Open AccessQuantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
Author(s) -
Sato M,
Ochiai Y,
Kijima S,
Nagai N,
Ando Y,
Shikano M,
Nomura Y
Publication year - 2017
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12203
Subject(s) - regulatory agency , agency (philosophy) , perspective (graphical) , quantitative analysis (chemistry) , quantitative assessment , computer science , business , political science , chemistry , public administration , risk analysis (engineering) , sociology , chromatography , artificial intelligence , social science
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.