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Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine
The first issue of Nature Medicine published 20 years ago featured an article that reported Japan's critical situation regarding clinical trials, calling for major reform. Twenty years later, Japan has enacted three laws to promote the use of regenerative medicine as a national policy. The firs...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Japanese Society for Regenerative Medicine
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6581824/ https://www.ncbi.nlm.nih.gov/pubmed/31245489 http://dx.doi.org/10.1016/j.reth.2016.04.001 |
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author | Tobita, Morikuni Konomi, Kenji Torashima, Yasuhiro Kimura, Kenichi Taoka, Masaomi Kaminota, Masahiro |
author_facet | Tobita, Morikuni Konomi, Kenji Torashima, Yasuhiro Kimura, Kenichi Taoka, Masaomi Kaminota, Masahiro |
author_sort | Tobita, Morikuni |
collection | PubMed |
description | The first issue of Nature Medicine published 20 years ago featured an article that reported Japan's critical situation regarding clinical trials, calling for major reform. Twenty years later, Japan has enacted three laws to promote the use of regenerative medicine as a national policy. The first law to be enacted was the Regenerative Medicine Promotion Act, which represents the country's determination to work toward the promotion of regenerative medicine. Subsequently, the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act) and the Act on the Safety of Regenerative Medicine (RM Act) came into effect. The PMD Act created a new category for regenerative medicine products, and established the process for obtaining approval for cell therapy and other regenerative therapies through the implementation of clinical trials. The RM Act specified the regulations that doctors, review committees, and cell culture/processing facilities must adhere to when providing regenerative medicine in medical care, not only in clinical research but also in private practice. Previously, researchers in regenerative medicine only had a set of guidelines to follow for conducting clinical research. Now, with the enactment of the RM Act, all areas for improvement that had been enumerated 20 years ago—such as the lack of appropriate review committees and governmental control—have been addressed by law, creating a system that gives the highest priority to patient safety. In this paper, we present the particularly noteworthy points of the RM Act, along with the actual current conditions of regenerative medicine in Japanese medical care. |
format | Online Article Text |
id | pubmed-6581824 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Japanese Society for Regenerative Medicine |
record_format | MEDLINE/PubMed |
spelling | pubmed-65818242019-06-26 Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine Tobita, Morikuni Konomi, Kenji Torashima, Yasuhiro Kimura, Kenichi Taoka, Masaomi Kaminota, Masahiro Regen Ther Commentary The first issue of Nature Medicine published 20 years ago featured an article that reported Japan's critical situation regarding clinical trials, calling for major reform. Twenty years later, Japan has enacted three laws to promote the use of regenerative medicine as a national policy. The first law to be enacted was the Regenerative Medicine Promotion Act, which represents the country's determination to work toward the promotion of regenerative medicine. Subsequently, the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act) and the Act on the Safety of Regenerative Medicine (RM Act) came into effect. The PMD Act created a new category for regenerative medicine products, and established the process for obtaining approval for cell therapy and other regenerative therapies through the implementation of clinical trials. The RM Act specified the regulations that doctors, review committees, and cell culture/processing facilities must adhere to when providing regenerative medicine in medical care, not only in clinical research but also in private practice. Previously, researchers in regenerative medicine only had a set of guidelines to follow for conducting clinical research. Now, with the enactment of the RM Act, all areas for improvement that had been enumerated 20 years ago—such as the lack of appropriate review committees and governmental control—have been addressed by law, creating a system that gives the highest priority to patient safety. In this paper, we present the particularly noteworthy points of the RM Act, along with the actual current conditions of regenerative medicine in Japanese medical care. Japanese Society for Regenerative Medicine 2016-05-31 /pmc/articles/PMC6581824/ /pubmed/31245489 http://dx.doi.org/10.1016/j.reth.2016.04.001 Text en © 2016, The Japanese Society for Regenerative Medicine. Production and hosting by Elsevier B.V. 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 | Commentary Tobita, Morikuni Konomi, Kenji Torashima, Yasuhiro Kimura, Kenichi Taoka, Masaomi Kaminota, Masahiro Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine |
title | Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine |
title_full | Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine |
title_fullStr | Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine |
title_full_unstemmed | Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine |
title_short | Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine |
title_sort | japan's challenges of translational regenerative medicine: act on the safety of regenerative medicine |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6581824/ https://www.ncbi.nlm.nih.gov/pubmed/31245489 http://dx.doi.org/10.1016/j.reth.2016.04.001 |
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