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PSP Publishes the First Modeling and Simulation Report from Japan's PMDA

PSP Publishes the First Modeling and Simulation Report from Japan's PMDA

The perspective "Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective" by Sato and colleagues is the first report on the current state of modeling and simulations (M&S) in Japan's Pharmaceutical and Medical Device Agency (PMDA) in a peer-reviewed journal. It is also the first report by the PMDA published in CPT: Pharmacometrics & Systems Pharmacology (PSP), following several impactful reports on regulatory quantitative sciences from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) (Manolis 2013, Sheppard 2015, Wagner 2015, Manolis 2017, Musuamba 2017).

Besides being symbolic, the article presents impressive achievements from M&S colleagues in the PMDA, including the inception of receiving electronic data starting less than a year ago, statistics of the reviews, as well as preliminary recommendations on PopPK and PBPK analyses, and cases in which PBPK has been used to support recommendations in Japan's product labels.

The report has noticeable discussions on PBPK. The PMDA reviewed 17 new drug applications submissions for new molecular entities that included PBPK analyses within a rather short span between 2014 and 2016. The same period saw the significant increase in PBPK reviews by the US FDA and the EMA, as well as publication of the EMA's draft PBPK guideline and the FDA's draft PBPK guidance.

PBPK has been growing rapidly within pharmacometrics and systems pharmacology, illustrated by the large number of publications in the PSP Virtual Issue dedicated to this topic. Apparently, the PMDA has established capacity to handle PBPK submissions. The positive commitment implied in the article is not surprising. Several authors either participated closely in recent PBPK workshops held by the FDA and the EMA on policy development, attended regulator inter-agency discussions as stated in the article, or engaged in PBPK review discussions by visiting the US FDA as sabbaticals in recent years. It has to be noted that the major application of PBPK is to address drug-drug interaction questions. The PMDA works closely with Japan's top drug disposition and PK scientists, who themselves have either pioneered or long adopted PBPK for developing DDI guidelines.

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