Research Paper Series 2009

(No.47: October 2009)

Clinical Development and Review Times of New Drugs in Japan

Taro Ishibashi (Research Fellow, Office of Pharmaceutical Industry Research)
Shunsuke Ono (Associate Professor, Graduate School of Pharmaceutical Sciences, The University of Tokyo)

Changes in clinical development time (initial clinical trial plan notification (CTPN) to NDA), review time (NDA to approval), and development time (initial CTPN to approval) of new drugs approved in Japan during 2000 ・2008 were evaluated.

Clinical development times were fluctuating, with a median of 59.5 months (5.0 years) during 2000 ・2008 and 44.6 months (3.7 years) in 2008. Dispersions were also large, reflecting the diversification of development strategies. Use of foreign clinical data in Japanese NDAs was increasing and contributing to abridge clinical development times. Review times were on a decline since the establishment of PMDA in April 2004, with a median of 20.6 months (1.7 years) and 19.0 months (1.6 years) in 2000 ・2008 and 2008, respectively. No improvement, however, was observed in the time spent from submission of responses to the first set of queries after the Interview Meeting and subsequent queries to the Expert Meeting, which accounted for two-thirds of the review time.

Multiple regression analyses to estimate factors associated with the length of the three time periods suggested that clinical development times were significantly shorter in non-NMEs, conditional approvals, and drugs utilizing foreign clinical data. Results also indicated that review times were significantly shorter in NDAs submitted to PMDA after April 2004 and drugs designated as priority reviews. Conduct of pre-NDA consultations with PMDA shortened the review process but prolonged clinical development.

The applicants・evaluation of PMDA recent performance is rising. Nevertheless, measures such as standardized review timelines with clear milestones, efficient query-and-response procedures, and re-examination of the role of the Pharmaceutical Affairs and Food Sanitation Council should be considered, in addition to the ongoing increase in PMDA staff, implication of pre-NDA evaluation consultations, and strict time management, to further shorten the process time of both the regulatory agencies and applicants and achieve the target review time set for fiscal year 2011 in light of the 5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices.

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