Approval Review Periods and Clinical Development Periods for New Drugs in Japan Survey of Products Approved in 2004
Orie Asaka ( The Office of Pharmaceutical Industry Research, Principal Researcher)
(No. 30: Published August 2005)
Data on approval review periods and clinical development periods were collected and analyzed for new drugs (items reviewed by subcommittees) that received approval in Japan in 2004. The median review period was 17.9 months.This figure has remained in the range of 17–19 months since 2001, and the same trend was observed for products approved in 2004. Furthermore, when broken down into standard review and priority review products, the median review periods were 21.9 months and 7.8 months, respectively.Regarding the time taken by the regulatory authority (review processing period), the median was 13.6 months for standard review applications and 4.7 months for priority review applications.
Furthermore, the clinical development period for drugs containing new active ingredients was 88.8 months (median), the longest since 1996.The total development period, which combines the clinical development period and the review period, also reached a record high, with a median of 115.7 months for products approved in 2004. It was considered possible that this trend toward longer development periods was one factor contributing to the rising development costs, a growing concern in recent years.