Duration of Approval Review and Clinical Development of New Drugs in Japan A Survey of Drugs Approved in 2004
Orie Azumi, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute, Japan
(No.30: Published in August 2005)
Data on the approval review period and clinical development period were collected and analyzed for new drugs approved in Japan in 2004 (products discussed by the Subcommittee). The median review period was 17.9 months. This value has remained in the range of 17-19 months since 2001, and the same trend was observed for items approved in 2004. The median time for normal review and priority review was 21.9 months and 7.8 months, respectively. The median time taken by the regulatory authorities (examination processing time) was 13.6 months and 4.7 months for regular and priority review items, respectively.
The clinical development period for drugs containing new active ingredients was 88.8 months (median), the longest since 1996. The median duration of the total development period, which includes both the clinical development period and the review period, was 115.7 months for products approved in 2004, the longest on record. This lengthening of development time may be one of the factors contributing to the increase in development costs, which have become a growing concern in recent years.