Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective

In Japan in October 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) began to receive electronic data in new drug applications (NDAs). These electronic data are useful to conduct regulatory assessment of sponsors’ submissions and contribute to the PMDA's research. In this article, we...

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Detalles Bibliográficos
Autores principales: Sato, M, Ochiai, Y, Kijima, S, Nagai, N, Ando, Y, Shikano, M, Nomura, Y
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5529733/
https://www.ncbi.nlm.nih.gov/pubmed/28568566
http://dx.doi.org/10.1002/psp4.12203
Descripción
Sumario:In Japan in October 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) began to receive electronic data in new drug applications (NDAs). These electronic data are useful to conduct regulatory assessment of sponsors’ submissions and contribute to the PMDA's research. In this article, we summarize the number of submissions of quantitative modeling and simulation (M&S) documents in NDAs in Japan, and we describe our current thinking and activities about quantitative M&S in PMDA.

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