A questionnaire survey on discussions between pharmaceutical companies and PMDA in non-clinical safety assessment of pharmaceuticals

Abstract

It is often argued the requirement of the toxicity study or interpretation of the toxicological findings during drug development. Due to short timeline, there are limited opportunities for direct communication between pharmaceutical companies and PMDA. Here, we conducted a questionnaire survey on the differences of opinion in consultations with PMDA, and received responses from 23 companies. The different opinion on guidelines between Japan and other countries were mentioned. We would like to discuss this survey results with participants for mutual understanding between companies and PMDA.