Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective

Abstract

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.

Toward Dynamic Prescribing Information: Codevelopment of Companion Model‐Informed Precision Dosing Tools in Drug Development

“…The tool kit of quantitative approaches for MIDD has been described previously and includes PBPK modeling and simulation (M&S) . Over the last decade there has been a steady increase in PBPK models to support new drug applications to the U.S. FDA, the European Medicines Agency, and the Japanese Pharmaceuticals and Medical Devices Agency . Guidelines for PBPK models are now available to improve the quality and consistency of applications by pharmaceutical companies to regulators .…”

“…19 Over the last decade there has been a steady increase in PBPK models to support new drug applications to the U.S. FDA, 20,21 the European Medicines Agency, 22 and the Japanese Pharmaceuticals and Medical Devices Agency. 23 Guidelines for PBPK models are now available to improve the quality and consistency of applications by pharmaceutical companies to regulators. 24,25 These guidelines are also being applied in academic-initiated research.…”

Model Informed Drug Development and Regulation in China: Challenges and Opportunities

“…The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have either used M&S methods or evaluated sponsor's models to address a variety of drug development and regulatory questions and to support regulatory decision making . The Pharmaceuticals and Medical Devices Agency in Japan also organized an internal discussion group and made efforts to use M&S techniques in regulatory decisions …”

“…[2][3][4] The Pharmaceuticals and Medical Devices Agency in Japan also organized an internal discussion group and made efforts to use M&S techniques in regulatory decisions. 5 In comparison, for several decades, drug development and regulation in China primarily focused on generic drug products. During this period, the application of quantitative analysis by sponsors and review staff at the Center for Drug Evaluation (CDE) in National Medical Product Agency (NMPA) was restrained to statistical assessment of bioequivalence.…”

Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17 (5):593–606, Sep/Oct 2018, DOI: 10.1002/pst.1873

“…The Food and Drug Administration (FDA) elevated pharmacometrics to become a division in 2009 . The European Medicines Agency (EMA) established a modeling and simulation working party with pharmacometrics experts at the local country agencies and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan is in the process of establishing a pharmacometrics structure And last but not least, a name for the newborn: pharmacometrics evolved out of pharmacokinetics and pharmacodynamics, modeling and simulation, quantitative pharmacology, and a few other interim labels. The term pharmacometrics was coined almost four decades ago but caught on very slowly.…”