Japanese pharmaceutical and regulatory environment

Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in t...

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Detalles Bibliográficos
Autores principales: Nagata, Ryoichi, Raflzadeh-Kabe, Jean-David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Les Laboratoires Servier 2002
Materias:
Clinical Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3181698/
https://www.ncbi.nlm.nih.gov/pubmed/22034129
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author Nagata, Ryoichi
Raflzadeh-Kabe, Jean-David
author_facet Nagata, Ryoichi
Raflzadeh-Kabe, Jean-David
author_sort Nagata, Ryoichi
collection PubMed
description Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities.
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spelling pubmed-31816982011-10-27 Japanese pharmaceutical and regulatory environment Nagata, Ryoichi Raflzadeh-Kabe, Jean-David Dialogues Clin Neurosci Clinical Research Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities. Les Laboratoires Servier 2002-12 /pmc/articles/PMC3181698/ /pubmed/22034129 Text en Copyright: © 2002 LLS http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Research
Nagata, Ryoichi
Raflzadeh-Kabe, Jean-David
Japanese pharmaceutical and regulatory environment
title Japanese pharmaceutical and regulatory environment
title_full Japanese pharmaceutical and regulatory environment
title_fullStr Japanese pharmaceutical and regulatory environment
title_full_unstemmed Japanese pharmaceutical and regulatory environment
title_short Japanese pharmaceutical and regulatory environment
title_sort japanese pharmaceutical and regulatory environment
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3181698/
https://www.ncbi.nlm.nih.gov/pubmed/22034129
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