Japan Pharmaceutical Manufacturers Association Task Forces on Utilization of Real World Data for Regulatory Submissions

Abstract

Japan Pharmaceutical Manufacturers Association (JPMA) has organized several task forces to look into utilization of Real World Data (RWD) from various aspects. One of the task forces has investigated “Pharmaceutical company’s internal process to utilize registry for filing of application for drug approval etc.” in order to facilitate the utilization of RWD for regulatory submissions (filing of application for product approval etc.). The deliverables showing the process and points to consider are aiming at encouraging pharmaceutical companies to utilize registry data. Furthermore, other stakeholders would also know the challenges for pharmaceutical companies and how they make internal decisions, expectedly leading to mutual understandings among stakeholders.