly evolving regulatory environment. |
format | Online Article Text |
id | pubmed-5822969 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Chinese Speaking Orthopaedic Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-58229692018-04-16 Regenerative technologies to bed side: Evolving the regulatory framework Sakai, Daisuke Schol, Jordy Foldager, Casper B. Sato, Masato Watanabe, Masahiko J Orthop Translat Review Article There are high expectations for the clinical application of regenerative medicine technologies to treat musculoskeletal disorders. However, there are still big hurdles in bringing cell-based products to the market, mainly due to strict regulatory frameworks to approve these. Recently, the Japanese Pharmaceuticals and Medical Devices Agency adopted new regulations under legislature. The translational potential of this article is to inform on the regulations to bring experimental phase regenerative concepts to market approval in the United States and Europe, and highlight the opportunities granted by Japanese regulatory framework. Furthermore, we discuss the perspectives on the quickly evolving regulatory environment. Chinese Speaking Orthopaedic Society 2017-03-02 /pmc/articles/PMC5822969/ /pubmed/29662794 http://dx.doi.org/10.1016/j.jot.2017.02.001 Text en © 2017 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Review Article Sakai, Daisuke Schol, Jordy Foldager, Casper B. Sato, Masato Watanabe, Masahiko Regenerative technologies to bed side: Evolving the regulatory framework |
title | Regenerative technologies to bed side: Evolving the regulatory framework |
title_full | Regenerative technologies to bed side: Evolving the regulatory framework |
title_fullStr | Regenerative technologies to bed side: Evolving the regulatory framework |
title_full_unstemmed | Regenerative technologies to bed side: Evolving the regulatory framework |
title_short | Regenerative technologies to bed side: Evolving the regulatory framework |
title_sort | regenerative technologies to bed side: evolving the regulatory framework |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5822969/ https://www.ncbi.nlm.nih.gov/pubmed/29662794 http://dx.doi.org/10.1016/j.jot.2017.02.001 |
work_keys_str_mv | AT sakaidaisuke regenerativetechnologiestobedsideevolvingtheregulatoryframework AT scholjordy regenerativetechnologiestobedsideevolvingtheregulatoryframework AT foldagercasperb regenerativetechnologiestobedsideevolvingtheregulatoryframework AT satomasato regenerativetechnologiestobedsideevolvingtheregulatoryframework AT watanabemasahiko regenerativetechnologiestobedsideevolvingtheregulatoryframework |