The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

Abstract

The approval time is defined as the time between the submission date and the approval date and is a regulatory performance measure commonly used in international comparisons. The Japanese Office of Pharmaceutical Industry Research conducted a survey in 2003 to collect unpublished data on approval times of recently approved new drugs in Japan. The results of the survey, which targeted 315 new drug applications (NDAs) approved between 1996 and 2002, showed that the Japanese median approval times were reduced significantly from 41.3 months in 1998 to 17.7 months in 2002 by an approval cohort analysis. When compared with approval times in other countries, Japanese approval times have been gradually approaching those in the United States and the European Union, especially since the establishment of a new review agency in 1997. The reduction in approval times seemed to be achieved by internalizing the review process instead of utilizing external resources. The approval times varied between NDAs with different properties, even though the same performance goals were applied to them.

Keywords

Japan Pharmaceuticals and Medical Devices Evaluation Center New Drug Application (NDA)Approval times Reviewing agency

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