Discussion Based on the Survey Results of Authorities’ Inquiries during NDA Review in Japan

Abstract

We conducted a survey of inquiries from the Pharmaceuticals and Medical Devices Agency (PMDA) for the 13 New Drug Applications (NDAs) submitted by Pfizer Japan Inc. in order to investigate their impact on the NDA review period. The results showed that PMDA raised an average of 130 inquiries (103–180) for nine new chemical entities (NCEs) and an average of 39 inquiries (28–59) for four products with line extensions (PLEs) for the time before and after the first interview meeting. The total number of inquiries received during the period between NDA submission and approval was on average 300 (167–432) for seven NCEs and 82 (53–123) for four PLEs. It was recognized that the NDA review period correlated with the total number of inquiries, the total number of inquiries with potentially high impact on approval (inquiries with high impact), and the frequency of inquiries including those with high impact, which were received during the period between NDA submission and approval. The survey results suggested the possibility that the approval timeline would be affected by these factors related to inquiries from PMDA.