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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:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3181698/
https://www.ncbi.nlm.nih.gov/pubmed/22034129
Descripción
Sumario: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.