Consideration of R submission in Japan

Abstract

R adoption and submission are key topics in the pharmaceutical programming industry, and Japan is no exception. Although SAS users still constitute a large population in Japan, interest in R has grown significantly in recent years.

Industry communities such as Japan Pharmaceutical Manufacturers Association (JPMA) and PHUSE have conducted surveys on R adoption and initiated communication with Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese health authority. PMDA has shown openness to accepting R, and sponsors need to consider the best approaches for R submissions, including understanding PMDA-specific requirements (e.g., PMDA consultations, PMDA gateway submissions following folder structure guidelines, etc.).

In this paper, we will briefly introduce the New Drug Application (NDA) process with PMDA and highlight key points for preparing PMDA communications and R submission deliverables.