Perspectives of drug development using new approach methodologies

One of the mission of regulatory science is to promote human longevity by providing safer and more effective drugs and ensuring human health. At present, various in vitro and in vivo evaluation methods are used for drug development, and no major problems have been observed. Although the conventional non-clinical testing methods can predict clinical outcomes, there is still some room for improvement in terms of risk prediction in humans. Thus, new approach methodologies (NAMs) have been expected to predict adverse events in humans more accurately. Based on the international trend on animal alternative methods and the current COVID-19 pandemic, in vitro methods and computational approach are accelerated to improve the efficiency of drug development, ensure the patients' safety and speed up the review process.