Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years

Abstract

The numbers of clinical trial consultations and approved NDAs in FY2007 increased more than 50% compared with FY2004, when the PMDA was established.

The strategy of new drug development has changed significantly; in particular, simultaneous global development has accelerated dramatically in Asia, except in Japan. Based on this situation, the PMDA and MHLW clarified their intention to encourage the pharmaceutical industry to conduct multinational clinical trials from the early stage of clinical development in September 2007. As a result, the number of multinational clinical trials including Japan began to increase quickly.

With regard to the review time of NDAs, it still takes longer than that of FDA or EMEA. Although the situation has begun to improve, the PMDA still needs to further shorten it. The PMDA initiated a new plan starting in April 2007 to add more than 200 reviewers within a period of approximately three years in order to resolve the issue of drug lag.